Trial Outcomes & Findings for Study of Uterine Prolapse Procedures - Randomized Trial (NCT NCT01802281)
NCT ID: NCT01802281
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.
COMPLETED
NA
183 participants
6 Months through 36 Months
2025-08-26
Participant Flow
Participant milestones
| Measure |
Hysteropexy
Uphold® LITE
Uphold® LITE: The Uphold® procedure used in this protocol is a modification of the technique described by Vu and Goldberg.
|
Hysterectomy and USLS
Vaginal hysterectomy and uterosacral ligament suspension (USLS)
Uterosacral ligament suspension: The USLS procedure used in this protocol is a modification of the technique described by Shull.
|
|---|---|---|
|
Overall Study
STARTED
|
93
|
90
|
|
Overall Study
Eligible and Received Randomized Treatment
|
88
|
87
|
|
Overall Study
Completed Year 1 Follow-up
|
88
|
86
|
|
Overall Study
Completed Year 2 Follow-up
|
87
|
84
|
|
Overall Study
COMPLETED
|
85
|
84
|
|
Overall Study
NOT COMPLETED
|
8
|
6
|
Reasons for withdrawal
| Measure |
Hysteropexy
Uphold® LITE
Uphold® LITE: The Uphold® procedure used in this protocol is a modification of the technique described by Vu and Goldberg.
|
Hysterectomy and USLS
Vaginal hysterectomy and uterosacral ligament suspension (USLS)
Uterosacral ligament suspension: The USLS procedure used in this protocol is a modification of the technique described by Shull.
|
|---|---|---|
|
Overall Study
Death
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Ineligible
|
5
|
3
|
Baseline Characteristics
Study of Uterine Prolapse Procedures - Randomized Trial
Baseline characteristics by cohort
| Measure |
UPHOLD
n=88 Participants
UPHOLD Procedure
|
USLS
n=87 Participants
Vaginal hysterectomy and Uterosacral Ligament Suspension (USLS)
|
Total
n=175 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.5 years
STANDARD_DEVIATION 7 • n=5 Participants
|
66.2 years
STANDARD_DEVIATION 7 • n=7 Participants
|
65.9 years
STANDARD_DEVIATION 7 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
88 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
175 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaskan Native
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
73 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
150 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latina
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic/Not Latina
|
76 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
154 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown/Not Reported
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Marital Status
Divorced, separated
|
16 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Marital Status
Married/Living with partner
|
56 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
|
Marital Status
Single
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Marital Status
Widowed
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Education
4-year College Degree
|
16 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Education
Associate College Degree
|
22 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Education
Graduate Degree
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Education
High School/GED
|
31 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Education
Less than High School
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Education
Unknown/Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Body Mass Index
|
28.9 kg/m^2
STANDARD_DEVIATION 4.0 • n=5 Participants
|
28.2 kg/m^2
STANDARD_DEVIATION 4.4 • n=7 Participants
|
28.5 kg/m^2
STANDARD_DEVIATION 4.2 • n=5 Participants
|
|
Current Smoker
No
|
85 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
171 Participants
n=5 Participants
|
|
Current Smoker
Yes
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Number of Pregnancies
|
3 Number of pregnancies
n=5 Participants
|
3 Number of pregnancies
n=7 Participants
|
3 Number of pregnancies
n=5 Participants
|
|
Number of Vaginal Deliveries
|
3 Number of deliveries
n=5 Participants
|
2 Number of deliveries
n=7 Participants
|
3 Number of deliveries
n=5 Participants
|
|
Menstrual Status
pre-menopausal (includes peri-menopausal)/not sure
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Menstrual Status
post-menopausal (no menses for the last 12-months)
|
86 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
171 Participants
n=5 Participants
|
|
POP-Q Ba
|
3.3 cm
STANDARD_DEVIATION 2.0 • n=5 Participants
|
3 cm
STANDARD_DEVIATION 2.2 • n=7 Participants
|
3.1 cm
STANDARD_DEVIATION 2.1 • n=5 Participants
|
|
POP-Q Bp
|
0.4 cm
STANDARD_DEVIATION 3.0 • n=5 Participants
|
0.7 cm
STANDARD_DEVIATION 3.0 • n=7 Participants
|
0.6 cm
STANDARD_DEVIATION 3.0 • n=5 Participants
|
|
POP-Q C
|
0.4 cm
STANDARD_DEVIATION 3.5 • n=5 Participants
|
0.7 cm
STANDARD_DEVIATION 3.6 • n=7 Participants
|
0.5 cm
STANDARD_DEVIATION 3.5 • n=5 Participants
|
|
POP-Q TVL
|
9.1 cm
STANDARD_DEVIATION 1.1 • n=5 Participants
|
9.1 cm
STANDARD_DEVIATION 1.1 • n=7 Participants
|
9.1 cm
STANDARD_DEVIATION 1.1 • n=5 Participants
|
|
POP-Q Stage
2
|
15 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
POP-Q Stage
3
|
63 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
|
POP-Q Stage
4
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 Months through 36 MonthsPopulation: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and received the assigned treatment. Participants were included at each time point at which they provided outcome data after baseline.
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 |
UPHOLD
n=88 Participants
UPHOLD Procedure
|
USLS
n=87 Participants
Vaginal hysterectomy and Uterosacral Ligament Suspension (USLS)
|
|---|---|---|
|
Cumulative Failure
6 Months · Non-Failure
|
78 Participants
|
69 Participants
|
|
Cumulative Failure
6 Months · Failure
|
9 Participants
|
16 Participants
|
|
Cumulative Failure
12 Months · Non-Failure
|
71 Participants
|
63 Participants
|
|
Cumulative Failure
12 Months · Failure
|
15 Participants
|
22 Participants
|
|
Cumulative Failure
18 Months · Non-Failure
|
66 Participants
|
58 Participants
|
|
Cumulative Failure
18 Months · Failure
|
19 Participants
|
26 Participants
|
|
Cumulative Failure
24 Months · Non-Failure
|
59 Participants
|
54 Participants
|
|
Cumulative Failure
24 Months · Failure
|
21 Participants
|
29 Participants
|
|
Cumulative Failure
30 Months · Non-Failure
|
55 Participants
|
52 Participants
|
|
Cumulative Failure
30 Months · Failure
|
24 Participants
|
31 Participants
|
|
Cumulative Failure
36 Months · Non-Failure
|
53 Participants
|
47 Participants
|
|
Cumulative Failure
36 Months · Failure
|
26 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: 6 months through 36 MonthsPopulation: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and received the assigned treatment. Participants were included at each time point at which they provided outcome data after baseline.
Failure was defines 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 transient failure state assumption, the number of participants shown at each visit includes all participants who were still participating in the study. Similarly, the denominator number of participants for the transient failure at each visit includes all participants who were still participating in the study and attended the visit or who missed the visit but had a retreatment failure outcome prior to their missed visit.
