Trial Outcomes & Findings for Apical Suspension Repair for Vault Prolapse In a Three-Arm Randomized Trial Design (NCT NCT02676973)
NCT ID: NCT02676973
Last Updated: 2025-08-26
Results Overview
Failure was defined as any of the following: retreatment for prolapse, any POP-Q measure beyond the hymen, or presence of bother on PFDI vaginal bulge question. Under the permanent failure state assumption, the number of participants shown at each visit includes all participants who were still participating in the study or had a failure outcome prior their withdrawal. Similarly, the denominator number of participants for the cumulative failure at each visit includes all participants who were still participating in the study and attended the visit or had any failure outcome prior their withdrawal or missed visit.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
360 participants
Primary outcome timeframe
6 months through 60 Months
Results posted on
2025-08-26
Participant Flow
Participant milestones
| Measure |
Native Tissue
Transvaginal Native Tissue Repair: Transvaginal Native Tissue Repair is a surgery performed with an incision through the vagina (transvaginal). The surgery is done using both permanent and absorbable
|
Sacral Colpopexy
Open, Robotic, or Laparoscopic: Sacral Colpopexy is a surgery performed either through an incision in the abdomen or through several small incisions with the help of a laparoscope (a slender tube) or
|
Transvaginal Mesh
Uphold� LITE: Transvaginal Mesh Repair is a surgery performed with an incision through the vagina (transvaginal). The surgery is done with a permanent synthetic (man-made) mesh. The mesh is attached t
|
|---|---|---|---|
|
Overall Study
STARTED
|
123
|
121
|
116
|
|
Overall Study
COMPLETED
|
104
|
100
|
92
|
|
Overall Study
NOT COMPLETED
|
19
|
21
|
24
|
Reasons for withdrawal
| Measure |
Native Tissue
Transvaginal Native Tissue Repair: Transvaginal Native Tissue Repair is a surgery performed with an incision through the vagina (transvaginal). The surgery is done using both permanent and absorbable
|
Sacral Colpopexy
Open, Robotic, or Laparoscopic: Sacral Colpopexy is a surgery performed either through an incision in the abdomen or through several small incisions with the help of a laparoscope (a slender tube) or
|
Transvaginal Mesh
Uphold� LITE: Transvaginal Mesh Repair is a surgery performed with an incision through the vagina (transvaginal). The surgery is done with a permanent synthetic (man-made) mesh. The mesh is attached t
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
9
|
8
|
11
|
|
Overall Study
Lost to Follow-up
|
8
|
12
|
8
|
|
Overall Study
Death
|
2
|
1
|
5
|
Baseline Characteristics
Apical Suspension Repair for Vault Prolapse In a Three-Arm Randomized Trial Design
Baseline characteristics by cohort
| Measure |
Native Tissue
n=123 Participants
Transvaginal Native Tissue Repair: Transvaginal Native Tissue Repair is a surgery performed with an incision through the vagina (transvaginal). The surgery is done using both permanent and absorbable
|
Sacral Colpopexy
n=121 Participants
Open, Robotic, or Laparoscopic: Sacral Colpopexy is a surgery performed either through an incision in the abdomen or through several small incisions with the help of a laparoscope (a slender tube) or
|
Transvaginal Mesh
n=116 Participants
Uphold� LITE: Transvaginal Mesh Repair is a surgery performed with an incision through the vagina (transvaginal). The surgery is done with a permanent synthetic (man-made) mesh. The mesh is attached t
|
Total
n=360 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
66.4 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
65.4 years
STANDARD_DEVIATION 8.6 • n=7 Participants
|
66.4 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
66.1 years
STANDARD_DEVIATION 8.7 • n=4 Participants
|
|
Sex/Gender, Customized
Female
|
123 Participants
n=5 Participants
|
121 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
360 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaskan Native
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
101 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
302 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
21 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
98 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
305 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Unknown/ Not Reported
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Marital Status
Divorced/ Separated
|
26 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
|
Marital Status
MARRIED, HUSBAND IN LOUISIANA
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Marital Status
Married /Living with partner
|
82 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
244 Participants
n=4 Participants
|
|
Marital Status
Single (never been married)
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Marital Status
Widowed
|
8 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Education
4-Year College Degree
|
24 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
70 Participants
n=4 Participants
|
|
Education
Associate College Degree
|
28 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
97 Participants
n=4 Participants
|
|
Education
Graduate Degree
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Education
High School/GED
|
47 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
126 Participants
n=4 Participants
|
|
Education
Less than High School
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Education
Unknown/ Not Reported
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Body Mass Index
|
27.9 kg/m^2
STANDARD_DEVIATION 5.5 • n=5 Participants
|
29.5 kg/m^2
STANDARD_DEVIATION 6.4 • n=7 Participants
|
28.7 kg/m^2
STANDARD_DEVIATION 5.1 • n=5 Participants
|
28.7 kg/m^2
STANDARD_DEVIATION 5.8 • n=4 Participants
|
|
Current Smoker
No
|
90 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
260 Participants
n=4 Participants
|
|
Current Smoker
Unknown
|
25 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
74 Participants
n=4 Participants
|
|
Current Smoker
Yes
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Pregnancies
|
3 Number of pregnancies
n=5 Participants
|
3 Number of pregnancies
n=7 Participants
|
3 Number of pregnancies
n=5 Participants
|
3 Number of pregnancies
n=4 Participants
|
|
Vaginal Deliveries
|
3 Number of deliveries
n=5 Participants
|
2 Number of deliveries
n=7 Participants
|
2.5 Number of deliveries
n=5 Participants
|
2 Number of deliveries
n=4 Participants
|
PRIMARY outcome
Timeframe: 6 months through 60 MonthsPopulation: An modified intent-to-treat (ITT) analysis which included all eligible participants who were randomized, received the randomized procedure, and who provided outcome data after baseline was performed.
Failure was defined as any of the following: retreatment for prolapse, any POP-Q measure beyond the hymen, or presence of bother on PFDI vaginal bulge question. Under the permanent failure state assumption, the number of participants shown at each visit includes all participants who were still participating in the study or had a failure outcome prior their withdrawal. Similarly, the denominator number of participants for the cumulative failure at each visit includes all participants who were still participating in the study and attended the visit or had any failure outcome prior their withdrawal or missed visit.
Outcome measures
| Measure |
Native Tissue
n=118 Participants
Transvaginal Native Tissue Repair: Transvaginal Native Tissue Repair is a surgery performed with an incision through the vagina (transvaginal). The surgery is done using both permanent and absorbable
|
Sacral Colpopexy
n=120 Participants
Open, Robotic, or Laparoscopic: Sacral Colpopexy is a surgery performed either through an incision in the abdomen or through several small incisions with the help of a laparoscope (a slender tube) or
|
Transvaginal Mesh
n=113 Participants
Uphold� LITE: Transvaginal Mesh Repair is a surgery performed with an incision through the vagina (transvaginal). The surgery is done with a permanent synthetic (man-made) mesh. The mesh is attached t
|
|---|---|---|---|
|
Number of Participants Considered Failures
54 Months · Non-failure
|
29 Participants
|
30 Participants
|
39 Participants
|
|
Number of Participants Considered Failures
06 Months · Failure
|
19 Participants
|
6 Participants
|
11 Participants
|
|
Number of Participants Considered Failures
06 Months · Non-failure
|
93 Participants
|
108 Participants
|
100 Participants
|
|
Number of Participants Considered Failures
12 Months · Failure
|
31 Participants
|
13 Participants
|
18 Participants
|
|
Number of Participants Considered Failures
12 Months · Non-failure
|
81 Participants
|
96 Participants
|
89 Participants
|
|
Number of Participants Considered Failures
18 Months · Failure
|
38 Participants
|
18 Participants
|
19 Participants
|
|
Number of Participants Considered Failures
18 Months · Non-failure
|
68 Participants
|
86 Participants
|
84 Participants
|
|
Number of Participants Considered Failures
24 Months · Failure
|
43 Participants
|
21 Participants
|
27 Participants
|
|
Number of Participants Considered Failures
24 Months · Non-failure
|
62 Participants
|
83 Participants
|
80 Participants
|
|
Number of Participants Considered Failures
30 Months · Failure
|
49 Participants
|
24 Participants
|
30 Participants
|
|
Number of Participants Considered Failures
30 Months · Non-failure
|
53 Participants
|
75 Participants
|
75 Participants
|
|
Number of Participants Considered Failures
36 Months · Failure
|
53 Participants
|
31 Participants
|
30 Participants
|
|
Number of Participants Considered Failures
36 Months · Non-failure
|
53 Participants
|
69 Participants
|
70 Participants
|
|
Number of Participants Considered Failures
42 Months · Failure
|
55 Participants
|
33 Participants
|
31 Participants
|
|
Number of Participants Considered Failures
42 Months · Non-failure
|
40 Participants
|
57 Participants
|
62 Participants
|
|
Number of Participants Considered Failures
48 Months · Failure
|
55 Participants
|
36 Participants
|
31 Participants
|
|
Number of Participants Considered Failures
48 Months · Non-failure
|
38 Participants
|
50 Participants
|
53 Participants
|
|
Number of Participants Considered Failures
54 Months · Failure
|
55 Participants
|
36 Participants
|
35 Participants
|
|
Number of Participants Considered Failures
60 Months · Failure
|
55 Participants
|
38 Participants
|
37 Participants
|
|
Number of Participants Considered Failures
60 Months · Non-failure
|
21 Participants
|
25 Participants
|
23 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months through 60 MonthsPopulation: An modified intent-to-treat (ITT) analysis which included all eligible participants who were randomized, received the randomized procedure, and who provided outcome data after baseline was performed.
The Pelvic Floor Distress Inventory is a 20-question, validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of an overall scale (range: 0-300) comprised of 3 sub-scales: 1. Pelvic Organ Prolapse Distress Inventory (range: 0-100), 2. Colorectal Anal Distress Inventory (range: 0-100), and 3. Urinary Distress Inventory (range: 0-100). The range of responses for all questions is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Subscale scores are calculated by multiplying the mean value of all questions answered by 25 for the subscale. The range of score for each subscale is: 0-100 with 0 (least distress) to 100 (most distress). The PFDI is calculated as the sum of the three subscales. Lower scores indicate better function / fewer symptoms for the PFDI scale, POPDI subscale, CRADI subscale, and UDI subscale. Change from baseline = (Month \[12, 24, 36\] Score - Baseline Score).
Outcome measures
| Measure |
Native Tissue
n=117 Participants
Transvaginal Native Tissue Repair: Transvaginal Native Tissue Repair is a surgery performed with an incision through the vagina (transvaginal). The surgery is done using both permanent and absorbable
|
Sacral Colpopexy
n=120 Participants
Open, Robotic, or Laparoscopic: Sacral Colpopexy is a surgery performed either through an incision in the abdomen or through several small incisions with the help of a laparoscope (a slender tube) or
|
Transvaginal Mesh
n=113 Participants
Uphold� LITE: Transvaginal Mesh Repair is a surgery performed with an incision through the vagina (transvaginal). The surgery is done with a permanent synthetic (man-made) mesh. The mesh is attached t
|
|---|---|---|---|
|
Change From Baseline PFDI Score
06 Months
|
-75.8 units on a scale
Interval -85.1 to -66.5
|
-80.2 units on a scale
Interval -91.1 to -69.2
|
-79.6 units on a scale
Interval -91.3 to -68.0
|
|
Change From Baseline PFDI Score
12 Months
|
-79.7 units on a scale
Interval -89.0 to -70.4
|
-85.6 units on a scale
Interval -96.8 to -74.4
|
-79.4 units on a scale
Interval -90.7 to -68.1
|
|
Change From Baseline PFDI Score
18 Months
|
-111.7 units on a scale
Interval -122.9 to -100.6
|
-111.8 units on a scale
Interval -123.6 to -100.0
|
-109 units on a scale
Interval -121.7 to -96.4
|
|
Change From Baseline PFDI Score
24 Months
|
-79.8 units on a scale
Interval -90.4 to -69.2
|
-84.9 units on a scale
Interval -96.9 to -72.9
|
-79.9 units on a scale
Interval -90.3 to -69.5
|
|
Change From Baseline PFDI Score
30 Months
|
-106.7 units on a scale
Interval -117.8 to -95.6
|
-112 units on a scale
Interval -124.5 to -99.5
|
-103.8 units on a scale
Interval -116.6 to -90.9
|
|
Change From Baseline PFDI Score
36 Months
|
-78.1 units on a scale
Interval -89.1 to -67.1
|
-83.9 units on a scale
Interval -96.2 to -71.5
|
-79.7 units on a scale
Interval -91.0 to -68.4
|
|
Change From Baseline PFDI Score
42 Months
|
-102.4 units on a scale
Interval -114.4 to -90.3
|
-114.6 units on a scale
Interval -128.4 to -100.8
|
-103.2 units on a scale
Interval -116.1 to -90.4
|
|
Change From Baseline PFDI Score
48 Months
|
-75.8 units on a scale
Interval -87.8 to -63.8
|
-78.4 units on a scale
Interval -92.6 to -64.1
|
-73.9 units on a scale
Interval -88.9 to -58.8
|
|
Change From Baseline PFDI Score
54 Months
|
-109.9 units on a scale
Interval -124.9 to -95.0
|
-109.5 units on a scale
Interval -127.7 to -91.3
|
-107 units on a scale
Interval -122.8 to -91.2
|
|
Change From Baseline PFDI Score
60 Months
|
-68.7 units on a scale
Interval -86.0 to -51.3
|
-84.1 units on a scale
Interval -101.2 to -67.1
|
-67.5 units on a scale
Interval -87.8 to -47.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months through 60 MonthsPopulation: An modified intent-to-treat (ITT) analysis which included all eligible participants who were randomized, received the randomized procedure, and who provided outcome data after baseline was performed.
The Pelvic Floor Distress Inventory is a 20-question, validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of an overall scale (range: 0-300) comprised of 3 sub-scales: 1. Pelvic Organ Prolapse Distress Inventory (range: 0-100), 2. Colorectal Anal Distress Inventory (range: 0-100), and 3. Urinary Distress Inventory (range: 0-100). The range of responses for all questions is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Subscale scores are calculated by multiplying the mean value of all questions answered by 25 for the subscale. The range of score for each subscale is: 0-100 with 0 (least distress) to 100 (most distress). The PFDI is calculated as the sum of the three subscales. Lower scores indicate better function / fewer symptoms for the PFDI scale, POPDI subscale, CRADI subscale, and UDI subscale. Change from baseline = (Month \[12, 24, 36\] Score - Baseline Score).
Outcome measures
| Measure |
Native Tissue
n=116 Participants
Transvaginal Native Tissue Repair: Transvaginal Native Tissue Repair is a surgery performed with an incision through the vagina (transvaginal). The surgery is done using both permanent and absorbable
|
Sacral Colpopexy
n=118 Participants
Open, Robotic, or Laparoscopic: Sacral Colpopexy is a surgery performed either through an incision in the abdomen or through several small incisions with the help of a laparoscope (a slender tube) or
|
Transvaginal Mesh
n=112 Participants
Uphold� LITE: Transvaginal Mesh Repair is a surgery performed with an incision through the vagina (transvaginal). The surgery is done with a permanent synthetic (man-made) mesh. The mesh is attached t
|
|---|---|---|---|
|
Change From Baseline CRADI Score
06 Months
|
-12.3 units on a scale
Interval -15.7 to -8.9
|
-13.1 units on a scale
Interval -16.8 to -9.4
|
-14.2 units on a scale
Interval -18.0 to -10.3
|
|
Change From Baseline CRADI Score
12 Months
|
-12.9 units on a scale
Interval -16.3 to -9.4
|
-14.6 units on a scale
Interval -18.5 to -10.7
|
-14.2 units on a scale
Interval -17.8 to -10.5
|
|
Change From Baseline CRADI Score
24 Months
|
-12.8 units on a scale
Interval -16.7 to -9.0
|
-14.8 units on a scale
Interval -18.9 to -10.6
|
-14 units on a scale
Interval -17.5 to -10.6
|
|
Change From Baseline CRADI Score
36 Months
|
-11.9 units on a scale
Interval -16.2 to -7.6
|
-14.3 units on a scale
Interval -18.7 to -9.9
|
-13.5 units on a scale
Interval -17.6 to -9.3
|
|
Change From Baseline CRADI Score
48 Months
|
-12.3 units on a scale
Interval -16.9 to -7.8
|
-12.2 units on a scale
Interval -17.1 to -7.3
|
-12.7 units on a scale
Interval -18.1 to -7.2
|
|
Change From Baseline CRADI Score
60 Months
|
-7.8 units on a scale
Interval -13.2 to -2.4
|
-10.5 units on a scale
Interval -17.0 to -4.1
|
-13.1 units on a scale
Interval -19.7 to -6.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months through 60 MonthsPopulation: An modified intent-to-treat (ITT) analysis which included all eligible participants who were randomized, received the randomized procedure, and who provided outcome data after baseline was performed.
The Pelvic Floor Distress Inventory is a 20-question, validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of an overall scale (range: 0-300) comprised of 3 sub-scales: 1. Pelvic Organ Prolapse Distress Inventory (range: 0-100), 2. Colorectal Anal Distress Inventory (range: 0-100), and 3. Urinary Distress Inventory (range: 0-100). The range of responses for all questions is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Subscale scores are calculated by multiplying the mean value of all questions answered by 25 for the subscale. The range of score for each subscale is: 0-100 with 0 (least distress) to 100 (most distress). The PFDI is calculated as the sum of the three subscales. Lower scores indicate better function / fewer symptoms for the PFDI scale, POPDI subscale, CRADI subscale, and UDI subscale. Change from baseline = (Month \[12, 24, 36\] Score - Baseline Score).
Outcome measures
| Measure |
Native Tissue
n=117 Participants
Transvaginal Native Tissue Repair: Transvaginal Native Tissue Repair is a surgery performed with an incision through the vagina (transvaginal). The surgery is done using both permanent and absorbable
|
Sacral Colpopexy
n=120 Participants
Open, Robotic, or Laparoscopic: Sacral Colpopexy is a surgery performed either through an incision in the abdomen or through several small incisions with the help of a laparoscope (a slender tube) or
|
Transvaginal Mesh
n=113 Participants
Uphold� LITE: Transvaginal Mesh Repair is a surgery performed with an incision through the vagina (transvaginal). The surgery is done with a permanent synthetic (man-made) mesh. The mesh is attached t
|
|---|---|---|---|
|
Change From Baseline POPDI Score
54 Months
|
-40.9 units on a scale
Interval -48.2 to -33.5
|
-46.5 units on a scale
Interval -52.8 to -40.1
|
-39.8 units on a scale
Interval -46.3 to -33.3
|
|
Change From Baseline POPDI Score
60 Months
|
-33.6 units on a scale
Interval -41.9 to -25.3
|
-42.2 units on a scale
Interval -49.1 to -35.4
|
-32.2 units on a scale
Interval -40.4 to -24.0
|
|
Change From Baseline POPDI Score
06 Months
|
-36.3 units on a scale
Interval -40.4 to -32.1
|
-38 units on a scale
Interval -42.1 to -33.9
|
-37.2 units on a scale
Interval -41.5 to -33.0
|
|
Change From Baseline POPDI Score
12 Months
|
-37.3 units on a scale
Interval -41.6 to -33.0
|
-39.8 units on a scale
Interval -44.2 to -35.4
|
-38.4 units on a scale
Interval -42.6 to -34.2
|
|
Change From Baseline POPDI Score
18 Months
|
-40.9 units on a scale
Interval -46.1 to -35.6
|
-44.2 units on a scale
Interval -48.7 to -39.6
|
-41.8 units on a scale
Interval -47.0 to -36.6
|
|
Change From Baseline POPDI Score
24 Months
|
-40.1 units on a scale
Interval -44.5 to -35.8
|
-40.7 units on a scale
Interval -45.0 to -36.3
|
-37.8 units on a scale
Interval -42.2 to -33.5
|
|
Change From Baseline POPDI Score
30 Months
|
-39.3 units on a scale
Interval -45.0 to -33.6
|
-44.6 units on a scale
Interval -49.4 to -39.8
|
-37.6 units on a scale
Interval -43.8 to -31.5
|
|
Change From Baseline POPDI Score
36 Months
|
-38.1 units on a scale
Interval -43.1 to -33.2
|
-39.3 units on a scale
Interval -43.9 to -34.7
|
-38.2 units on a scale
Interval -42.6 to -33.9
|
|
Change From Baseline POPDI Score
42 Months
|
-36.8 units on a scale
Interval -42.8 to -30.9
|
-45.3 units on a scale
Interval -50.8 to -39.8
|
-40.3 units on a scale
Interval -45.8 to -34.8
|
|
Change From Baseline POPDI Score
48 Months
|
-36.6 units on a scale
Interval -41.8 to -31.4
|
-38.2 units on a scale
Interval -42.9 to -33.5
|
-37.1 units on a scale
Interval -42.4 to -31.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months through 60 MonthsPopulation: An modified intent-to-treat (ITT) analysis which included all eligible participants who were randomized, received the randomized procedure, and who provided outcome data after baseline was performed.
The Pelvic Floor Distress Inventory is a 20-question, validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of an overall scale (range: 0-300) comprised of 3 sub-scales: 1. Pelvic Organ Prolapse Distress Inventory (range: 0-100), 2. Colorectal Anal Distress Inventory (range: 0-100), and 3. Urinary Distress Inventory (range: 0-100). The range of responses for all questions is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Subscale scores are calculated by multiplying the mean value of all questions answered by 25 for the subscale. The range of score for each subscale is: 0-100 with 0 (least distress) to 100 (most distress). The PFDI is calculated as the sum of the three subscales. Lower scores indicate better function / fewer symptoms for the PFDI scale, POPDI subscale, CRADI subscale, and UDI subscale. Change from baseline = (Month \[12, 24, 36\] Score - Baseline Score).
Outcome measures
| Measure |
Native Tissue
n=116 Participants
Transvaginal Native Tissue Repair: Transvaginal Native Tissue Repair is a surgery performed with an incision through the vagina (transvaginal). The surgery is done using both permanent and absorbable
|
Sacral Colpopexy
n=118 Participants
Open, Robotic, or Laparoscopic: Sacral Colpopexy is a surgery performed either through an incision in the abdomen or through several small incisions with the help of a laparoscope (a slender tube) or
|
Transvaginal Mesh
n=112 Participants
Uphold� LITE: Transvaginal Mesh Repair is a surgery performed with an incision through the vagina (transvaginal). The surgery is done with a permanent synthetic (man-made) mesh. The mesh is attached t
|
|---|---|---|---|
|
Change From Baseline UDI Score
06 Months
|
-27.3 units on a scale
Interval -32.1 to -22.4
|
-29.3 units on a scale
Interval -35.1 to -23.4
|
-28.2 units on a scale
Interval -34.1 to -22.3
|
|
Change From Baseline UDI Score
12 Months
|
-29.5 units on a scale
Interval -34.1 to -25.0
|
-31.2 units on a scale
Interval -36.8 to -25.7
|
-26.9 units on a scale
Interval -32.7 to -21.1
|
|
Change From Baseline UDI Score
24 Months
|
-26.8 units on a scale
Interval -32.1 to -21.5
|
-29.5 units on a scale
Interval -35.4 to -23.5
|
-28 units on a scale
Interval -33.3 to -22.7
|
|
Change From Baseline UDI Score
36 Months
|
-28 units on a scale
Interval -33.0 to -23.0
|
-30.2 units on a scale
Interval -36.0 to -24.4
|
-28 units on a scale
Interval -33.7 to -22.3
|
|
Change From Baseline UDI Score
48 Months
|
-26.9 units on a scale
Interval -33.1 to -20.6
|
-27.9 units on a scale
Interval -35.4 to -20.5
|
-24.1 units on a scale
Interval -31.4 to -16.8
|
|
Change From Baseline UDI Score
60 Months
|
-27.3 units on a scale
Interval -36.4 to -18.2
|
-31.4 units on a scale
Interval -40.4 to -22.3
|
-22.2 units on a scale
Interval -32.1 to -12.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months through 60 MonthsPopulation: An modified intent-to-treat (ITT) analysis which included all eligible participants who were randomized, received the randomized procedure, and who provided outcome data after baseline was performed.