Outcome measures
| Measure |
UPHOLD
n=88 Participants
UPHOLD Procedure
|
USLS
n=87 Participants
Vaginal hysterectomy and Uterosacral Ligament Suspension (USLS)
|
|---|---|---|
|
At-visit Failure
6 Months · Non-failure
|
78 Participants
|
69 Participants
|
|
At-visit Failure
6 Months · Failure
|
9 Participants
|
16 Participants
|
|
At-visit Failure
12 Months · Non-failure
|
74 Participants
|
65 Participants
|
|
At-visit Failure
36 Months · Failure
|
16 Participants
|
21 Participants
|
|
At-visit Failure
12 Months · Failure
|
12 Participants
|
19 Participants
|
|
At-visit Failure
18 Months · Non-failure
|
69 Participants
|
65 Participants
|
|
At-visit Failure
18 Months · Failure
|
15 Participants
|
18 Participants
|
|
At-visit Failure
24 Months · Non-failure
|
64 Participants
|
63 Participants
|
|
At-visit Failure
24 Months · Failure
|
15 Participants
|
17 Participants
|
|
At-visit Failure
30 Months · Non-failure
|
60 Participants
|
60 Participants
|
|
At-visit Failure
30 Months · Failure
|
18 Participants
|
18 Participants
|
|
At-visit Failure
36 Months · Non-failure
|
62 Participants
|
57 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6, 12, 18, 24, and 36 MonthsPopulation: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and received the assigned treatment. Participants were included at each time point at which they provided outcome data after baseline.
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 on the CRADI is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Scores are calculated by multiplying the mean value of all questions answered by 25 for the scale. The range of responses is: 0-100 with 0 (least distress) to 100 (most distress). Lower scores indicate better function / fewer symptoms. Change = (Month \[6, 12, 18, 24, and 36\] Score - Baseline Score).
Outcome measures
| Measure |
UPHOLD
n=88 Participants
UPHOLD Procedure
|
USLS
n=87 Participants
Vaginal hysterectomy and Uterosacral Ligament Suspension (USLS)
|
|---|---|---|
|
Change From Baseline PFDI Score
6 Months
|
-81.7 units on a scale
Interval -93.3 to -70.1
|
-73 units on a scale
Interval -84.8 to -61.1
|
|
Change From Baseline PFDI Score
24 Months
|
-82.1 units on a scale
Interval -93.9 to -70.2
|
-76.6 units on a scale
Interval -88.7 to -64.5
|
|
Change From Baseline PFDI Score
12 Months
|
-81.2 units on a scale
Interval -92.9 to -69.6
|
-75.4 units on a scale
Interval -87.3 to -63.5
|
|
Change From Baseline PFDI Score
18 Months
|
-78.7 units on a scale
Interval -90.5 to -67.0
|
-75.8 units on a scale
Interval -87.8 to -63.9
|
|
Change From Baseline PFDI Score
36 Months
|
-79.8 units on a scale
Interval -91.7 to -67.8
|
-80.1 units on a scale
Interval -92.3 to -67.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6, 12, 18, 24, and 36 MonthsPopulation: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and received the assigned treatment. Participants were included at each time point at which they provided outcome data after baseline.
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 on the CRADI is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Scores are calculated by multiplying the mean value of all questions answered by 25 for the scale. The range of responses is: 0-100 with 0 (least distress) to 100 (most distress). Lower scores indicate better function / fewer symptoms. Change = (Month \[6, 12, 18, 24, and 36\] Score - Baseline Score).
Outcome measures
| Measure |
UPHOLD
n=88 Participants
UPHOLD Procedure
|
USLS
n=87 Participants
Vaginal hysterectomy and Uterosacral Ligament Suspension (USLS)
|
|---|---|---|
|
Change From Baseline CRADI Score
6 Months
|
-11.5 units on a scale
Interval -15.6 to -7.4
|
-11.1 units on a scale
Interval -15.3 to -6.9
|
|
Change From Baseline CRADI Score
12 Months
|
-11.1 units on a scale
Interval -15.2 to -7.0
|
-11.2 units on a scale
Interval -15.4 to -7.0
|
|
Change From Baseline CRADI Score
18 Months
|
-10.6 units on a scale
Interval -14.8 to -6.5
|
-11.9 units on a scale
Interval -16.1 to -7.6
|
|
Change From Baseline CRADI Score
24 Months
|
-12.4 units on a scale
Interval -16.6 to -8.2
|
-11.4 units on a scale
Interval -15.7 to -7.2
|
|
Change From Baseline CRADI Score
36 Months
|
-11.4 units on a scale
Interval -15.6 to -7.2
|
-11.6 units on a scale
Interval -15.9 to -7.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6, 12, 18, 24, and 36 MonthsPopulation: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and received the assigned treatment. Participants were included at each time point at which they provided outcome data after baseline.
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 on the CRADI is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Scores are calculated by multiplying the mean value of all questions answered by 25 for the scale. The range of responses is: 0-100 with 0 (least distress) to 100 (most distress). Lower scores indicate better function / fewer symptoms. Change = (Month \[6, 12, 18, 24, and 36\] Score - Baseline Score).
Outcome measures
| Measure |
UPHOLD
n=88 Participants
UPHOLD Procedure
|
USLS
n=87 Participants
Vaginal hysterectomy and Uterosacral Ligament Suspension (USLS)
|
|---|---|---|
|
Change From Baseline POPDI Score
6 Months
|
-40.7 units on a scale
Interval -45.7 to -35.7
|
-37 units on a scale
Interval -42.1 to -31.9
|
|
Change From Baseline POPDI Score
12 Months
|
-41.1 units on a scale
Interval -46.0 to -36.1
|
-37.4 units on a scale
Interval -42.5 to -32.3
|
|
Change From Baseline POPDI Score
18 Months
|
-40.3 units on a scale
Interval -45.3 to -35.3
|
-37.4 units on a scale
Interval -42.5 to -32.3
|
|
Change From Baseline POPDI Score
24 Months
|
-41.2 units on a scale
Interval -46.3 to -36.2
|
-38 units on a scale
Interval -43.1 to -32.8
|
|
Change From Baseline POPDI Score
36 Months
|
-40.1 units on a scale
Interval -45.2 to -35.0
|
-40.2 units on a scale
Interval -45.5 to -35.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6, 12, 18, 24, and 36 MonthsPopulation: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and received the assigned treatment. Participants were included at each time point at which they provided outcome data after baseline.
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 on the CRADI is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Scores are calculated by multiplying the mean value of all questions answered by 25 for the scale. The range of responses is: 0-100 with 0 (least distress) to 100 (most distress). Lower scores indicate better function / fewer symptoms. Change = (Month \[6, 12, 18, 24, and 36\] Score - Baseline Score).
Outcome measures
| Measure |
UPHOLD
n=88 Participants
UPHOLD Procedure
|
USLS
n=87 Participants
Vaginal hysterectomy and Uterosacral Ligament Suspension (USLS)
|
|---|---|---|
|
Change From Baseline UDI Score
6 Months
|
-29.5 units on a scale
Interval -35.2 to -23.8
|
-24.8 units on a scale
Interval -30.7 to -19.0
|
|
Change From Baseline UDI Score
12 Months
|
-29.1 units on a scale
Interval -34.8 to -23.3
|
-26.8 units on a scale
Interval -32.7 to -20.9
|
|
Change From Baseline UDI Score
18 Months
|
-27.8 units on a scale
Interval -33.6 to -22.0
|
-26.6 units on a scale
Interval -32.5 to -20.7
|
|
Change From Baseline UDI Score
24 Months
|
-28.4 units on a scale
Interval -34.3 to -22.6
|
-27.3 units on a scale
Interval -33.3 to -21.3
|
|
Change From Baseline UDI Score
36 Months
|
-28.3 units on a scale
Interval -34.2 to -22.4
|
-28.2 units on a scale
Interval -34.3 to -22.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6, 12, 18, 24, and 36 MonthsPopulation: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and received the assigned treatment. Participants were included at each time point at which they provided outcome data after baseline.