The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of an overall score (range 0-300), 3 subscales (7 questions each): the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). The range of responses on all questions is 0-3 with (0) Not at all ... (3), Quite a bit. Subscale scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of scores for each subscale is: 0-100 with 0 (least negative impact) to 100 (most negative impact). The PFIQ is the sum of the three subscales. Lower scores indicate better function / fewer symptoms for the PFIQ score, UIQ score, POPIQ score, and CRAIQ score. Change = (Week \[12, 24\] Score - Baseline Score).
Outcome measures
| Measure |
Native Tissue
n=116 Participants
Transvaginal Native Tissue Repair: Transvaginal Native Tissue Repair is a surgery performed with an incision through the vagina (transvaginal). The surgery is done using both permanent and absorbable
|
Sacral Colpopexy
n=118 Participants
Open, Robotic, or Laparoscopic: Sacral Colpopexy is a surgery performed either through an incision in the abdomen or through several small incisions with the help of a laparoscope (a slender tube) or
|
Transvaginal Mesh
n=112 Participants
Uphold� LITE: Transvaginal Mesh Repair is a surgery performed with an incision through the vagina (transvaginal). The surgery is done with a permanent synthetic (man-made) mesh. The mesh is attached t
|
|---|---|---|---|
|
Change From Baseline PFIQ Score
06 Months
|
-43.9 units on a scale
Interval -54.2 to -33.5
|
-46.6 units on a scale
Interval -56.8 to -36.5
|
-47 units on a scale
Interval -58.4 to -35.5
|
|
Change From Baseline PFIQ Score
12 Months
|
-45.8 units on a scale
Interval -57.4 to -34.3
|
-46.9 units on a scale
Interval -57.1 to -36.7
|
-46.8 units on a scale
Interval -59.6 to -34.1
|
|
Change From Baseline PFIQ Score
24 Months
|
-41.1 units on a scale
Interval -53.1 to -29.0
|
-46.4 units on a scale
Interval -57.4 to -35.5
|
-45.4 units on a scale
Interval -56.9 to -33.9
|
|
Change From Baseline PFIQ Score
36 Months
|
-46.2 units on a scale
Interval -57.9 to -34.4
|
-45.9 units on a scale
Interval -57.3 to -34.5
|
-40.3 units on a scale
Interval -52.6 to -28.1
|
|
Change From Baseline PFIQ Score
48 Months
|
-39.2 units on a scale
Interval -50.7 to -27.6
|
-42.5 units on a scale
Interval -57.2 to -27.7
|
-32.2 units on a scale
Interval -46.7 to -17.8
|
|
Change From Baseline PFIQ Score
60 Months
|
-32.4 units on a scale
Interval -54.0 to -10.8
|
-46.9 units on a scale
Interval -66.7 to -27.1
|
-21.8 units on a scale
Interval -37.6 to -5.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months through 60 MonthsPopulation: An modified intent-to-treat (ITT) analysis which included all eligible participants who were randomized, received the randomized procedure, and who provided outcome data after baseline was performed.
The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of an overall score (range 0-300), 3 subscales (7 questions each): the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). The range of responses on all questions is 0-3 with (0) Not at all ... (3), Quite a bit. Subscale scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of scores for each subscale is: 0-100 with 0 (least negative impact) to 100 (most negative impact). The PFIQ is the sum of the three subscales. Lower scores indicate better function / fewer symptoms for the PFIQ score, UIQ score, POPIQ score, and CRAIQ score. Change = (Week \[12, 24\] Score - Baseline Score).
Outcome measures
| Measure |
Native Tissue
n=115 Participants
Transvaginal Native Tissue Repair: Transvaginal Native Tissue Repair is a surgery performed with an incision through the vagina (transvaginal). The surgery is done using both permanent and absorbable
|
Sacral Colpopexy
n=118 Participants
Open, Robotic, or Laparoscopic: Sacral Colpopexy is a surgery performed either through an incision in the abdomen or through several small incisions with the help of a laparoscope (a slender tube) or
|
Transvaginal Mesh
n=112 Participants
Uphold� LITE: Transvaginal Mesh Repair is a surgery performed with an incision through the vagina (transvaginal). The surgery is done with a permanent synthetic (man-made) mesh. The mesh is attached t
|
|---|---|---|---|
|
Change From Baseline CRAIQ Score
06 Months
|
-10.1 units on a scale
Interval -13.8 to -6.5
|
-9.1 units on a scale
Interval -12.0 to -6.1
|
-9.2 units on a scale
Interval -12.9 to -5.5
|
|
Change From Baseline CRAIQ Score
12 Months
|
-10.2 units on a scale
Interval -14.3 to -6.1
|
-9.4 units on a scale
Interval -12.5 to -6.3
|
-9.7 units on a scale
Interval -14.1 to -5.3
|
|
Change From Baseline CRAIQ Score
24 Months
|
-7.1 units on a scale
Interval -11.5 to -2.7
|
-9.8 units on a scale
Interval -13.4 to -6.1
|
-9.2 units on a scale
Interval -13.1 to -5.4
|
|
Change From Baseline CRAIQ Score
36 Months
|
-7.6 units on a scale
Interval -11.5 to -3.8
|
-9.4 units on a scale
Interval -13.0 to -5.8
|
-6.3 units on a scale
Interval -10.5 to -2.1
|
|
Change From Baseline CRAIQ Score
48 Months
|
-5.2 units on a scale
Interval -9.5 to -0.9
|
-9.3 units on a scale
Interval -14.1 to -4.4
|
-4.3 units on a scale
Interval -9.3 to 0.8
|
|
Change From Baseline CRAIQ Score
60 Months
|
-3.8 units on a scale
Interval -11.4 to 3.8
|
-6.8 units on a scale
Interval -13.1 to -0.5
|
-2.4 units on a scale
Interval -9.4 to 4.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months through 60 MonthsPopulation: An modified intent-to-treat (ITT) analysis which included all eligible participants who were randomized, received the randomized procedure, and who provided outcome data after baseline was performed.
The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of an overall score (range 0-300), 3 subscales (7 questions each): the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). The range of responses on all questions is 0-3 with (0) Not at all ... (3), Quite a bit. Subscale scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of scores for each subscale is: 0-100 with 0 (least negative impact) to 100 (most negative impact). The PFIQ is the sum of the three subscales. Lower scores indicate better function / fewer symptoms for the PFIQ score, UIQ score, POPIQ score, and CRAIQ score. Change = (Week \[12, 24\] Score - Baseline Score).
Outcome measures
| Measure |
Native Tissue
n=115 Participants
Transvaginal Native Tissue Repair: Transvaginal Native Tissue Repair is a surgery performed with an incision through the vagina (transvaginal). The surgery is done using both permanent and absorbable
|
Sacral Colpopexy
n=118 Participants
Open, Robotic, or Laparoscopic: Sacral Colpopexy is a surgery performed either through an incision in the abdomen or through several small incisions with the help of a laparoscope (a slender tube) or
|
Transvaginal Mesh
n=112 Participants
Uphold� LITE: Transvaginal Mesh Repair is a surgery performed with an incision through the vagina (transvaginal). The surgery is done with a permanent synthetic (man-made) mesh. The mesh is attached t
|
|---|---|---|---|
|
Change From Baseline POPIQ Score
06 Months
|
-19 units on a scale
Interval -23.6 to -14.3
|
-19 units on a scale
Interval -23.8 to -14.1
|
-19.1 units on a scale
Interval -23.8 to -14.3
|
|
Change From Baseline POPIQ Score
12 Months
|
-18.6 units on a scale
Interval -23.4 to -13.8
|
-19.5 units on a scale
Interval -24.1 to -14.9
|
-18.2 units on a scale
Interval -23.4 to -13.0
|
|
Change From Baseline POPIQ Score
24 Months
|
-18.3 units on a scale
Interval -23.5 to -13.1
|
-20 units on a scale
Interval -24.5 to -15.5
|
-18.4 units on a scale
Interval -23.2 to -13.6
|
|
Change From Baseline POPIQ Score
36 Months
|
-20.9 units on a scale
Interval -26.2 to -15.6
|
-18.8 units on a scale
Interval -23.5 to -14.1
|
-17.9 units on a scale
Interval -22.6 to -13.1
|
|
Change From Baseline POPIQ Score
48 Months
|
-17.9 units on a scale
Interval -24.1 to -11.7
|
-17.3 units on a scale
Interval -23.2 to -11.4
|
-17 units on a scale
Interval -22.8 to -11.2
|
|
Change From Baseline POPIQ Score
60 Months
|
-17.1 units on a scale
Interval -26.8 to -7.3
|
-22.3 units on a scale
Interval -31.3 to -13.3
|
-10.9 units on a scale
Interval -16.9 to -4.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months through 60 MonthsPopulation: An modified intent-to-treat (ITT) analysis which included all eligible participants who were randomized, received the randomized procedure, and who provided outcome data after baseline was performed.
The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of an overall score (range 0-300), 3 subscales (7 questions each): the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). The range of responses on all questions is 0-3 with (0) Not at all ... (3), Quite a bit. Subscale scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of scores for each subscale is: 0-100 with 0 (least negative impact) to 100 (most negative impact). The PFIQ is the sum of the three subscales. Lower scores indicate better function / fewer symptoms for the PFIQ score, UIQ score, POPIQ score, and CRAIQ score. Change = (Week \[12, 24\] Score - Baseline Score).
Outcome measures
| Measure |
Native Tissue
n=116 Participants
Transvaginal Native Tissue Repair: Transvaginal Native Tissue Repair is a surgery performed with an incision through the vagina (transvaginal). The surgery is done using both permanent and absorbable
|
Sacral Colpopexy
n=118 Participants
Open, Robotic, or Laparoscopic: Sacral Colpopexy is a surgery performed either through an incision in the abdomen or through several small incisions with the help of a laparoscope (a slender tube) or
|
Transvaginal Mesh
n=112 Participants
Uphold� LITE: Transvaginal Mesh Repair is a surgery performed with an incision through the vagina (transvaginal). The surgery is done with a permanent synthetic (man-made) mesh. The mesh is attached t
|
|---|---|---|---|
|
Change From Baseline UIQ Score
06 Months
|
-15 units on a scale
Interval -19.4 to -10.6
|
-18.7 units on a scale
Interval -23.4 to -14.1
|
-18.9 units on a scale
Interval -23.9 to -13.9
|
|
Change From Baseline UIQ Score
12 Months
|
-17 units on a scale
Interval -21.5 to -12.6
|
-18.3 units on a scale
Interval -22.8 to -13.8
|
-18.5 units on a scale
Interval -23.2 to -13.7
|
|
Change From Baseline UIQ Score
24 Months
|
-15.7 units on a scale
Interval -20.3 to -11.0
|
-17 units on a scale
Interval -22.0 to -11.9
|
-17.8 units on a scale
Interval -22.5 to -13.0
|
|
Change From Baseline UIQ Score
36 Months
|
-17.6 units on a scale
Interval -22.7 to -12.6
|
-17.7 units on a scale
Interval -22.9 to -12.5
|
-16.3 units on a scale
Interval -21.6 to -11.0
|
|
Change From Baseline UIQ Score
48 Months
|
-16.3 units on a scale
Interval -21.2 to -11.3
|
-15.9 units on a scale
Interval -22.0 to -9.9
|
-11 units on a scale
Interval -16.9 to -5.0
|
|
Change From Baseline UIQ Score
60 Months
|
-11.5 units on a scale
Interval -19.7 to -3.3
|
-17.8 units on a scale
Interval -26.3 to -9.2
|
-8.4 units on a scale
Interval -14.7 to -2.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months through 60 MonthsPopulation: An modified intent-to-treat (ITT) analysis which included all eligible participants who were randomized, received the randomized procedure, and who provided outcome data after baseline was performed.
Functional Activity Scale measuring the impact of incontinence symptoms on a woman's daily activities is composed of 13 questions about normal and physically strenuous daily activities. The range of responses on the individual questions is (1) No difficulty,... (5) Not able to do it. Scores are calculated by subtracting from the maximum sum (5\*13=65) the product of the mean response and number of questions, then dividing by the total range of sums (65 - 13 = 52) and multiplying by 100. The range of responses is: 0-100 with 0 (worse functionality) to 100 (Better functionality). Change = (Month \[6, 12, 18, 24, and 36\] Score - Baseline Score).
Outcome measures
| Measure |
Native Tissue
n=116 Participants
Transvaginal Native Tissue Repair: Transvaginal Native Tissue Repair is a surgery performed with an incision through the vagina (transvaginal). The surgery is done using both permanent and absorbable
|
Sacral Colpopexy
n=117 Participants
Open, Robotic, or Laparoscopic: Sacral Colpopexy is a surgery performed either through an incision in the abdomen or through several small incisions with the help of a laparoscope (a slender tube) or
|
Transvaginal Mesh
n=112 Participants
Uphold� LITE: Transvaginal Mesh Repair is a surgery performed with an incision through the vagina (transvaginal). The surgery is done with a permanent synthetic (man-made) mesh. The mesh is attached t
|
|---|---|---|---|
|
Change From Baseline Functional Activity Scale
06 Months
|
3.9 units on a scale
Interval 1.6 to 6.2
|
6.2 units on a scale
Interval 3.1 to 9.3
|
6.6 units on a scale
Interval 3.5 to 9.7
|
|
Change From Baseline Functional Activity Scale
12 Months
|
4.6 units on a scale
Interval 2.2 to 7.0
|
5.3 units on a scale
Interval 2.2 to 8.4
|
6.1 units on a scale
Interval 3.0 to 9.3
|
|
Change From Baseline Functional Activity Scale
24 Months
|
3.5 units on a scale
Interval 0.6 to 6.5
|
6.1 units on a scale
Interval 2.7 to 9.5
|
5.7 units on a scale
Interval 2.7 to 8.7
|
|
Change From Baseline Functional Activity Scale
36 Months
|
2.6 units on a scale
Interval -0.4 to 5.5
|
7 units on a scale
Interval 3.5 to 10.4
|
4.9 units on a scale
Interval 1.5 to 8.3
|
|
Change From Baseline Functional Activity Scale
48 Months
|
2.4 units on a scale
Interval -1.5 to 6.4
|
5.3 units on a scale
Interval 1.9 to 8.7
|
2.7 units on a scale
Interval -1.3 to 6.6
|
|
Change From Baseline Functional Activity Scale
60 Months
|
-0.8 units on a scale
Interval -3.8 to 2.1
|
7.3 units on a scale
Interval 2.2 to 12.3
|
-0.7 units on a scale
Interval -5.2 to 3.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months through 60 MonthsPopulation: An modified intent-to-treat (ITT) analysis which included all eligible participants who were randomized, received the randomized procedure, and who provided outcome data after baseline was performed.
The Body Part Pain Scale measuring the pain experienced in the lower abdomen and pelvic region of the body is composed of 7 questions, each with a yes (1) or no (0) questions about experiencing pain followed by an intensity rating: 0 (No pain),..., 10 (Most intense). The score is calculated as the average of the responses. The range of responses is: 0-10 with 0 (No pain) to 10 (most intense pain). Lower scores indicate better function / fewer symptoms. Change = (Month \[6, 12, 18, 24, and 36\] Score - Baseline Score).
Outcome measures
| Measure |
Native Tissue
n=116 Participants
Transvaginal Native Tissue Repair: Transvaginal Native Tissue Repair is a surgery performed with an incision through the vagina (transvaginal). The surgery is done using both permanent and absorbable
|
Sacral Colpopexy
n=117 Participants
Open, Robotic, or Laparoscopic: Sacral Colpopexy is a surgery performed either through an incision in the abdomen or through several small incisions with the help of a laparoscope (a slender tube) or
|
Transvaginal Mesh
n=112 Participants
Uphold� LITE: Transvaginal Mesh Repair is a surgery performed with an incision through the vagina (transvaginal). The surgery is done with a permanent synthetic (man-made) mesh. The mesh is attached t
|
|---|---|---|---|
|
Change From Baseline Body Part Pain Scale
06 Months
|
-0.4 units on a scale
Interval -0.6 to -0.1
|
-0.5 units on a scale
Interval -0.7 to -0.2
|
-0.6 units on a scale
Interval -0.9 to -0.4
|
|
Change From Baseline Body Part Pain Scale
12 Months
|
-0.4 units on a scale
Interval -0.6 to -0.2
|
-0.5 units on a scale
Interval -0.7 to -0.2
|
-0.7 units on a scale
Interval -1.0 to -0.4
|
|
Change From Baseline Body Part Pain Scale
24 Months
|
-0.4 units on a scale
Interval -0.7 to -0.2
|
-0.5 units on a scale
Interval -0.8 to -0.2
|
-0.7 units on a scale
Interval -0.9 to -0.4
|
|
Change From Baseline Body Part Pain Scale
36 Months
|
-0.3 units on a scale
Interval -0.5 to -0.1
|
-0.6 units on a scale
Interval -0.9 to -0.2
|
-0.7 units on a scale
Interval -1.0 to -0.4
|
|
Change From Baseline Body Part Pain Scale
48 Months
|
-0.2 units on a scale
Interval -0.4 to 0.0
|
-0.5 units on a scale
Interval -0.8 to -0.1
|
-0.5 units on a scale
Interval -0.7 to -0.2
|
|
Change From Baseline Body Part Pain Scale
60 Months
|
-0.3 units on a scale
Interval -0.5 to 0.0
|
-0.7 units on a scale
Interval -1.1 to -0.3
|
-0.2 units on a scale
Interval -0.6 to 0.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months through 60 MonthsPopulation: An modified intent-to-treat (ITT) analysis which included all eligible participants who were randomized, received the randomized procedure, and who provided outcome data after baseline was performed.
The Surgical Pain Scale measuring the post-surgical pain experienced by a subject is composed of 4 questions: Pain at Rest (range 0-10), Pain with Normal Activities (range 0-10), Pain with Exercise (range 0-10), and Intensity of Worst Pain (range 0-10). Lower scores indicate better less pain for the Rest subscale, Normal subscale, Exercise Subscale, and Worst Subscale. Change = (Month \[6, 12, 18, 24, and 36\] Score - Baseline Score).
Outcome measures
| Measure |
Native Tissue
n=116 Participants
Transvaginal Native Tissue Repair: Transvaginal Native Tissue Repair is a surgery performed with an incision through the vagina (transvaginal). The surgery is done using both permanent and absorbable
|
Sacral Colpopexy
n=118 Participants
Open, Robotic, or Laparoscopic: Sacral Colpopexy is a surgery performed either through an incision in the abdomen or through several small incisions with the help of a laparoscope (a slender tube) or
|
Transvaginal Mesh
n=112 Participants
Uphold� LITE: Transvaginal Mesh Repair is a surgery performed with an incision through the vagina (transvaginal). The surgery is done with a permanent synthetic (man-made) mesh. The mesh is attached t
|
|---|---|---|---|
|
Change From Baseline Surgical Pain Scale Rest Score
06 Months
|
-0.6 units on a scale
Interval -1.0 to -0.2
|
-0.5 units on a scale
Interval -0.9 to -0.1
|
-0.7 units on a scale
Interval -1.1 to -0.3
|
|
Change From Baseline Surgical Pain Scale Rest Score
12 Months
|
-0.5 units on a scale
Interval -1.0 to -0.1
|
-0.4 units on a scale
Interval -0.8 to 0.1
|
-0.8 units on a scale
Interval -1.2 to -0.4
|
|
Change From Baseline Surgical Pain Scale Rest Score
24 Months
|
-0.5 units on a scale
Interval -1.0 to 0.0
|
-0.4 units on a scale
Interval -0.9 to 0.1
|
-0.6 units on a scale
Interval -1.1 to -0.2
|
|
Change From Baseline Surgical Pain Scale Rest Score
36 Months
|
-0.5 units on a scale
Interval -0.9 to 0.0
|
-0.6 units on a scale
Interval -1.1 to -0.2
|
-0.2 units on a scale
Interval -0.7 to 0.3
|
|
Change From Baseline Surgical Pain Scale Rest Score
48 Months
|
-0.9 units on a scale
Interval -1.4 to -0.4
|
-0.5 units on a scale
Interval -1.0 to 0.1
|
-0.2 units on a scale
Interval -0.8 to 0.5
|
|
Change From Baseline Surgical Pain Scale Rest Score
60 Months
|
-0.7 units on a scale
Interval -1.5 to 0.0
|
-1.1 units on a scale
Interval -2.0 to -0.3
|
0.2 units on a scale
Interval -0.7 to 1.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months through 60 MonthsPopulation: An modified intent-to-treat (ITT) analysis which included all eligible participants who were randomized, received the randomized procedure, and who provided outcome data after baseline was performed.
The Surgical Pain Scale measuring the post-surgical pain experienced by a subject is composed of 4 questions: Pain at Rest (range 0-10), Pain with Normal Activities (range 0-10), Pain with Exercise (range 0-10), and Intensity of Worst Pain (range 0-10). Lower scores indicate better less pain for the Rest subscale, Normal subscale, Exercise Subscale, and Worst Subscale. Change = (Month \[6, 12, 18, 24, and 36\] Score - Baseline Score).
Outcome measures
| Measure |
Native Tissue
n=116 Participants
Transvaginal Native Tissue Repair: Transvaginal Native Tissue Repair is a surgery performed with an incision through the vagina (transvaginal). The surgery is done using both permanent and absorbable
|
Sacral Colpopexy
n=118 Participants
Open, Robotic, or Laparoscopic: Sacral Colpopexy is a surgery performed either through an incision in the abdomen or through several small incisions with the help of a laparoscope (a slender tube) or
|
Transvaginal Mesh
n=112 Participants
Uphold� LITE: Transvaginal Mesh Repair is a surgery performed with an incision through the vagina (transvaginal). The surgery is done with a permanent synthetic (man-made) mesh. The mesh is attached t
|
|---|---|---|---|
|
Change From Baseline Surgical Pain Scale Normal Score
06 Months
|
-0.5 units on a scale
Interval -0.9 to -0.1
|
-0.7 units on a scale
Interval -1.2 to -0.2
|
-0.9 units on a scale
Interval -1.4 to -0.4
|
|
Change From Baseline Surgical Pain Scale Normal Score
12 Months
|
-0.5 units on a scale
Interval -0.9 to -0.1
|
-0.5 units on a scale
Interval -1.0 to -0.1
|
-1 units on a scale
Interval -1.5 to -0.5
|
|
Change From Baseline Surgical Pain Scale Normal Score
24 Months
|
-0.6 units on a scale
Interval -1.0 to -0.2
|
-0.8 units on a scale
Interval -1.3 to -0.3
|
-1 units on a scale
Interval -1.5 to -0.4
|
|
Change From Baseline Surgical Pain Scale Normal Score
36 Months
|
-0.5 units on a scale
Interval -1.0 to 0.1
|
-0.7 units on a scale
Interval -1.2 to -0.2
|
-0.5 units on a scale
Interval -1.0 to 0.1
|
|
Change From Baseline Surgical Pain Scale Normal Score
48 Months
|
-0.4 units on a scale
Interval -1.1 to 0.2
|
-0.6 units on a scale
Interval -1.1 to 0.0
|
-0.6 units on a scale
Interval -1.3 to 0.1
|
|
Change From Baseline Surgical Pain Scale Normal Score
60 Months
|
-0.4 units on a scale
Interval -1.1 to 0.3
|
-1 units on a scale
Interval -2.0 to 0.0
|
0.5 units on a scale
Interval -0.7 to 1.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months through 60 MonthsPopulation: An modified intent-to-treat (ITT) analysis which included all eligible participants who were randomized, received the randomized procedure, and who provided outcome data after baseline was performed.
The Surgical Pain Scale measuring the post-surgical pain experienced by a subject is composed of 4 questions: Pain at Rest (range 0-10), Pain with Normal Activities (range 0-10), Pain with Exercise (range 0-10), and Intensity of Worst Pain (range 0-10). Lower scores indicate better less pain for the Rest subscale, Normal subscale, Exercise Subscale, and Worst Subscale. Change = (Month \[6, 12, 18, 24, and 36\] Score - Baseline Score).