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 3 scales of 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 the CRAIQ is 0-3 with (0) Not at all, (1) Somewhat, (2) Moderately, and (3), Quite a bit. Scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of responses is: 0-100 with 0 (least negative impact) to 100 (most negative impact). Lower scores indicate better function / fewer symptoms. Change = (Month \[6, 12, 18, 24, and 36\] Score - Baseline Score).
Outcome measures
| Measure |
UPHOLD
n=88 Participants
UPHOLD Procedure
|
USLS
n=87 Participants
Vaginal hysterectomy and Uterosacral Ligament Suspension (USLS)
|
|---|---|---|
|
Change From Baseline PFIQ Score
6 Months
|
-42.9 units on a scale
Interval -53.9 to -31.9
|
-46.7 units on a scale
Interval -57.9 to -35.5
|
|
Change From Baseline PFIQ Score
12 Months
|
-38.3 units on a scale
Interval -49.3 to -27.3
|
-47.4 units on a scale
Interval -58.7 to -36.2
|
|
Change From Baseline PFIQ Score
18 Months
|
-40.1 units on a scale
Interval -51.2 to -29.1
|
-50.1 units on a scale
Interval -61.4 to -38.8
|
|
Change From Baseline PFIQ Score
24 Months
|
-44 units on a scale
Interval -55.1 to -32.8
|
-48.8 units on a scale
Interval -60.2 to -37.4
|
|
Change From Baseline PFIQ Score
36 Months
|
-43.4 units on a scale
Interval -54.6 to -32.2
|
-50.4 units on a scale
Interval -61.9 to -38.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6, 12, 18, 24, and 36 MonthsPopulation: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and received the assigned treatment. Participants were included at each time point at which they provided outcome data after baseline.
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 3 scales of 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 the CRAIQ is 0-3 with (0) Not at all, (1) Somewhat, (2) Moderately, and (3), Quite a bit. Scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of responses is: 0-100 with 0 (least negative impact) to 100 (most negative impact). Lower scores indicate better function / fewer symptoms. Change = (Month \[6, 12, 18, 24, and 36\] Score - Baseline Score).
Outcome measures
| Measure |
UPHOLD
n=88 Participants
UPHOLD Procedure
|
USLS
n=87 Participants
Vaginal hysterectomy and Uterosacral Ligament Suspension (USLS)
|
|---|---|---|
|
Change From Baseline CRAIQ Score
6 Months
|
-6.7 units on a scale
Interval -10.8 to -2.6
|
-10.1 units on a scale
Interval -14.3 to -5.9
|
|
Change From Baseline CRAIQ Score
12 Months
|
-4.7 units on a scale
Interval -8.8 to -0.6
|
-9.5 units on a scale
Interval -13.7 to -5.3
|
|
Change From Baseline CRAIQ Score
18 Months
|
-4.6 units on a scale
Interval -8.7 to -0.5
|
-9.6 units on a scale
Interval -13.8 to -5.4
|
|
Change From Baseline CRAIQ Score
24 Months
|
-7.3 units on a scale
Interval -11.4 to -3.1
|
-9.7 units on a scale
Interval -13.9 to -5.4
|
|
Change From Baseline CRAIQ Score
36 Months
|
-6.1 units on a scale
Interval -10.3 to -1.9
|
-9.8 units on a scale
Interval -14.1 to -5.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6, 12, 18, 24, and 36 MonthsPopulation: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and received the assigned treatment. Participants were included at each time point at which they provided outcome data after baseline.
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 3 scales of 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 the CRAIQ is 0-3 with (0) Not at all, (1) Somewhat, (2) Moderately, and (3), Quite a bit. Scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of responses is: 0-100 with 0 (least negative impact) to 100 (most negative impact). Lower scores indicate better function / fewer symptoms. Change = (Month \[6, 12, 18, 24, and 36\] Score - Baseline Score).
Outcome measures
| Measure |
UPHOLD
n=88 Participants
UPHOLD Procedure
|
USLS
n=87 Participants
Vaginal hysterectomy and Uterosacral Ligament Suspension (USLS)
|
|---|---|---|
|
Change From Baseline POPIQ Score
6 Months
|
-15.7 units on a scale
Interval -20.6 to -10.9
|
-18.9 units on a scale
Interval -23.9 to -13.9
|
|
Change From Baseline POPIQ Score
12 Months
|
-14.6 units on a scale
Interval -19.4 to -9.7
|
-19.5 units on a scale
Interval -24.5 to -14.5
|
|
Change From Baseline POPIQ Score
18 Months
|
-15.9 units on a scale
Interval -20.8 to -11.1
|
-20.1 units on a scale
Interval -25.1 to -15.1
|
|
Change From Baseline POPIQ Score
24 Months
|
-15.9 units on a scale
Interval -20.8 to -11.0
|
-19.1 units on a scale
Interval -24.1 to -14.0
|
|
Change From Baseline POPIQ Score
36 Months
|
-16 units on a scale
Interval -21.0 to -11.1
|
-19.9 units on a scale
Interval -25.0 to -14.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6, 12, 18, 24, and 36 MonthsPopulation: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and received the assigned treatment. Participants were included at each time point at which they provided outcome data after baseline.
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 3 scales of 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 the CRAIQ is 0-3 with (0) Not at all, (1) Somewhat, (2) Moderately, and (3), Quite a bit. Scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of responses is: 0-100 with 0 (least negative impact) to 100 (most negative impact). Lower scores indicate better function / fewer symptoms. Change = (Month \[6, 12, 18, 24, and 36\] Score - Baseline Score).
Outcome measures
| Measure |
UPHOLD
n=88 Participants
UPHOLD Procedure
|
USLS
n=87 Participants
Vaginal hysterectomy and Uterosacral Ligament Suspension (USLS)
|
|---|---|---|
|
Change From Baseline UIQ Score
6 Months
|
-20.5 units on a scale
Interval -25.5 to -15.5
|
-17.7 units on a scale
Interval -22.8 to -12.6
|
|
Change From Baseline UIQ Score
12 Months
|
-19 units on a scale
Interval -24.0 to -14.1
|
-18.4 units on a scale
Interval -23.5 to -13.4
|
|
Change From Baseline UIQ Score
18 Months
|
-19.5 units on a scale
Interval -24.5 to -14.6
|
-20.4 units on a scale
Interval -25.5 to -15.3
|
|
Change From Baseline UIQ Score
24 Months
|
-20.8 units on a scale
Interval -25.8 to -15.7
|
-20.1 units on a scale
Interval -25.3 to -15.0
|
|
Change From Baseline UIQ Score
36 Months
|
-21.3 units on a scale
Interval -26.3 to -16.2
|
-20.6 units on a scale
Interval -25.8 to -15.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6, 12, 18, 24, and 36 MonthsPopulation: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and received the assigned treatment. Participants were included at each time point at which they provided outcome data after baseline.