Outcome measures
| Measure |
Native Tissue
n=75 Participants
Transvaginal Native Tissue Repair: Transvaginal Native Tissue Repair is a surgery performed with an incision through the vagina (transvaginal). The surgery is done using both permanent and absorbable
|
Sacral Colpopexy
n=74 Participants
Open, Robotic, or Laparoscopic: Sacral Colpopexy is a surgery performed either through an incision in the abdomen or through several small incisions with the help of a laparoscope (a slender tube) or
|
Transvaginal Mesh
n=74 Participants
Uphold� LITE: Transvaginal Mesh Repair is a surgery performed with an incision through the vagina (transvaginal). The surgery is done with a permanent synthetic (man-made) mesh. The mesh is attached t
|
|---|---|---|---|
|
Change From Baseline Surgical Pain Scale Exercise Score
06 Months
|
-0.6 units on a scale
Interval -1.4 to 0.2
|
-1.5 units on a scale
Interval -2.4 to -0.5
|
-1.7 units on a scale
Interval -2.5 to -0.8
|
|
Change From Baseline Surgical Pain Scale Exercise Score
12 Months
|
-0.8 units on a scale
Interval -1.4 to -0.2
|
-1.4 units on a scale
Interval -2.3 to -0.5
|
-1.3 units on a scale
Interval -2.2 to -0.5
|
|
Change From Baseline Surgical Pain Scale Exercise Score
24 Months
|
-1.3 units on a scale
Interval -2.2 to -0.4
|
-0.4 units on a scale
Interval -1.5 to 0.7
|
-1.6 units on a scale
Interval -2.6 to -0.6
|
|
Change From Baseline Surgical Pain Scale Exercise Score
36 Months
|
-1.1 units on a scale
Interval -2.0 to -0.1
|
-1.2 units on a scale
Interval -2.1 to -0.2
|
-1.7 units on a scale
Interval -2.7 to -0.7
|
|
Change From Baseline Surgical Pain Scale Exercise Score
48 Months
|
-1.3 units on a scale
Interval -2.6 to -0.1
|
-0.7 units on a scale
Interval -1.8 to 0.5
|
-1.4 units on a scale
Interval -2.7 to 0.0
|
|
Change From Baseline Surgical Pain Scale Exercise Score
60 Months
|
-0.6 units on a scale
Interval -1.7 to 0.5
|
-2.9 units on a scale
Interval -4.4 to -1.5
|
0.4 units on a scale
Interval -1.6 to 2.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months through 60 MonthsPopulation: An modified intent-to-treat (ITT) analysis which included all eligible participants who were randomized, received the randomized procedure, and who provided outcome data after baseline was performed.
The Surgical Pain Scale measuring the post-surgical pain experienced by a subject is composed of 4 questions: Pain at Rest (range 0-10), Pain with Normal Activities (range 0-10), Pain with Exercise (range 0-10), and Intensity of Worst Pain (range 0-10). Lower scores indicate better less pain for the Rest subscale, Normal subscale, Exercise Subscale, and Worst Subscale. Change = (Month \[6, 12, 18, 24, and 36\] Score - Baseline Score).
Outcome measures
| Measure |
Native Tissue
n=116 Participants
Transvaginal Native Tissue Repair: Transvaginal Native Tissue Repair is a surgery performed with an incision through the vagina (transvaginal). The surgery is done using both permanent and absorbable
|
Sacral Colpopexy
n=118 Participants
Open, Robotic, or Laparoscopic: Sacral Colpopexy is a surgery performed either through an incision in the abdomen or through several small incisions with the help of a laparoscope (a slender tube) or
|
Transvaginal Mesh
n=112 Participants
Uphold� LITE: Transvaginal Mesh Repair is a surgery performed with an incision through the vagina (transvaginal). The surgery is done with a permanent synthetic (man-made) mesh. The mesh is attached t
|
|---|---|---|---|
|
Change From Baseline Surgical Pain Scale Worst Score
06 Months
|
-0.7 units on a scale
Interval -1.1 to -0.2
|
-1.1 units on a scale
Interval -1.7 to -0.5
|
-0.9 units on a scale
Interval -1.4 to -0.4
|
|
Change From Baseline Surgical Pain Scale Worst Score
12 Months
|
-0.8 units on a scale
Interval -1.2 to -0.4
|
-0.9 units on a scale
Interval -1.5 to -0.4
|
-1.1 units on a scale
Interval -1.6 to -0.6
|
|
Change From Baseline Surgical Pain Scale Worst Score
24 Months
|
-0.6 units on a scale
Interval -1.2 to 0.0
|
-1.2 units on a scale
Interval -1.8 to -0.6
|
-1 units on a scale
Interval -1.5 to -0.5
|
|
Change From Baseline Surgical Pain Scale Worst Score
36 Months
|
-0.4 units on a scale
Interval -1.0 to 0.2
|
-1.1 units on a scale
Interval -1.8 to -0.5
|
-0.4 units on a scale
Interval -1.0 to 0.1
|
|
Change From Baseline Surgical Pain Scale Worst Score
48 Months
|
-0.3 units on a scale
Interval -1.0 to 0.5
|
-1 units on a scale
Interval -1.6 to -0.3
|
-0.2 units on a scale
Interval -0.8 to 0.4
|
|
Change From Baseline Surgical Pain Scale Worst Score
60 Months
|
-0.6 units on a scale
Interval -1.3 to 0.2
|
-1.7 units on a scale
Interval -2.7 to -0.7
|
0.8 units on a scale
Interval -0.1 to 1.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months through 60 MonthsPopulation: An modified intent-to-treat (ITT) analysis which included all eligible participants who were randomized, received the randomized procedure, and who provided outcome data after baseline was performed.
The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) is a questionnaire measuring the impact of incontinence symptoms on sexual function and satisfaction. The PISQ-IR Sexually Active-Average Score (SA-AVG) ranges from 0 to 5 with higher scores indicating better function/satisfaction. The change from baseline outcome is calculated as the difference in score at 6, 12, 18, 24, and 36 months and the score at baseline.
Outcome measures
| Measure |
Native Tissue
n=44 Participants
Transvaginal Native Tissue Repair: Transvaginal Native Tissue Repair is a surgery performed with an incision through the vagina (transvaginal). The surgery is done using both permanent and absorbable
|
Sacral Colpopexy
n=43 Participants
Open, Robotic, or Laparoscopic: Sacral Colpopexy is a surgery performed either through an incision in the abdomen or through several small incisions with the help of a laparoscope (a slender tube) or
|
Transvaginal Mesh
n=46 Participants
Uphold� LITE: Transvaginal Mesh Repair is a surgery performed with an incision through the vagina (transvaginal). The surgery is done with a permanent synthetic (man-made) mesh. The mesh is attached t
|
|---|---|---|---|
|
Change From Baseline PISQ-IR Sexually Active Average Score
06 Months
|
0.4 units on a scale
Interval 0.2 to 0.5
|
0.4 units on a scale
Interval 0.2 to 0.6
|
0.5 units on a scale
Interval 0.4 to 0.7
|
|
Change From Baseline PISQ-IR Sexually Active Average Score
12 Months
|
0.4 units on a scale
Interval 0.2 to 0.6
|
0.4 units on a scale
Interval 0.2 to 0.7
|
0.6 units on a scale
Interval 0.5 to 0.8
|
|
Change From Baseline PISQ-IR Sexually Active Average Score
24 Months
|
0.4 units on a scale
Interval 0.2 to 0.6
|
0.4 units on a scale
Interval 0.2 to 0.7
|
0.5 units on a scale
Interval 0.3 to 0.7
|
|
Change From Baseline PISQ-IR Sexually Active Average Score
36 Months
|
0.4 units on a scale
Interval 0.1 to 0.6
|
0.4 units on a scale
Interval 0.1 to 0.7
|
0.6 units on a scale
Interval 0.4 to 0.8
|
|
Change From Baseline PISQ-IR Sexually Active Average Score
48 Months
|
0.3 units on a scale
Interval 0.1 to 0.5
|
0.3 units on a scale
Interval 0.1 to 0.6
|
0.4 units on a scale
Interval 0.2 to 0.7
|
|
Change From Baseline PISQ-IR Sexually Active Average Score
60 Months
|
0.2 units on a scale
Interval 0.0 to 0.5
|
0.6 units on a scale
Interval 0.0 to 1.1
|
0.3 units on a scale
Interval 0.0 to 0.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months through 60 MonthsPopulation: An modified intent-to-treat (ITT) analysis which included all eligible participants who were randomized, received the randomized procedure, and who provided outcome data after baseline was performed.
POPQ Point Ba represents the most distal (i.e. most dependent) position of any part of the upper anterior vaginal wall (between the vaginal cuff or anterior vaginal fornix and Point Aa). Point Ba coincides with Point Aa (-3 cm) in a woman who has no anterior POP. In a woman with severe POP, Ba coincides with Point C.
Outcome measures
| Measure |
Native Tissue
n=117 Participants
Transvaginal Native Tissue Repair: Transvaginal Native Tissue Repair is a surgery performed with an incision through the vagina (transvaginal). The surgery is done using both permanent and absorbable
|
Sacral Colpopexy
n=118 Participants
Open, Robotic, or Laparoscopic: Sacral Colpopexy is a surgery performed either through an incision in the abdomen or through several small incisions with the help of a laparoscope (a slender tube) or
|
Transvaginal Mesh
n=110 Participants
Uphold� LITE: Transvaginal Mesh Repair is a surgery performed with an incision through the vagina (transvaginal). The surgery is done with a permanent synthetic (man-made) mesh. The mesh is attached t
|
|---|---|---|---|
|
Change From Baseline POP-Q Ba Measurement
06 Months
|
-3.9 cm
Interval -4.3 to -3.4
|
-4.5 cm
Interval -4.9 to -4.1
|
-4.6 cm
Interval -5.1 to -4.2
|
|
Change From Baseline POP-Q Ba Measurement
12 Months
|
-3.7 cm
Interval -4.2 to -3.3
|
-4.5 cm
Interval -4.9 to -4.1
|
-4.3 cm
Interval -4.8 to -3.8
|
|
Change From Baseline POP-Q Ba Measurement
18 Months
|
-3.7 cm
Interval -4.2 to -3.2
|
-4.5 cm
Interval -4.9 to -4.0
|
-4.5 cm
Interval -5.0 to -3.9
|
|
Change From Baseline POP-Q Ba Measurement
24 Months
|
-3.8 cm
Interval -4.3 to -3.3
|
-4.3 cm
Interval -4.7 to -3.8
|
-4.4 cm
Interval -4.9 to -3.9
|
|
Change From Baseline POP-Q Ba Measurement
30 Months
|
-3.6 cm
Interval -4.1 to -3.1
|
-4.6 cm
Interval -5.0 to -4.1
|
-4.2 cm
Interval -4.8 to -3.7
|
|
Change From Baseline POP-Q Ba Measurement
36 Months
|
-3.5 cm
Interval -4.0 to -3.0
|
-4.6 cm
Interval -5.2 to -4.1
|
-4.4 cm
Interval -5.0 to -3.9
|
|
Change From Baseline POP-Q Ba Measurement
42 Months
|
-3.7 cm
Interval -4.3 to -3.0
|
-4.4 cm
Interval -5.0 to -3.8
|
-4.3 cm
Interval -4.9 to -3.7
|
|
Change From Baseline POP-Q Ba Measurement
48 Months
|
-3.7 cm
Interval -4.3 to -3.1
|
-4.6 cm
Interval -5.3 to -3.9
|
-4.4 cm
Interval -5.1 to -3.7
|
|
Change From Baseline POP-Q Ba Measurement
54 Months
|
-3.5 cm
Interval -4.2 to -2.7
|
-4.5 cm
Interval -5.2 to -3.8
|
-4.4 cm
Interval -5.3 to -3.5
|
|
Change From Baseline POP-Q Ba Measurement
60 Months
|
-3.8 cm
Interval -4.6 to -3.0
|
-4.3 cm
Interval -5.0 to -3.7
|
-3.6 cm
Interval -4.6 to -2.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months through 60 MonthsPopulation: An modified intent-to-treat (ITT) analysis which included all eligible participants who were randomized, received the randomized procedure, and who provided outcome data after baseline was performed.
POP-Q Point Bp represents the most distal position of any part of the upper posterior vaginal wall (between the vaginal cuff or posterior vaginal fornix and Point Ap).
Outcome measures
| Measure |
Native Tissue
n=117 Participants
Transvaginal Native Tissue Repair: Transvaginal Native Tissue Repair is a surgery performed with an incision through the vagina (transvaginal). The surgery is done using both permanent and absorbable
|
Sacral Colpopexy
n=118 Participants
Open, Robotic, or Laparoscopic: Sacral Colpopexy is a surgery performed either through an incision in the abdomen or through several small incisions with the help of a laparoscope (a slender tube) or
|
Transvaginal Mesh
n=110 Participants
Uphold� LITE: Transvaginal Mesh Repair is a surgery performed with an incision through the vagina (transvaginal). The surgery is done with a permanent synthetic (man-made) mesh. The mesh is attached t
|
|---|---|---|---|
|
Change From Baseline POP-Q Bp Measurement
24 Months
|
-2.5 cm
Interval -3.2 to -1.9
|
-2.5 cm
Interval -3.1 to -1.8
|
-2.9 cm
Interval -3.5 to -2.2
|
|
Change From Baseline POP-Q Bp Measurement
30 Months
|
-2.8 cm
Interval -3.5 to -2.1
|
-2.5 cm
Interval -3.2 to -1.9
|
-2.8 cm
Interval -3.5 to -2.1
|
|
Change From Baseline POP-Q Bp Measurement
12 Months
|
-2.6 cm
Interval -3.2 to -2.0
|
-2.9 cm
Interval -3.5 to -2.3
|
-3 cm
Interval -3.5 to -2.4
|
|
Change From Baseline POP-Q Bp Measurement
18 Months
|
-2.4 cm
Interval -3.0 to -1.7
|
-2.8 cm
Interval -3.5 to -2.2
|
-3.1 cm
Interval -3.8 to -2.4
|
|
Change From Baseline POP-Q Bp Measurement
06 Months
|
-2.6 cm
Interval -3.2 to -2.0
|
-2.8 cm
Interval -3.3 to -2.2
|
-3.2 cm
Interval -3.7 to -2.6
|
|
Change From Baseline POP-Q Bp Measurement
36 Months
|
-2.3 cm
Interval -3.0 to -1.7
|
-2.5 cm
Interval -3.2 to -1.8
|
-2.8 cm
Interval -3.5 to -2.2
|
|
Change From Baseline POP-Q Bp Measurement
42 Months
|
-2.1 cm
Interval -2.9 to -1.3
|
-2.8 cm
Interval -3.5 to -2.0
|
-3 cm
Interval -3.8 to -2.3
|
|
Change From Baseline POP-Q Bp Measurement
48 Months
|
-2.6 cm
Interval -3.5 to -1.8
|
-2.6 cm
Interval -3.4 to -1.8
|
-3.4 cm
Interval -4.2 to -2.6
|
|
Change From Baseline POP-Q Bp Measurement
54 Months
|
-2.7 cm
Interval -3.7 to -1.7
|
-2.5 cm
Interval -3.5 to -1.5
|
-3.1 cm
Interval -4.0 to -2.2
|
|
Change From Baseline POP-Q Bp Measurement
60 Months
|
-2.6 cm
Interval -3.8 to -1.5
|
-2.3 cm
Interval -3.3 to -1.3
|
-3.1 cm
Interval -4.1 to -2.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months through 60 MonthsPopulation: An modified intent-to-treat (ITT) analysis which included all eligible participants who were randomized, received the randomized procedure, and who provided outcome data after baseline was performed.
POP-Q Point C is measured in cm relative to the hymen with negative values being proximal to the hymen and positive values distal to the hymen. Point C represents either the most distal edge of the cervix or the leading edge of the vaginal cuff after total hysterectomy.
Outcome measures
| Measure |
Native Tissue
n=117 Participants
Transvaginal Native Tissue Repair: Transvaginal Native Tissue Repair is a surgery performed with an incision through the vagina (transvaginal). The surgery is done using both permanent and absorbable
|
Sacral Colpopexy
n=118 Participants
Open, Robotic, or Laparoscopic: Sacral Colpopexy is a surgery performed either through an incision in the abdomen or through several small incisions with the help of a laparoscope (a slender tube) or
|
Transvaginal Mesh
n=110 Participants
Uphold� LITE: Transvaginal Mesh Repair is a surgery performed with an incision through the vagina (transvaginal). The surgery is done with a permanent synthetic (man-made) mesh. The mesh is attached t
|
|---|---|---|---|
|
Change From Baseline POP-Q C Measurement
06 Months
|
-5.1 cm
Interval -5.8 to -4.3
|
-6.9 cm
Interval -7.6 to -6.3
|
-6.1 cm
Interval -6.8 to -5.3
|
|
Change From Baseline POP-Q C Measurement
12 Months
|
-5.1 cm
Interval -5.8 to -4.4
|
-6.8 cm
Interval -7.6 to -6.1
|
-5.8 cm
Interval -6.5 to -5.1
|
|
Change From Baseline POP-Q C Measurement
18 Months
|
-4.9 cm
Interval -5.7 to -4.2
|
-6.8 cm
Interval -7.5 to -6.1
|
-5.9 cm
Interval -6.7 to -5.0
|
|
Change From Baseline POP-Q C Measurement
24 Months
|
-5 cm
Interval -5.8 to -4.2
|
-6.5 cm
Interval -7.2 to -5.8
|
-5.7 cm
Interval -6.4 to -4.9
|
|
Change From Baseline POP-Q C Measurement
30 Months
|
-4.7 cm
Interval -5.5 to -3.9
|
-7.1 cm
Interval -7.8 to -6.3
|
-5.4 cm
Interval -6.2 to -4.6
|
|
Change From Baseline POP-Q C Measurement
36 Months
|
-4.6 cm
Interval -5.4 to -3.9
|
-7.1 cm
Interval -7.9 to -6.3
|
-5.7 cm
Interval -6.5 to -4.9
|
|
Change From Baseline POP-Q C Measurement
42 Months
|
-4.5 cm
Interval -5.4 to -3.5
|
-7 cm
Interval -7.9 to -6.1
|
-5.6 cm
Interval -6.6 to -4.7
|
|
Change From Baseline POP-Q C Measurement
48 Months
|
-4.5 cm
Interval -5.5 to -3.6
|
-6.4 cm
Interval -7.4 to -5.4
|
-6.1 cm
Interval -7.2 to -5.0
|
|
Change From Baseline POP-Q C Measurement
54 Months
|
-4.5 cm
Interval -5.7 to -3.3
|
-6.6 cm
Interval -7.9 to -5.4
|
-5.8 cm
Interval -7.1 to -4.6
|
|
Change From Baseline POP-Q C Measurement
60 Months
|
-5.2 cm
Interval -6.5 to -3.9
|
-6.5 cm
Interval -7.5 to -5.4
|
-5.5 cm
Interval -6.6 to -4.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months through 60 MonthsPopulation: An modified intent-to-treat (ITT) analysis which included all eligible participants who were randomized, received the randomized procedure, and who provided outcome data after baseline was performed.
POP-Q Total Vaginal Length (TVL) is measured in cm. It is the length of the vagina from posterior fornix to the hymen when Point C or D is reduced to its full normal position.
Outcome measures
| Measure |
Native Tissue
n=117 Participants
Transvaginal Native Tissue Repair: Transvaginal Native Tissue Repair is a surgery performed with an incision through the vagina (transvaginal). The surgery is done using both permanent and absorbable
|
Sacral Colpopexy
n=118 Participants
Open, Robotic, or Laparoscopic: Sacral Colpopexy is a surgery performed either through an incision in the abdomen or through several small incisions with the help of a laparoscope (a slender tube) or
|
Transvaginal Mesh
n=110 Participants
Uphold� LITE: Transvaginal Mesh Repair is a surgery performed with an incision through the vagina (transvaginal). The surgery is done with a permanent synthetic (man-made) mesh. The mesh is attached t
|
|---|---|---|---|
|
Change From Baseline POP-Q TVL Measurement
06 Months
|
-0.9 cm
Interval -1.1 to -0.7
|
0.1 cm
Interval -0.2 to 0.4
|
-0.9 cm
Interval -1.2 to -0.6
|
|
Change From Baseline POP-Q TVL Measurement
12 Months
|
-1 cm
Interval -1.3 to -0.8
|
0 cm
Interval -0.3 to 0.3
|
-0.8 cm
Interval -1.1 to -0.6
|
|
Change From Baseline POP-Q TVL Measurement
18 Months
|
-1.1 cm
Interval -1.4 to -0.8
|
0 cm
Interval -0.3 to 0.3
|
-0.9 cm
Interval -1.2 to -0.6
|
|
Change From Baseline POP-Q TVL Measurement
24 Months
|
-0.9 cm
Interval -1.2 to -0.7
|
0 cm
Interval -0.4 to 0.3
|
-0.9 cm
Interval -1.3 to -0.6
|
|
Change From Baseline POP-Q TVL Measurement
30 Months
|
-1.2 cm
Interval -1.5 to -0.9
|
0.2 cm
Interval -0.1 to 0.6
|
-0.9 cm
Interval -1.2 to -0.6
|
|
Change From Baseline POP-Q TVL Measurement
36 Months
|
-0.9 cm
Interval -1.2 to -0.6
|
0.2 cm
Interval -0.1 to 0.5
|
-1 cm
Interval -1.3 to -0.7
|
|
Change From Baseline POP-Q TVL Measurement
42 Months
|
-1 cm
Interval -1.3 to -0.6
|
-0.1 cm
Interval -0.4 to 0.3
|
-1.1 cm
Interval -1.5 to -0.7
|
|
Change From Baseline POP-Q TVL Measurement
48 Months
|
-1.1 cm
Interval -1.5 to -0.7
|
0 cm
Interval -0.5 to 0.5
|
-0.8 cm
Interval -1.2 to -0.5
|
|
Change From Baseline POP-Q TVL Measurement
54 Months
|
-1 cm
Interval -1.5 to -0.4
|
-0.1 cm
Interval -0.8 to 0.5
|
-0.9 cm
Interval -1.3 to -0.4
|
|
Change From Baseline POP-Q TVL Measurement
60 Months
|
-0.8 cm
Interval -1.2 to -0.3
|
-0.3 cm
Interval -0.8 to 0.2
|
-0.8 cm
Interval -1.3 to -0.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months through 60 MonthsPopulation: An modified intent-to-treat (ITT) analysis which included all eligible participants who were randomized, received the randomized procedure, and who provided outcome data after baseline was performed.
The Patient Global Impression of Improvement (PGI-I) is a patient-reported measure of perceived improvement with treatment, as assessed on a scale of 1 (very much better) to 7 (very much worse). Included here are participants who had improvement as indicated by a rating of 1 (very much better), 2 (much better).