Incontinence Severity Index measuring the severity of urinary incontinence is composed of 2 questions: frequency of leakage (0=Never,...,4=Every day/night) and amount of urine leakage (1=Drops, 2=small splashes, 3= More). The index score is calculated categorizing the product of the two responses. The range of responses is: 0 (no incontinence) to 12 (severe incontinence). Lower index scores indicate better function / fewer symptoms. Change = (Month \[6, 12, 18, 24, and 36\] Score - Baseline Score).
Outcome measures
| Measure |
UPHOLD
n=88 Participants
UPHOLD Procedure
|
USLS
n=87 Participants
Vaginal hysterectomy and Uterosacral Ligament Suspension (USLS)
|
|---|---|---|
|
Change From Baseline Incontinence Severity Index
6 Months
|
-2.4 units on a scale
Interval -3.2 to -1.6
|
-1.3 units on a scale
Interval -2.1 to -0.6
|
|
Change From Baseline Incontinence Severity Index
12 Months
|
-2.1 units on a scale
Interval -2.9 to -1.3
|
-1.4 units on a scale
Interval -2.2 to -0.6
|
|
Change From Baseline Incontinence Severity Index
18 Months
|
-2.1 units on a scale
Interval -2.9 to -1.3
|
-1.3 units on a scale
Interval -2.1 to -0.5
|
|
Change From Baseline Incontinence Severity Index
24 Months
|
-1.9 units on a scale
Interval -2.7 to -1.2
|
-1.4 units on a scale
Interval -2.2 to -0.6
|
|
Change From Baseline Incontinence Severity Index
36 Months
|
-1.9 units on a scale
Interval -2.7 to -1.1
|
-1.6 units on a scale
Interval -2.5 to -0.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6, 12, 18, 24, and 36 MonthsPopulation: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and received the assigned treatment. Participants were included at each time point at which they provided outcome data after baseline.
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 |
UPHOLD
n=88 Participants
UPHOLD Procedure
|
USLS
n=87 Participants
Vaginal hysterectomy and Uterosacral Ligament Suspension (USLS)
|
|---|---|---|
|
Change From Baseline Functional Activity Scale
6 Months
|
6.3 units on a scale
Interval 3.5 to 9.0
|
7.7 units on a scale
Interval 4.9 to 10.5
|
|
Change From Baseline Functional Activity Scale
12 Months
|
6.3 units on a scale
Interval 3.6 to 9.1
|
6 units on a scale
Interval 3.2 to 8.8
|
|
Change From Baseline Functional Activity Scale
18 Months
|
5.8 units on a scale
Interval 3.0 to 8.5
|
6.6 units on a scale
Interval 3.8 to 9.5
|
|
Change From Baseline Functional Activity Scale
24 Months
|
4.9 units on a scale
Interval 2.1 to 7.7
|
6.2 units on a scale
Interval 3.3 to 9.0
|
|
Change From Baseline Functional Activity Scale
36 Months
|
5.6 units on a scale
Interval 2.8 to 8.5
|
4.8 units on a scale
Interval 1.9 to 7.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6, 12, 18, 24, 30, and 36 MonthsPopulation: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and received the assigned treatment. Participants were included at each time point at which they provided outcome data after baseline.
The Body Part Pain Scale measuring the 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 |
UPHOLD
n=88 Participants
UPHOLD Procedure
|
USLS
n=87 Participants
Vaginal hysterectomy and Uterosacral Ligament Suspension (USLS)
|
|---|---|---|
|
Change From Baseline Body Part Pain Scale
6 Months
|
-0.4 units on a scale
Interval -0.6 to -0.2
|
-0.3 units on a scale
Interval -0.5 to -0.1
|
|
Change From Baseline Body Part Pain Scale
12 Months
|
-0.5 units on a scale
Interval -0.7 to -0.3
|
-0.3 units on a scale
Interval -0.5 to -0.1
|
|
Change From Baseline Body Part Pain Scale
18 Months
|
-0.5 units on a scale
Interval -0.7 to -0.3
|
-0.3 units on a scale
Interval -0.5 to -0.1
|
|
Change From Baseline Body Part Pain Scale
24 Months
|
-0.6 units on a scale
Interval -0.8 to -0.3
|
-0.3 units on a scale
Interval -0.6 to -0.1
|
|
Change From Baseline Body Part Pain Scale
30 Months
|
-0.5 units on a scale
Interval -0.7 to -0.3
|
-0.3 units on a scale
Interval -0.5 to -0.1
|
|
Change From Baseline Body Part Pain Scale
36 Months
|
-0.5 units on a scale
Interval -0.7 to -0.3
|
-0.3 units on a scale
Interval -0.5 to -0.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6, 12, 18, 24, and 36 MonthsPopulation: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and received the assigned treatment. Participants were included at each time point at which they provided outcome data after baseline.
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. Change = (Month \[6, 12, 18, 24, and 36\] Score - Baseline Score).
Outcome measures
| Measure |
UPHOLD
n=88 Participants
UPHOLD Procedure
|
USLS
n=87 Participants
Vaginal hysterectomy and Uterosacral Ligament Suspension (USLS)
|
|---|---|---|
|
Change From Baseline Surgical Pain Scale Rest Score
36 Months
|
-0.5 units on a scale
Interval -1.0 to -0.1
|
-0.6 units on a scale
Interval -1.1 to -0.2
|
|
Change From Baseline Surgical Pain Scale Rest Score
6 Months
|
-0.7 units on a scale
Interval -1.1 to -0.3
|
-0.8 units on a scale
Interval -1.2 to -0.3
|
|
Change From Baseline Surgical Pain Scale Rest Score
12 Months
|
-0.6 units on a scale
Interval -1.0 to -0.2
|
-0.7 units on a scale
Interval -1.1 to -0.2
|
|
Change From Baseline Surgical Pain Scale Rest Score
18 Months
|
-0.6 units on a scale
Interval -1.0 to -0.2
|
-0.8 units on a scale
Interval -1.2 to -0.4
|
|
Change From Baseline Surgical Pain Scale Rest Score
24 Months
|
-0.7 units on a scale
Interval -1.2 to -0.3
|
-0.5 units on a scale
Interval -0.9 to -0.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6, 12, 18, 24, and 36 MonthsPopulation: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and received the assigned treatment. Participants were included at each time point at which they provided outcome data after baseline.
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. Change = (Month \[6, 12, 18, 24, and 36\] Score - Baseline Score).
Outcome measures
| Measure |
UPHOLD
n=88 Participants
UPHOLD Procedure
|
USLS
n=87 Participants
Vaginal hysterectomy and Uterosacral Ligament Suspension (USLS)
|
|---|---|---|
|
Change From Baseline Surgical Pain Scale Normal Score
6 Months
|
-0.9 units on a scale
Interval -1.3 to -0.4
|
-0.8 units on a scale
Interval -1.3 to -0.4
|
|
Change From Baseline Surgical Pain Scale Normal Score
12 Months
|
-0.9 units on a scale
Interval -1.3 to -0.4
|
-0.8 units on a scale
Interval -1.3 to -0.4
|
|
Change From Baseline Surgical Pain Scale Normal Score
18 Months
|
-1 units on a scale
Interval -1.4 to -0.5
|
-0.8 units on a scale
Interval -1.3 to -0.4
|
|
Change From Baseline Surgical Pain Scale Normal Score
24 Months
|
-1 units on a scale
Interval -1.4 to -0.5
|
-0.6 units on a scale
Interval -1.0 to -0.1
|
|
Change From Baseline Surgical Pain Scale Normal Score
36 Months
|
-0.7 units on a scale
Interval -1.2 to -0.2
|
-0.7 units on a scale
Interval -1.2 to -0.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6, 12, 18, 24, and 36 MonthsPopulation: AAn intent-to-treat (ITT) analysis which included all eligible participants who were randomized and received the assigned treatment. Participants were included at each time point at which they provided outcome data after baseline. This outcome measure is only calculated for individuals who reported exercising.
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. Change = (Month \[6, 12, 18, 24, and 36\] Score - Baseline Score).
Outcome measures
| Measure |
UPHOLD
n=53 Participants
UPHOLD Procedure
|
USLS
n=52 Participants
Vaginal hysterectomy and Uterosacral Ligament Suspension (USLS)
|
|---|---|---|
|
Change From Baseline Surgical Pain Scale Exercise Score
6 Months
|
-1 units on a scale
Interval -1.7 to -0.3
|
-1.4 units on a scale
Interval -2.1 to -0.6
|
|
Change From Baseline Surgical Pain Scale Exercise Score
12 Months
|
-0.9 units on a scale
Interval -1.6 to -0.2
|
-1.1 units on a scale
Interval -1.8 to -0.4
|
|
Change From Baseline Surgical Pain Scale Exercise Score
18 Months
|
-0.9 units on a scale
Interval -1.6 to -0.2
|
-1.2 units on a scale
Interval -1.9 to -0.5
|
|
Change From Baseline Surgical Pain Scale Exercise Score
24 Months
|
-1 units on a scale
Interval -1.7 to -0.3
|
-0.9 units on a scale
Interval -1.7 to -0.1
|
|
Change From Baseline Surgical Pain Scale Exercise Score
36 Months
|
-1.2 units on a scale
Interval -2.0 to -0.5
|
-0.9 units on a scale
Interval -1.7 to -0.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6, 12, 18, 24, and 36 MonthsPopulation: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and received the assigned treatment. Participants were included at each time point at which they provided outcome data after baseline.
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. Change = (Month \[6, 12, 18, 24, and 36\] Score - Baseline Score).
Outcome measures
| Measure |
UPHOLD
n=88 Participants
UPHOLD Procedure
|
USLS
n=87 Participants
Vaginal hysterectomy and Uterosacral Ligament Suspension (USLS)
|
|---|---|---|
|
Change From Baseline Surgical Pain Scale Worst Score
36 Months
|
-0.8 units on a scale
Interval -1.4 to -0.3
|
-0.5 units on a scale
Interval -1.1 to 0.0
|
|
Change From Baseline Surgical Pain Scale Worst Score
6 Months
|
-0.8 units on a scale
Interval -1.3 to -0.3
|
-0.9 units on a scale
Interval -1.4 to -0.4
|
|
Change From Baseline Surgical Pain Scale Worst Score
12 Months
|
-1 units on a scale
Interval -1.5 to -0.5
|
-0.7 units on a scale
Interval -1.3 to -0.2
|
|
Change From Baseline Surgical Pain Scale Worst Score
18 Months
|
-0.9 units on a scale
Interval -1.5 to -0.4
|
-0.9 units on a scale
Interval -1.5 to -0.4
|
|
Change From Baseline Surgical Pain Scale Worst Score
24 Months
|
-1 units on a scale
Interval -1.6 to -0.5
|
-0.6 units on a scale
Interval -1.2 to 0.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6, 12, 18, 24, and 36 MonthsPopulation: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and received the assigned treatment. Participants were included at each time point at which they provided outcome data after baseline.
The Body Image Scale measuring how the subjects feel about their appearance and about any changes that may have resulted from their condition consists of 8 questions. The questions are scored from 0=Not at all,..., 3=Very much. The score is calculated by summing the responses and ranges from 0 to 24. Higher scores correspond to worse body image. Change = Month \[6, 12, 18, 24, and 36\] Score - Baseline Score.
Outcome measures
| Measure |
UPHOLD
n=88 Participants
UPHOLD Procedure
|
USLS
n=87 Participants
Vaginal hysterectomy and Uterosacral Ligament Suspension (USLS)
|
|---|---|---|
|
Change From Baseline Body Image Scale
12 Months
|
-4.9 units on a scale
Interval -6.1 to -3.7
|
-3.9 units on a scale
Interval -5.1 to -2.7
|
|
Change From Baseline Body Image Scale
6 Months
|
-5 units on a scale
Interval -6.1 to -3.8
|
-3.7 units on a scale
Interval -4.9 to -2.6
|
|
Change From Baseline Body Image Scale
18 Months
|
-4.8 units on a scale
Interval -6.0 to -3.6
|
-3.9 units on a scale
Interval -5.1 to -2.7
|
|
Change From Baseline Body Image Scale
24 Months
|
-4.8 units on a scale
Interval -6.0 to -3.6
|
-3.8 units on a scale
Interval -5.0 to -2.6
|
|
Change From Baseline Body Image Scale
36 Months
|
-4.9 units on a scale
Interval -6.1 to -3.7
|
-3.8 units on a scale
Interval -5.0 to -2.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6, 12, 18, 24, and 36 MonthsPopulation: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and received the assigned treatment. Participants were included at each time point at which they provided outcome data after baseline. This outcome measure is only calculated for individuals who report being sexually active.
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 |
UPHOLD
n=30 Participants
UPHOLD Procedure
|
USLS
n=40 Participants
Vaginal hysterectomy and Uterosacral Ligament Suspension (USLS)
|
|---|---|---|
|
Change From Baseline PISQ-IR Sexually Active Average Score
6 Months
|
0.2 units on a scale
Interval 0.1 to 0.4
|
0.3 units on a scale
Interval 0.1 to 0.5
|
|
Change From Baseline PISQ-IR Sexually Active Average Score
12 Months
|
0.2 units on a scale
Interval 0.0 to 0.4
|
0.3 units on a scale
Interval 0.1 to 0.5
|
|
Change From Baseline PISQ-IR Sexually Active Average Score
18 Months
|
0.3 units on a scale
Interval 0.1 to 0.4
|
0.2 units on a scale
Interval 0.1 to 0.4
|
|
Change From Baseline PISQ-IR Sexually Active Average Score
24 Months
|
0.3 units on a scale
Interval 0.1 to 0.5
|
0.3 units on a scale
Interval 0.2 to 0.5
|
|
Change From Baseline PISQ-IR Sexually Active Average Score
36 Months
|
0.3 units on a scale
Interval 0.1 to 0.5
|
0.3 units on a scale
Interval 0.1 to 0.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12, 24, and 36 MonthsPopulation: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and received the assigned treatment. Participants were included at each time point at which they provided outcome data after baseline.