Outcome measures
| Measure |
Native Tissue
n=116 Participants
Transvaginal Native Tissue Repair: Transvaginal Native Tissue Repair is a surgery performed with an incision through the vagina (transvaginal). The surgery is done using both permanent and absorbable
|
Sacral Colpopexy
n=118 Participants
Open, Robotic, or Laparoscopic: Sacral Colpopexy is a surgery performed either through an incision in the abdomen or through several small incisions with the help of a laparoscope (a slender tube) or
|
Transvaginal Mesh
n=112 Participants
Uphold� LITE: Transvaginal Mesh Repair is a surgery performed with an incision through the vagina (transvaginal). The surgery is done with a permanent synthetic (man-made) mesh. The mesh is attached t
|
|---|---|---|---|
|
Number of Participants With PGI-I Reported Improvement
06 Months · Improvement
|
96 Participants
|
108 Participants
|
98 Participants
|
|
Number of Participants With PGI-I Reported Improvement
06 Months · No improvement
|
16 Participants
|
6 Participants
|
11 Participants
|
|
Number of Participants With PGI-I Reported Improvement
12 Months · Improvement
|
101 Participants
|
100 Participants
|
96 Participants
|
|
Number of Participants With PGI-I Reported Improvement
12 Months · No improvement
|
9 Participants
|
8 Participants
|
8 Participants
|
|
Number of Participants With PGI-I Reported Improvement
24 Months · Improvement
|
87 Participants
|
90 Participants
|
97 Participants
|
|
Number of Participants With PGI-I Reported Improvement
24 Months · No improvement
|
10 Participants
|
5 Participants
|
7 Participants
|
|
Number of Participants With PGI-I Reported Improvement
36 Months · Improvement
|
79 Participants
|
88 Participants
|
84 Participants
|
|
Number of Participants With PGI-I Reported Improvement
36 Months · No improvement
|
12 Participants
|
5 Participants
|
5 Participants
|
|
Number of Participants With PGI-I Reported Improvement
48 Months · Improvement
|
58 Participants
|
68 Participants
|
67 Participants
|
|
Number of Participants With PGI-I Reported Improvement
48 Months · No improvement
|
15 Participants
|
4 Participants
|
6 Participants
|
|
Number of Participants With PGI-I Reported Improvement
60 Months · Improvement
|
33 Participants
|
33 Participants
|
34 Participants
|
|
Number of Participants With PGI-I Reported Improvement
60 Months · No improvement
|
8 Participants
|
4 Participants
|
3 Participants
|
Adverse Events
Native Tissue
Serious events: 14 serious events
Other events: 100 other events
Deaths: 2 deaths
Sacral Colpopexy
Serious events: 24 serious events
Other events: 88 other events
Deaths: 1 deaths
Transvaginal Mesh
Serious events: 25 serious events
Other events: 91 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Native Tissue
n=123 participants at risk
Transvaginal Native Tissue Repair: Transvaginal Native Tissue Repair is a surgery performed with an incision through the vagina (transvaginal). The surgery is done using both permanent and absorbable
|
Sacral Colpopexy
n=121 participants at risk
Open, Robotic, or Laparoscopic: Sacral Colpopexy is a surgery performed either through an incision in the abdomen or through several small incisions with the help of a laparoscope (a slender tube) or
|
Transvaginal Mesh
n=116 participants at risk
Uphold� LITE: Transvaginal Mesh Repair is a surgery performed with an incision through the vagina (transvaginal). The surgery is done with a permanent synthetic (man-made) mesh. The mesh is attached t
|
|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/123 • 60 Months
|
0.83%
1/121 • Number of events 1 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/123 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
Cardiac disorders
Cardiac failure congestive
|
0.81%
1/123 • Number of events 1 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.81%
1/123 • Number of events 1 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/123 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.00%
0/123 • 60 Months
|
0.83%
1/121 • Number of events 1 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/123 • 60 Months
|
0.83%
1/121 • Number of events 1 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/123 • 60 Months
|
0.83%
1/121 • Number of events 1 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/123 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
Gastrointestinal disorders
Colitis microscopic
|
0.00%
0/123 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.86%
1/116 • Number of events 2 • 60 Months
|
|
Gastrointestinal disorders
Constipation
|
1.6%
2/123 • Number of events 3 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/123 • 60 Months
|
0.83%
1/121 • Number of events 2 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Gastrointestinal disorders
Levator syndrome
|
0.00%
0/123 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.86%
1/116 • Number of events 4 • 60 Months
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/123 • 60 Months
|
1.7%
2/121 • Number of events 6 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.00%
0/123 • 60 Months
|
0.83%
1/121 • Number of events 1 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
General disorders
Death
|
0.00%
0/123 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
Infections and infestations
Appendicitis
|
0.00%
0/123 • 60 Months
|
0.83%
1/121 • Number of events 1 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Infections and infestations
Creutzfeldt-Jakob disease
|
0.00%
0/123 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
Infections and infestations
Diverticulitis
|
0.81%
1/123 • Number of events 1 • 60 Months
|
1.7%
2/121 • Number of events 2 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Infections and infestations
Pneumonia
|
0.00%
0/123 • 60 Months
|
1.7%
2/121 • Number of events 2 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Infections and infestations
Pyelonephritis
|
0.81%
1/123 • Number of events 1 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Infections and infestations
Sepsis
|
0.00%
0/123 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/123 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
Injury, poisoning and procedural complications
Bladder injury
|
4.1%
5/123 • Number of events 7 • 60 Months
|
4.1%
5/121 • Number of events 6 • 60 Months
|
3.4%
4/116 • Number of events 5 • 60 Months
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/123 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/123 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
Injury, poisoning and procedural complications
Incision site haemorrhage
|
0.00%
0/123 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/123 • 60 Months
|
0.83%
1/121 • Number of events 1 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.00%
0/123 • 60 Months
|
0.83%
1/121 • Number of events 1 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.81%
1/123 • Number of events 2 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Injury, poisoning and procedural complications
Rectal injury
|
0.81%
1/123 • Number of events 1 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
Injury, poisoning and procedural complications
Ureteric injury
|
0.00%
0/123 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/123 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/123 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/123 • 60 Months
|
0.83%
1/121 • Number of events 1 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/123 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.00%
0/123 • 60 Months
|
0.83%
1/121 • Number of events 1 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal cancer metastatic
|
0.81%
1/123 • Number of events 1 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis
|
0.00%
0/123 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/123 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
Nervous system disorders
Syncope
|
0.00%
0/123 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/123 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/123 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.86%
1/116 • Number of events 2 • 60 Months
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/123 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
Renal and urinary disorders
Renal mass
|
0.81%
1/123 • Number of events 1 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.81%
1/123 • Number of events 1 • 60 Months
|
2.5%
3/121 • Number of events 3 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Renal and urinary disorders
Urinary retention
|
0.81%
1/123 • Number of events 1 • 60 Months
|
0.00%
0/121 • 60 Months
|
1.7%
2/116 • Number of events 2 • 60 Months
|
|
Reproductive system and breast disorders
Pelvic haematoma
|
0.81%
1/123 • Number of events 1 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/123 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/123 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
Surgical and medical procedures
Bladder neck suspension
|
0.81%
1/123 • Number of events 1 • 60 Months
|
1.7%
2/121 • Number of events 2 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.00%
0/123 • 60 Months
|
0.83%
1/121 • Number of events 1 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Surgical and medical procedures
Hospitalisation
|
1.6%
2/123 • Number of events 2 • 60 Months
|
0.83%
1/121 • Number of events 1 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
Surgical and medical procedures
Intra-thoracic aortic aneurysm repair
|
0.00%
0/123 • 60 Months
|
0.83%
1/121 • Number of events 1 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Surgical and medical procedures
Thyroidectomy
|
0.00%
0/123 • 60 Months
|
0.83%
1/121 • Number of events 1 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Surgical and medical procedures
Vaginal prolapse repair
|
0.00%
0/123 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
Vascular disorders
Thrombophlebitis
|
0.81%
1/123 • Number of events 1 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.00%
0/116 • 60 Months
|
Other adverse events
| Measure |
Native Tissue
n=123 participants at risk
Transvaginal Native Tissue Repair: Transvaginal Native Tissue Repair is a surgery performed with an incision through the vagina (transvaginal). The surgery is done using both permanent and absorbable
|
Sacral Colpopexy
n=121 participants at risk
Open, Robotic, or Laparoscopic: Sacral Colpopexy is a surgery performed either through an incision in the abdomen or through several small incisions with the help of a laparoscope (a slender tube) or
|
Transvaginal Mesh
n=116 participants at risk
Uphold� LITE: Transvaginal Mesh Repair is a surgery performed with an incision through the vagina (transvaginal). The surgery is done with a permanent synthetic (man-made) mesh. The mesh is attached t
|
|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/123 • 60 Months
|
0.00%
0/121 • 60 Months
|
1.7%
2/116 • Number of events 3 • 60 Months
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/123 • 60 Months
|
0.83%
1/121 • Number of events 1 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
Eye disorders
Eye swelling
|
0.00%
0/123 • 60 Months
|
0.83%
1/121 • Number of events 1 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/123 • 60 Months
|
1.7%
2/121 • Number of events 2 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/123 • 60 Months
|
0.83%
1/121 • Number of events 1 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Gastrointestinal disorders
Constipation
|
4.9%
6/123 • Number of events 7 • 60 Months
|
8.3%
10/121 • Number of events 11 • 60 Months
|
5.2%
6/116 • Number of events 6 • 60 Months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/123 • 60 Months
|
0.00%
0/121 • 60 Months
|
1.7%
2/116 • Number of events 2 • 60 Months
|
|
Gastrointestinal disorders
Faecal incontinence
|
10.6%
13/123 • Number of events 13 • 60 Months
|
7.4%
9/121 • Number of events 9 • 60 Months
|
10.3%
12/116 • Number of events 12 • 60 Months
|
|
Gastrointestinal disorders
Faecaloma
|
0.81%
1/123 • Number of events 1 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.81%
1/123 • Number of events 1 • 60 Months
|
0.00%
0/121 • 60 Months
|
2.6%
3/116 • Number of events 3 • 60 Months
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/123 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
Gastrointestinal disorders
Intestinal cyst
|
0.81%
1/123 • Number of events 1 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Gastrointestinal disorders
Levator syndrome
|
0.81%
1/123 • Number of events 1 • 60 Months
|
1.7%
2/121 • Number of events 2 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/123 • 60 Months
|
0.83%
1/121 • Number of events 2 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Gastrointestinal disorders
Painful defaecation
|
0.81%
1/123 • Number of events 1 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Gastrointestinal disorders
Proctalgia
|
0.81%
1/123 • Number of events 1 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Gastrointestinal disorders
Rectal prolapse
|
0.00%
0/123 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
General disorders
Adhesion
|
0.00%
0/123 • 60 Months
|
0.83%
1/121 • Number of events 1 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
General disorders
Asthenia
|
0.81%
1/123 • Number of events 2 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
General disorders
Chest pain
|
0.00%
0/123 • 60 Months
|
0.83%
1/121 • Number of events 1 • 60 Months
|
1.7%
2/116 • Number of events 2 • 60 Months
|
|
General disorders
Device malfunction
|
0.81%
1/123 • Number of events 1 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
General disorders
Fatigue
|
0.81%
1/123 • Number of events 1 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
General disorders
Granuloma
|
0.00%
0/123 • 60 Months
|
0.83%
1/121 • Number of events 1 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
General disorders
Hypothermia
|
0.00%
0/123 • 60 Months
|
0.83%
1/121 • Number of events 1 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
General disorders
Medical device site pain
|
0.00%
0/123 • 60 Months
|
0.83%
1/121 • Number of events 1 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
General disorders
Medical device site reaction
|
8.9%
11/123 • Number of events 12 • 60 Months
|
4.1%
5/121 • Number of events 6 • 60 Months
|
6.9%
8/116 • Number of events 9 • 60 Months
|
|
General disorders
Pyrexia
|
0.00%
0/123 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/123 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
Immune system disorders
Hypersensitivity
|
0.81%
1/123 • Number of events 1 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Infections and infestations
Bacterial vaginosis
|
0.00%
0/123 • 60 Months
|
0.83%
1/121 • Number of events 1 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
Infections and infestations
Bartholin's abscess
|
0.81%
1/123 • Number of events 1 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Infections and infestations
Bronchitis
|
1.6%
2/123 • Number of events 2 • 60 Months
|
0.83%
1/121 • Number of events 1 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Infections and infestations
Cellulitis
|
0.81%
1/123 • Number of events 1 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Infections and infestations
Conjunctivitis
|
0.81%
1/123 • Number of events 1 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Infections and infestations
Cystitis
|
0.81%
1/123 • Number of events 1 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Infections and infestations
Diverticulitis
|
0.81%
1/123 • Number of events 1 • 60 Months
|
0.83%
1/121 • Number of events 1 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
Infections and infestations
Fungal infection
|
0.81%
1/123 • Number of events 1 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
Infections and infestations
Herpes zoster
|
0.81%
1/123 • Number of events 1 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Infections and infestations
Pneumonia
|
0.00%
0/123 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