The Pelvic Organ Prolapse Quantification (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 |
UPHOLD
n=88 Participants
UPHOLD Procedure
|
USLS
n=87 Participants
Vaginal hysterectomy and Uterosacral Ligament Suspension (USLS)
|
|---|---|---|
|
POP-Q Ba Measurement
12 Months
|
-1.3 cm
Interval -1.6 to -1.0
|
-0.8 cm
Interval -1.1 to -0.5
|
|
POP-Q Ba Measurement
24 Months
|
-1.5 cm
Interval -1.8 to -1.2
|
-1.1 cm
Interval -1.4 to -0.7
|
|
POP-Q Ba Measurement
36 Months
|
-1.2 cm
Interval -1.5 to -0.8
|
-0.7 cm
Interval -1.0 to -0.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12, 24, and 36 MonthsPopulation: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and received the assigned treatment. Participants were included at each time point at which they provided outcome data after baseline.
The Pelvic Organ Prolapse Quantification (POPQ) 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 |
UPHOLD
n=88 Participants
UPHOLD Procedure
|
USLS
n=87 Participants
Vaginal hysterectomy and Uterosacral Ligament Suspension (USLS)
|
|---|---|---|
|
POP-Q Bp Measurement
12 Months
|
-1.9 cm
Interval -2.2 to -1.6
|
-2 cm
Interval -2.2 to -1.7
|
|
POP-Q Bp Measurement
24 Months
|
-1.8 cm
Interval -2.1 to -1.5
|
-2 cm
Interval -2.2 to -1.8
|
|
POP-Q Bp Measurement
36 Months
|
-1.7 cm
Interval -2.1 to -1.4
|
-1.8 cm
Interval -2.1 to -1.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12, 24, and 36 MonthsPopulation: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and received the assigned treatment. Participants were included at each time point at which they provided outcome data after baseline.
The Pelvic Organ Prolapse Quantification (POPQ) 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 |
UPHOLD
n=88 Participants
UPHOLD Procedure
|
USLS
n=87 Participants
Vaginal hysterectomy and Uterosacral Ligament Suspension (USLS)
|
|---|---|---|
|
POP-Q C Measurement
12 Months
|
-5.6 cm
Interval -6.2 to -5.0
|
-6.1 cm
Interval -6.6 to -5.6
|
|
POP-Q C Measurement
24 Months
|
-6 cm
Interval -6.4 to -5.5
|
-6.1 cm
Interval -6.4 to -5.7
|
|
POP-Q C Measurement
36 Months
|
-5.7 cm
Interval -6.2 to -5.1
|
-5.8 cm
Interval -6.2 to -5.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12, 24, and 36 MonthsPopulation: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and received the assigned treatment. Participants were included at each time point at which they provided outcome data after baseline.
The Pelvic Organ Prolapse Quantification (POPQ) Total Vaginal Length (TVL) is the length of the vagina from posterior fornix tothe hymen when Point C or D is reduced to its full normal position.
Outcome measures
| Measure |
UPHOLD
n=88 Participants
UPHOLD Procedure
|
USLS
n=87 Participants
Vaginal hysterectomy and Uterosacral Ligament Suspension (USLS)
|
|---|---|---|
|
POP-Q TVL Measurement
12 Months
|
8.5 cm
Interval 8.3 to 8.7
|
8 cm
Interval 7.7 to 8.2
|
|
POP-Q TVL Measurement
24 Months
|
8.6 cm
Interval 8.4 to 8.9
|
7.8 cm
Interval 7.5 to 8.0
|
|
POP-Q TVL Measurement
36 Months
|
8.5 cm
Interval 8.2 to 8.7
|
7.7 cm
Interval 7.4 to 8.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6,12, 18, 24, and 36 MonthsPopulation: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and received the assigned treatment. Participants were included at each time point at which they provided outcome data after baseline.
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 |
UPHOLD
n=88 Participants
UPHOLD Procedure
|
USLS
n=87 Participants
Vaginal hysterectomy and Uterosacral Ligament Suspension (USLS)
|
|---|---|---|
|
PGI-I
6 Months · No improvement
|
79 Participants
|
81 Participants
|
|
PGI-I
6 Months · Improved
|
8 Participants
|
4 Participants
|
|
PGI-I
12 Months · No improvement
|
75 Participants
|
76 Participants
|
|
PGI-I
12 Months · Improved
|
11 Participants
|
8 Participants
|
|
PGI-I
18 Months · No improvement
|
70 Participants
|
76 Participants
|
|
PGI-I
18 Months · Improved
|
12 Participants
|
7 Participants
|
|
PGI-I
24 Months · No improvement
|
69 Participants
|
71 Participants
|
|
PGI-I
24 Months · Improved
|
10 Participants
|
8 Participants
|
|
PGI-I
36 Months · No improvement
|
70 Participants
|
67 Participants
|
|
PGI-I
36 Months · Improved
|
8 Participants
|
8 Participants
|
Adverse Events
Hysterectomy
Hysteropexy
Serious adverse events
| Measure |
Hysterectomy
n=90 participants at risk
Vaginal hysterectomy and Uterosacral Ligament Suspension (USLS)
|
Hysteropexy
n=93 participants at risk
UPHOLD Procedure
|
|---|---|---|
|
Gastrointestinal disorders
Colitis
|
2.2%
2/90 • Number of events 2 • 36 Months
|
0.00%
0/93 • 36 Months
|
|
Gastrointestinal disorders
Colitis ischaemic
|
1.1%
1/90 • Number of events 1 • 36 Months
|
0.00%
0/93 • 36 Months
|
|
Gastrointestinal disorders
Constipation
|
1.1%
1/90 • Number of events 1 • 36 Months
|
0.00%
0/93 • 36 Months
|
|
Gastrointestinal disorders
Diverticular perforation
|
1.1%
1/90 • Number of events 1 • 36 Months
|
0.00%
0/93 • 36 Months
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/90 • 36 Months
|
1.1%
1/93 • Number of events 1 • 36 Months
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/90 • 36 Months
|
1.1%
1/93 • Number of events 1 • 36 Months
|
|
Infections and infestations
Urosepsis
|
0.00%
0/90 • 36 Months
|
1.1%
1/93 • Number of events 1 • 36 Months
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
1.1%
1/90 • Number of events 1 • 36 Months
|
0.00%
0/93 • 36 Months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.1%
1/90 • Number of events 1 • 36 Months
|
0.00%
0/93 • 36 Months
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/90 • 36 Months
|
2.2%
2/93 • Number of events 2 • 36 Months
|
|
Renal and urinary disorders
Bladder spasm
|
1.1%
1/90 • Number of events 1 • 36 Months
|
0.00%
0/93 • 36 Months
|
|
Renal and urinary disorders
Stress urinary incontinence
|
2.2%
2/90 • Number of events 2 • 36 Months
|
0.00%
0/93 • 36 Months
|
|
Reproductive system and breast disorders
Dyspareunia
|
0.00%
0/90 • 36 Months
|
1.1%
1/93 • Number of events 2 • 36 Months
|
|
Reproductive system and breast disorders
Rectocele
|
1.1%
1/90 • Number of events 1 • 36 Months
|
0.00%
0/93 • 36 Months
|
|
Reproductive system and breast disorders
Vulvovaginal pain
|
1.1%
1/90 • Number of events 1 • 36 Months
|
0.00%
0/93 • 36 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/90 • 36 Months
|
2.2%
2/93 • Number of events 2 • 36 Months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/90 • 36 Months
|
1.1%
1/93 • Number of events 1 • 36 Months
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/90 • 36 Months
|
2.2%
2/93 • Number of events 3 • 36 Months
|
|
Vascular disorders
Haematoma
|
1.1%
1/90 • Number of events 1 • 36 Months
|
0.00%
0/93 • 36 Months
|
Other adverse events
| Measure |
Hysterectomy
n=90 participants at risk
Vaginal hysterectomy and Uterosacral Ligament Suspension (USLS)
|
Hysteropexy
n=93 participants at risk
UPHOLD Procedure
|
|---|---|---|
|
Cardiac disorders
Arrhythmia
|
1.1%
1/90 • Number of events 1 • 36 Months
|
0.00%
0/93 • 36 Months
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/90 • 36 Months
|
1.1%
1/93 • Number of events 1 • 36 Months
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/90 • 36 Months
|
1.1%
1/93 • Number of events 1 • 36 Months
|
|
Gastrointestinal disorders
Abdominal pain
|
2.2%
2/90 • Number of events 2 • 36 Months
|
3.2%
3/93 • Number of events 3 • 36 Months
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/90 • 36 Months
|
1.1%
1/93 • Number of events 2 • 36 Months
|
|
Gastrointestinal disorders
Constipation
|
14.4%
13/90 • Number of events 14 • 36 Months
|
5.4%
5/93 • Number of events 6 • 36 Months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/90 • 36 Months
|
2.2%
2/93 • Number of events 2 • 36 Months
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/90 • 36 Months
|
1.1%
1/93 • Number of events 1 • 36 Months
|
|
Gastrointestinal disorders
Faecal incontinence
|
4.4%
4/90 • Number of events 5 • 36 Months
|
10.8%
10/93 • Number of events 11 • 36 Months
|
|
Gastrointestinal disorders
Gastric ulcer
|
1.1%
1/90 • Number of events 1 • 36 Months
|
0.00%
0/93 • 36 Months
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.1%
1/90 • Number of events 1 • 36 Months
|
1.1%
1/93 • Number of events 1 • 36 Months
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.1%
1/90 • Number of events 1 • 36 Months
|
1.1%
1/93 • Number of events 1 • 36 Months
|
|
Gastrointestinal disorders
Levator syndrome
|
0.00%
0/90 • 36 Months
|
2.2%
2/93 • Number of events 2 • 36 Months
|
|
Gastrointestinal disorders
Nausea
|
1.1%
1/90 • Number of events 1 • 36 Months
|
0.00%
0/93 • 36 Months
|
|
Gastrointestinal disorders
Peritoneal perforation
|
1.1%
1/90 • Number of events 1 • 36 Months
|
0.00%
0/93 • 36 Months
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
1.1%
1/90 • Number of events 1 • 36 Months
|
0.00%
0/93 • 36 Months
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.1%
1/90 • Number of events 1 • 36 Months
|
0.00%
0/93 • 36 Months
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
1/90 • Number of events 1 • 36 Months
|
0.00%
0/93 • 36 Months
|
|
General disorders
Device malfunction
|
0.00%
0/90 • 36 Months
|
2.2%
2/93 • Number of events 2 • 36 Months
|
|
General disorders
Feeling hot
|
1.1%
1/90 • Number of events 1 • 36 Months
|
0.00%
0/93 • 36 Months
|
|
General disorders
Local swelling
|
0.00%
0/90 • 36 Months
|
1.1%
1/93 • Number of events 1 • 36 Months
|
|
Infections and infestations
Bacterial vaginosis
|
1.1%
1/90 • Number of events 1 • 36 Months
|
4.3%
4/93 • Number of events 4 • 36 Months
|
|
Infections and infestations
Cellulitis
|
1.1%
1/90 • Number of events 1 • 36 Months
|
0.00%
0/93 • 36 Months
|
|
Infections and infestations
Clostridium difficile colitis
|
1.1%
1/90 • Number of events 1 • 36 Months
|
0.00%
0/93 • 36 Months
|
|
Infections and infestations
Fungal infection
|
0.00%
0/90 • 36 Months
|
1.1%
1/93 • Number of events 1 • 36 Months
|
|
Infections and infestations
Groin abscess
|
0.00%
0/90 • 36 Months
|
1.1%
1/93 • Number of events 1 • 36 Months
|
|
Infections and infestations
Urinary tract infection
|
43.3%
39/90 • Number of events 69 • 36 Months
|
36.6%
34/93 • Number of events 59 • 36 Months
|
|
Infections and infestations
Vaginal infection
|
5.6%
5/90 • Number of events 5 • 36 Months
|
3.2%
3/93 • Number of events 3 • 36 Months
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/90 • 36 Months
|
1.1%
1/93 • Number of events 1 • 36 Months
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
2.2%
2/90 • Number of events 2 • 36 Months
|
1.1%
1/93 • Number of events 1 • 36 Months
|
|
Infections and infestations
Wound infection
|
1.1%
1/90 • Number of events 1 • 36 Months
|
1.1%
1/93 • Number of events 1 • 36 Months
|
|
Injury, poisoning and procedural complications
Bladder injury
|
1.1%
1/90 • Number of events 1 • 36 Months
|
2.2%
2/93 • Number of events 2 • 36 Months
|
|
Injury, poisoning and procedural complications
Femoral nerve injury
|
1.1%
1/90 • Number of events 1 • 36 Months
|
0.00%
0/93 • 36 Months
|
|
Injury, poisoning and procedural complications
Hysteropexy mesh exposure
|
0.00%
0/90 • 36 Months
|
7.5%
7/93 • Number of events 12 • 36 Months
|
|
Injury, poisoning and procedural complications
Midurethral sling mesh exposure
|
2.2%
2/90 • Number of events 3 • 36 Months
|
0.00%
0/93 • 36 Months
|
|
Injury, poisoning and procedural complications
Postoperative thrombosis
|
1.1%
1/90 • Number of events 1 • 36 Months
|
0.00%
0/93 • 36 Months
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.00%
0/90 • 36 Months
|
2.2%
2/93 • Number of events 2 • 36 Months
|
|
Injury, poisoning and procedural complications
Retained fragment of surgical packing
|
1.1%
1/90 • Number of events 1 • 36 Months
|
0.00%
0/93 • 36 Months
|
|
Injury, poisoning and procedural complications
Suture exposure after 12 wks.