Infections and infestations
Pyelonephritis
|
1.6%
2/123 • Number of events 2 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Infections and infestations
Sinusitis
|
0.00%
0/123 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
Infections and infestations
Subcutaneous abscess
|
0.81%
1/123 • Number of events 1 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Infections and infestations
Urinary tract infection
|
47.2%
58/123 • Number of events 93 • 60 Months
|
28.9%
35/121 • Number of events 51 • 60 Months
|
51.7%
60/116 • Number of events 93 • 60 Months
|
|
Infections and infestations
Vaginal infection
|
4.1%
5/123 • Number of events 6 • 60 Months
|
3.3%
4/121 • Number of events 4 • 60 Months
|
9.5%
11/116 • Number of events 13 • 60 Months
|
|
Infections and infestations
Vulvitis
|
0.00%
0/123 • 60 Months
|
0.83%
1/121 • Number of events 1 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/123 • 60 Months
|
0.83%
1/121 • Number of events 1 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Infections and infestations
Vulvovaginitis
|
0.00%
0/123 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
Infections and infestations
Wound infection
|
0.81%
1/123 • Number of events 1 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Injury, poisoning and procedural complications
Back injury
|
0.81%
1/123 • Number of events 1 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Injury, poisoning and procedural complications
Bladder injury
|
0.00%
0/123 • 60 Months
|
0.83%
1/121 • Number of events 1 • 60 Months
|
1.7%
2/116 • Number of events 2 • 60 Months
|
|
Injury, poisoning and procedural complications
Fall
|
0.81%
1/123 • Number of events 1 • 60 Months
|
0.00%
0/121 • 60 Months
|
1.7%
2/116 • Number of events 2 • 60 Months
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/123 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
Injury, poisoning and procedural complications
Incision site pain
|
0.00%
0/123 • 60 Months
|
1.7%
2/121 • Number of events 2 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/123 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.81%
1/123 • Number of events 1 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Injury, poisoning and procedural complications
Postoperative fever
|
0.81%
1/123 • Number of events 1 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
0.81%
1/123 • Number of events 1 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.00%
0/123 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/123 • 60 Months
|
0.83%
1/121 • Number of events 2 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
Injury, poisoning and procedural complications
Procedural vomiting
|
0.81%
1/123 • Number of events 1 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
Injury, poisoning and procedural complications
Suture related complication
|
0.81%
1/123 • Number of events 1 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Injury, poisoning and procedural complications
Urinary retention postoperative
|
0.81%
1/123 • Number of events 1 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Injury, poisoning and procedural complications
Vaginal laceration
|
0.00%
0/123 • 60 Months
|
0.83%
1/121 • Number of events 1 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Investigations
Culture urine
|
0.00%
0/123 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
Investigations
Endoscopy upper gastrointestinal tract
|
0.00%
0/123 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.86%
1/116 • Number of events 2 • 60 Months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/123 • 60 Months
|
0.83%
1/121 • Number of events 1 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/123 • 60 Months
|
1.7%
2/121 • Number of events 2 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/123 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
0.81%
1/123 • Number of events 1 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/123 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/123 • 60 Months
|
0.83%
1/121 • Number of events 1 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.81%
1/123 • Number of events 1 • 60 Months
|
0.00%
0/121 • 60 Months
|
1.7%
2/116 • Number of events 2 • 60 Months
|
|
Musculoskeletal and connective tissue disorders
Osteitis deformans
|
0.00%
0/123 • 60 Months
|
0.83%
1/121 • Number of events 1 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.81%
1/123 • Number of events 1 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/123 • 60 Months
|
0.00%
0/121 • 60 Months
|
1.7%
2/116 • Number of events 2 • 60 Months
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/123 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vulval cancer
|
0.81%
1/123 • Number of events 1 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Nervous system disorders
Dizziness
|
0.81%
1/123 • Number of events 1 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Nervous system disorders
Headache
|
0.00%
0/123 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
Nervous system disorders
Hypoaesthesia
|
0.81%
1/123 • Number of events 1 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Nervous system disorders
Migraine
|
0.00%
0/123 • 60 Months
|
1.7%
2/121 • Number of events 2 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/123 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
Nervous system disorders
Neuromyopathy
|
0.00%
0/123 • 60 Months
|
1.7%
2/121 • Number of events 2 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Nervous system disorders
Piriformis syndrome
|
0.00%
0/123 • 60 Months
|
0.83%
1/121 • Number of events 1 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/123 • 60 Months
|
0.83%
1/121 • Number of events 1 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Nervous system disorders
Sciatica
|
0.00%
0/123 • 60 Months
|
0.00%
0/121 • 60 Months
|
1.7%
2/116 • Number of events 2 • 60 Months
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/123 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
Psychiatric disorders
Confusional state
|
0.81%
1/123 • Number of events 1 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Psychiatric disorders
Depression
|
0.00%
0/123 • 60 Months
|
0.83%
1/121 • Number of events 1 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/123 • 60 Months
|
0.83%
1/121 • Number of events 1 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Renal and urinary disorders
Bladder dysfunction
|
0.00%
0/123 • 60 Months
|
0.83%
1/121 • Number of events 1 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Renal and urinary disorders
Calculus bladder
|
0.81%
1/123 • Number of events 1 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Renal and urinary disorders
Dysuria
|
0.81%
1/123 • Number of events 1 • 60 Months
|
1.7%
2/121 • Number of events 2 • 60 Months
|
0.86%
1/116 • Number of events 2 • 60 Months
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/123 • 60 Months
|
0.83%
1/121 • Number of events 1 • 60 Months
|
1.7%
2/116 • Number of events 2 • 60 Months
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/123 • 60 Months
|
0.83%
1/121 • Number of events 1 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Renal and urinary disorders
Hydroureter
|
0.00%
0/123 • 60 Months
|
0.83%
1/121 • Number of events 1 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Renal and urinary disorders
Hypertonic bladder
|
1.6%
2/123 • Number of events 2 • 60 Months
|
0.83%
1/121 • Number of events 1 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/123 • 60 Months
|
0.83%
1/121 • Number of events 1 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/123 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
Renal and urinary disorders
Nocturia
|
0.81%
1/123 • Number of events 1 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Renal and urinary disorders
Obstructive uropathy
|
0.81%
1/123 • Number of events 1 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Renal and urinary disorders
Pelvi-ureteric obstruction
|
0.81%
1/123 • Number of events 1 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/123 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
Renal and urinary disorders
Stress urinary incontinence
|
8.1%
10/123 • Number of events 10 • 60 Months
|
18.2%
22/121 • Number of events 22 • 60 Months
|
14.7%
17/116 • Number of events 18 • 60 Months
|
|
Renal and urinary disorders
Urethral caruncle
|
0.00%
0/123 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
Renal and urinary disorders
Urge incontinence
|
24.4%
30/123 • Number of events 32 • 60 Months
|
28.1%
34/121 • Number of events 35 • 60 Months
|
20.7%
24/116 • Number of events 27 • 60 Months
|
|
Renal and urinary disorders
Urinary incontinence
|
0.81%
1/123 • Number of events 1 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
Renal and urinary disorders
Urinary retention
|
8.1%
10/123 • Number of events 11 • 60 Months
|
5.8%
7/121 • Number of events 7 • 60 Months
|
11.2%
13/116 • Number of events 16 • 60 Months
|
|
Renal and urinary disorders
Urine flow decreased
|
0.00%
0/123 • 60 Months
|
0.83%
1/121 • Number of events 1 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Reproductive system and breast disorders
Atrophic vulvovaginitis
|
0.81%
1/123 • Number of events 1 • 60 Months
|
1.7%
2/121 • Number of events 2 • 60 Months
|
5.2%
6/116 • Number of events 6 • 60 Months
|
|
Reproductive system and breast disorders
Bartholin's cyst
|
0.00%
0/123 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
Reproductive system and breast disorders
Cystocele
|
0.81%
1/123 • Number of events 1 • 60 Months
|
0.83%
1/121 • Number of events 1 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Reproductive system and breast disorders
Dyspareunia
|
6.5%
8/123 • Number of events 9 • 60 Months
|
5.0%
6/121 • Number of events 6 • 60 Months
|
4.3%
5/116 • Number of events 5 • 60 Months
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/123 • 60 Months
|
0.83%
1/121 • Number of events 1 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Reproductive system and breast disorders
Pelvic pain
|
4.9%
6/123 • Number of events 6 • 60 Months
|
6.6%
8/121 • Number of events 8 • 60 Months
|
4.3%
5/116 • Number of events 5 • 60 Months
|
|
Reproductive system and breast disorders
Perineal erythema
|
0.81%
1/123 • Number of events 1 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/123 • 60 Months
|
0.00%
0/121 • 60 Months
|
2.6%
3/116 • Number of events 3 • 60 Months
|
|
Reproductive system and breast disorders
Vaginal haematoma
|
0.00%
0/123 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
5.7%
7/123 • Number of events 7 • 60 Months
|
1.7%
2/121 • Number of events 2 • 60 Months
|
2.6%
3/116 • Number of events 3 • 60 Months
|
|
Reproductive system and breast disorders
Vaginal odour
|
0.00%
0/123 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
Reproductive system and breast disorders
Vaginal perforation
|
0.00%
0/123 • 60 Months
|
0.83%
1/121 • Number of events 1 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.00%
0/123 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
Reproductive system and breast disorders
Vulval disorder
|
0.00%
0/123 • 60 Months
|
0.83%
1/121 • Number of events 1 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Reproductive system and breast disorders
Vulval polyp
|
0.00%
0/123 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
Reproductive system and breast disorders
Vulvar erosion
|
0.00%
0/123 • 60 Months
|
0.83%
1/121 • Number of events 1 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Reproductive system and breast disorders
Vulvovaginal adhesion
|
0.81%
1/123 • Number of events 1 • 60 Months
|
0.83%
1/121 • Number of events 1 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
Reproductive system and breast disorders
Vulvovaginal discomfort
|
0.81%
1/123 • Number of events 1 • 60 Months
|
1.7%
2/121 • Number of events 2 • 60 Months
|
2.6%
3/116 • Number of events 3 • 60 Months
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
0.00%
0/123 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
Reproductive system and breast disorders
Vulvovaginal pain
|
0.81%
1/123 • Number of events 1 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
1.6%
2/123 • Number of events 2 • 60 Months
|
0.83%
1/121 • Number of events 1 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/123 • 60 Months
|
0.00%
0/121 • 60 Months
|
1.7%
2/116 • Number of events 2 • 60 Months
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.00%
0/123 • 60 Months
|
0.83%
1/121 • Number of events 1 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/123 • 60 Months
|
0.83%
1/121 • Number of events 1 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/123 • 60 Months
|
0.83%
1/121 • Number of events 1 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.81%
1/123 • Number of events 1 • 60 Months
|
0.83%
1/121 • Number of events 1 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Skin and subcutaneous tissue disorders
Excessive granulation tissue
|
13.0%
16/123 • Number of events 16 • 60 Months
|
1.7%
2/121 • Number of events 2 • 60 Months
|
6.0%
7/116 • Number of events 8 • 60 Months
|
|
Skin and subcutaneous tissue disorders
Lichen sclerosus
|
0.81%
1/123 • Number of events 1 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.81%
1/123 • Number of events 1 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/123 • 60 Months
|
1.7%
2/121 • Number of events 2 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/123 • 60 Months
|
0.83%
1/121 • Number of events 1 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.81%
1/123 • Number of events 1 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Surgical and medical procedures
Bladder neck suspension
|
0.81%
1/123 • Number of events 1 • 60 Months
|
2.5%
3/121 • Number of events 3 • 60 Months
|
1.7%
2/116 • Number of events 2 • 60 Months
|
|
Surgical and medical procedures
Cataract operation
|
0.00%
0/123 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.86%
1/116 • Number of events 2 • 60 Months
|
|
Surgical and medical procedures
Colporrhaphy
|
0.00%
0/123 • 60 Months
|
0.83%
1/121 • Number of events 1 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Surgical and medical procedures
Cystocele repair
|
0.00%
0/123 • 60 Months
|
0.83%
1/121 • Number of events 1 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Surgical and medical procedures
Emergency care
|
1.6%
2/123 • Number of events 2 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
Surgical and medical procedures
Laparotomy
|
0.00%
0/123 • 60 Months
|
0.83%
1/121 • Number of events 1 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Surgical and medical procedures
Office visit
|
2.4%
3/123 • Number of events 3 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
Surgical and medical procedures
Prolapse repair
|
0.81%
1/123 • Number of events 1 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Surgical and medical procedures
Stent placement
|
0.00%
0/123 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.86%
1/116 • Number of events 1 • 60 Months
|
|
Surgical and medical procedures
Surgery
|
0.00%
0/123 • 60 Months
|
0.83%
1/121 • Number of events 1 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Surgical and medical procedures
Urinary incontinence surgery
|
0.00%
0/123 • 60 Months
|
0.83%
1/121 • Number of events 1 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Surgical and medical procedures
Vaginal prolapse repair
|
2.4%
3/123 • Number of events 4 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Vascular disorders
Hot flush
|
0.00%
0/123 • 60 Months
|
1.7%
2/121 • Number of events 2 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Vascular disorders
Hypertension
|
0.00%
0/123 • 60 Months
|
0.83%
1/121 • Number of events 1 • 60 Months
|
0.00%
0/116 • 60 Months
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.81%
1/123 • Number of events 1 • 60 Months
|
0.00%
0/121 • 60 Months
|
0.00%
0/116 • 60 Months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place