|
18.9%
17/90 • Number of events 17 • 36 Months
|
3.2%
3/93 • Number of events 3 • 36 Months
|
|
Injury, poisoning and procedural complications
Ureteric kink
|
7.8%
7/90 • Number of events 7 • 36 Months
|
0.00%
0/93 • 36 Months
|
|
Injury, poisoning and procedural complications
Vaginal laceration
|
1.1%
1/90 • Number of events 1 • 36 Months
|
0.00%
0/93 • 36 Months
|
|
Investigations
Blood culture positive
|
1.1%
1/90 • Number of events 1 • 36 Months
|
0.00%
0/93 • 36 Months
|
|
Investigations
Urine analysis abnormal
|
0.00%
0/90 • 36 Months
|
1.1%
1/93 • Number of events 1 • 36 Months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/90 • 36 Months
|
2.2%
2/93 • Number of events 2 • 36 Months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.1%
1/90 • Number of events 1 • 36 Months
|
3.2%
3/93 • Number of events 3 • 36 Months
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/90 • 36 Months
|
1.1%
1/93 • Number of events 1 • 36 Months
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/90 • 36 Months
|
2.2%
2/93 • Number of events 3 • 36 Months
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
1.1%
1/90 • Number of events 1 • 36 Months
|
0.00%
0/93 • 36 Months
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
1.1%
1/90 • Number of events 1 • 36 Months
|
0.00%
0/93 • 36 Months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/90 • 36 Months
|
1.1%
1/93 • Number of events 1 • 36 Months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/90 • 36 Months
|
1.1%
1/93 • Number of events 1 • 36 Months
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/90 • 36 Months
|
2.2%
2/93 • Number of events 2 • 36 Months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.2%
2/90 • Number of events 2 • 36 Months
|
0.00%
0/93 • 36 Months
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
1.1%
1/90 • Number of events 1 • 36 Months
|
0.00%
0/93 • 36 Months
|
|
Nervous system disorders
Sciatica
|
1.1%
1/90 • Number of events 2 • 36 Months
|
2.2%
2/93 • Number of events 2 • 36 Months
|
|
Renal and urinary disorders
Bladder spasm
|
1.1%
1/90 • Number of events 1 • 36 Months
|
0.00%
0/93 • 36 Months
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/90 • 36 Months
|
2.2%
2/93 • Number of events 3 • 36 Months
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/90 • 36 Months
|
1.1%
1/93 • Number of events 1 • 36 Months
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/90 • 36 Months
|
1.1%
1/93 • Number of events 1 • 36 Months
|
|
Renal and urinary disorders
Nocturia
|
1.1%
1/90 • Number of events 1 • 36 Months
|
0.00%
0/93 • 36 Months
|
|
Renal and urinary disorders
Stress urinary incontinence
|
12.2%
11/90 • Number of events 11 • 36 Months
|
20.4%
19/93 • Number of events 22 • 36 Months
|
|
Renal and urinary disorders
Urethral caruncle
|
0.00%
0/90 • 36 Months
|
1.1%
1/93 • Number of events 1 • 36 Months
|
|
Renal and urinary disorders
Urethral cyst
|
0.00%
0/90 • 36 Months
|
1.1%
1/93 • Number of events 1 • 36 Months
|
|
Renal and urinary disorders
Urethral pain
|
0.00%
0/90 • 36 Months
|
1.1%
1/93 • Number of events 1 • 36 Months
|
|
Renal and urinary disorders
Urge incontinence
|
14.4%
13/90 • Number of events 13 • 36 Months
|
20.4%
19/93 • Number of events 21 • 36 Months
|
|
Renal and urinary disorders
Urinary incontinence
|
2.2%
2/90 • Number of events 2 • 36 Months
|
1.1%
1/93 • Number of events 1 • 36 Months
|
|
Renal and urinary disorders
Urinary retention
|
7.8%
7/90 • Number of events 8 • 36 Months
|
6.5%
6/93 • Number of events 10 • 36 Months
|
|
Reproductive system and breast disorders
Atrophic vulvovaginitis
|
1.1%
1/90 • Number of events 1 • 36 Months
|
7.5%
7/93 • Number of events 8 • 36 Months
|
|
Reproductive system and breast disorders
Bartholin's cyst
|
1.1%
1/90 • Number of events 1 • 36 Months
|
1.1%
1/93 • Number of events 1 • 36 Months
|
|
Reproductive system and breast disorders
Cervical polyp
|
0.00%
0/90 • 36 Months
|
1.1%
1/93 • Number of events 1 • 36 Months
|
|
Reproductive system and breast disorders
Dyspareunia
|
2.2%
2/90 • Number of events 2 • 36 Months
|
7.5%
7/93 • Number of events 7 • 36 Months
|
|
Reproductive system and breast disorders
Fallopian tube prolapse
|
1.1%
1/90 • Number of events 1 • 36 Months
|
0.00%
0/93 • 36 Months
|
|
Reproductive system and breast disorders
Pelvic pain
|
7.8%
7/90 • Number of events 8 • 36 Months
|
3.2%
3/93 • Number of events 3 • 36 Months
|
|
Reproductive system and breast disorders
Perineal pain
|
1.1%
1/90 • Number of events 1 • 36 Months
|
1.1%
1/93 • Number of events 1 • 36 Months
|
|
Reproductive system and breast disorders
Postmenopausal bleeding secondary to atrophy
|
1.1%
1/90 • Number of events 1 • 36 Months
|
4.3%
4/93 • Number of events 5 • 36 Months
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.00%
0/90 • 36 Months
|
1.1%
1/93 • Number of events 1 • 36 Months
|
|
Reproductive system and breast disorders
Rectocele
|
1.1%
1/90 • Number of events 1 • 36 Months
|
0.00%
0/93 • 36 Months
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.00%
0/90 • 36 Months
|
1.1%
1/93 • Number of events 1 • 36 Months
|
|
Reproductive system and breast disorders
Vaginal bleeding
|
1.1%
1/90 • Number of events 1 • 36 Months
|
0.00%
0/93 • 36 Months
|
|
Reproductive system and breast disorders
Vaginal erosion
|
1.1%
1/90 • Number of events 1 • 36 Months
|
0.00%
0/93 • 36 Months
|
|
Reproductive system and breast disorders
Vaginal haematoma
|
0.00%
0/90 • 36 Months
|
1.1%
1/93 • Number of events 1 • 36 Months
|
|
Reproductive system and breast disorders
Vaginal scarring
|
0.00%
0/90 • 36 Months
|
4.3%
4/93 • Number of events 4 • 36 Months
|
|
Reproductive system and breast disorders
Vaginotomy
|
1.1%
1/90 • Number of events 1 • 36 Months
|
1.1%
1/93 • Number of events 1 • 36 Months
|
|
Reproductive system and breast disorders
Vulvovaginal adhesion
|
2.2%
2/90 • Number of events 2 • 36 Months
|
1.1%
1/93 • Number of events 1 • 36 Months
|
|
Reproductive system and breast disorders
Vulvovaginal discomfort
|
1.1%
1/90 • Number of events 1 • 36 Months
|
0.00%
0/93 • 36 Months
|
|
Reproductive system and breast disorders
Vulvovaginal pain
|
3.3%
3/90 • Number of events 3 • 36 Months
|
0.00%
0/93 • 36 Months
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
1.1%
1/90 • Number of events 1 • 36 Months
|
3.2%
3/93 • Number of events 3 • 36 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
1.1%
1/90 • Number of events 1 • 36 Months
|
0.00%
0/93 • 36 Months
|
|
Skin and subcutaneous tissue disorders
Excessive granulation tissue after 12 wks.
|
11.1%
10/90 • Number of events 10 • 36 Months
|
1.1%
1/93 • Number of events 1 • 36 Months
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.1%
1/90 • Number of events 1 • 36 Months
|
0.00%
0/93 • 36 Months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/90 • 36 Months
|
1.1%
1/93 • Number of events 1 • 36 Months
|
|
Surgical and medical procedures
Ureteral stent insertion
|
0.00%
0/90 • 36 Months
|
1.1%
1/93 • Number of events 1 • 36 Months
|
|
Vascular disorders
Phlebitis
|
1.1%
1/90 • Number of events 1 • 36 Months
|
0.00%
0/93 • 36 Months
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place