Trial Outcomes & Findings for Operations and Pelvic Muscle Training in the Management of Apical Support Loss: The OPTIMAL Trial (NCT NCT00597935)
NCT ID: NCT00597935
Last Updated: 2020-10-22
Results Overview
The absence of the following: (1) descent of the vaginal apex more than one-third into the vaginal canal; (2) anterior or posterior vaginal wall descent beyond the hymen; (3) bothersome vaginal bulge symptoms as indicated by an affirmative response to either 'Do you usually have a sensation of bulging or protrusion from the vaginal area?' or 'Do you usually have a bulge or something falling out that you can see or feel in the vaginal area?' in the Pelvic Floor Distress Inventory and any response other than 'not at all' to the question 'How much does this bother you?'; or (4) re-treatment for prolapse by either surgery or pessary.
COMPLETED
NA
374 participants
24 months
2020-10-22
Participant Flow
Participant milestones
| Measure |
SSLF+BPMT
Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training
|
SSLF+USUAL
Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
|
ULS+BPMT
Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training
|
ULS+USUAL
Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
|
|---|---|---|---|---|
|
Randomized to Surgical and BPMT Arms
STARTED
|
95
|
91
|
91
|
97
|
|
Randomized to Surgical and BPMT Arms
COMPLETED
|
95
|
91
|
91
|
97
|
|
Randomized to Surgical and BPMT Arms
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Baseline to 6-Months
STARTED
|
95
|
91
|
91
|
97
|
|
Baseline to 6-Months
COMPLETED
|
93
|
87
|
87
|
93
|
|
Baseline to 6-Months
NOT COMPLETED
|
2
|
4
|
4
|
4
|
|
6-Months to 24-Months
STARTED
|
93
|
87
|
87
|
93
|
|
6-Months to 24-Months
COMPLETED
|
76
|
79
|
77
|
85
|
|
6-Months to 24-Months
NOT COMPLETED
|
17
|
8
|
10
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Operations and Pelvic Muscle Training in the Management of Apical Support Loss: The OPTIMAL Trial
Baseline characteristics by cohort
| Measure |
SSLF+BPMT
n=95 Participants
Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training
|
SSLF+USUAL
n=91 Participants
Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
|
ULS+BPMT
n=91 Participants
Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training
|
ULS+USUAL
n=97 Participants
Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
|
Total
n=374 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Connective tissue disease
.
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Connective tissue disease
No
|
93 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
91 Participants
n=4 Participants
|
364 Participants
n=21 Participants
|
|
Age, Continuous
|
56.3 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
58.1 years
STANDARD_DEVIATION 10.7 • n=7 Participants
|
58.7 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
55.8 years
STANDARD_DEVIATION 11 • n=4 Participants
|
57.2 years
STANDARD_DEVIATION 10.9 • n=21 Participants
|
|
Sex/Gender, Customized
Female
|
95 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
97 Participants
n=4 Participants
|
374 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
80 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
84 Participants
n=4 Participants
|
315 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latina
|
19 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
75 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic/Latina
|
76 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
75 Participants
n=4 Participants
|
299 Participants
n=21 Participants
|
|
Insurance: Private/HMO
No
|
33 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
123 Participants
n=21 Participants
|
|
Insurance: Private/HMO
Yes
|
62 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
251 Participants
n=21 Participants
|
|
Insurance: Medicare or Medicaid
No
|
68 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
70 Participants
n=4 Participants
|
265 Participants
n=21 Participants
|
|
Insurance: Medicare or Medicaid
Yes
|
27 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
109 Participants
n=21 Participants
|
|
Insurance: Self-pay
No
|
93 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
95 Participants
n=4 Participants
|
368 Participants
n=21 Participants
|
|
Insurance: Self-pay
Yes
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Insurance: Other
No
|
77 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
75 Participants
n=4 Participants
|
302 Participants
n=21 Participants
|
|
Insurance: Other
Yes
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
72 Participants
n=21 Participants
|
|
Body Mass Index
|
30 kg/m^2
STANDARD_DEVIATION 6.2 • n=5 Participants
|
28 kg/m^2
STANDARD_DEVIATION 5.1 • n=7 Participants
|
28.6 kg/m^2
STANDARD_DEVIATION 4.9 • n=5 Participants
|
28.8 kg/m^2
STANDARD_DEVIATION 5.5 • n=4 Participants
|
28.8 kg/m^2
STANDARD_DEVIATION 5.5 • n=21 Participants
|
|
Current Smoker
No
|
84 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
91 Participants
n=4 Participants
|
341 Participants
n=21 Participants
|
|
Current Smoker
Yes
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
|
Diabetes
.
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Diabetes
No
|
78 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
87 Participants
n=4 Participants
|
322 Participants
n=21 Participants
|
|
Diabetes
Yes
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
44 Participants
n=21 Participants
|
|
Connective tissue disease
Yes
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 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
|
3 Number of deliveries
n=4 Participants
|
3 Number of deliveries
n=21 Participants
|
|
Number of Cesarean Deliveries
|
0 Number of deliveries
n=5 Participants
|
0 Number of deliveries
n=7 Participants
|
0 Number of deliveries
n=5 Participants
|
0 Number of deliveries
n=4 Participants
|
0 Number of deliveries
n=21 Participants
|
|
Estrogen Use: Oral or patch
No
|
84 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
88 Participants
n=4 Participants
|
328 Participants
n=21 Participants
|
|
Estrogen Use: Oral or patch
Yes
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
46 Participants
n=21 Participants
|
|
Estrogen Use: Vaginal
No
|
77 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
286 Participants
n=21 Participants
|
|
Estrogen Use: Vaginal
Yes
|
18 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
88 Participants
n=21 Participants
|
|
Menstrual Status
Not sure
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Menstrual Status
Postmenopausal
|
59 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
246 Participants
n=21 Participants
|
|
Menstrual Status
Premenopausal
|
29 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
106 Participants
n=21 Participants
|
|
Hysterectomy
No
|
73 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
274 Participants
n=21 Participants
|
|
Hysterectomy
Yes
|
22 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
100 Participants
n=21 Participants
|
|
Prior Stress Urinary Incontinence Surgery
No
|
93 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
94 Participants
n=4 Participants
|
361 Participants
n=21 Participants
|
|
Prior Stress Urinary Incontinence Surgery
Yes
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Prior Pelvic Organ Prolapse Surgery
No
|
89 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
91 Participants
n=4 Participants
|
348 Participants
n=21 Participants
|
|
Prior Pelvic Organ Prolapse Surgery
Yes
|
6 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
|
Pelvic Organ Prolapse-Q stage
2
|
37 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
144 Participants
n=21 Participants
|
|
Pelvic Organ Prolapse-Q stage
3
|
54 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
212 Participants
n=21 Participants
|
|
Pelvic Organ Prolapse-Q stage
4
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: This outcome is analyzed in participants randomized to both surgical and behavioral interventions who had non-missing data for this 24-month outcome. There are minor differences between the Number of Participants Analyzed and the 24-month numbers in the Participant Flow module because of missing data.
The absence of the following: (1) descent of the vaginal apex more than one-third into the vaginal canal; (2) anterior or posterior vaginal wall descent beyond the hymen; (3) bothersome vaginal bulge symptoms as indicated by an affirmative response to either 'Do you usually have a sensation of bulging or protrusion from the vaginal area?' or 'Do you usually have a bulge or something falling out that you can see or feel in the vaginal area?' in the Pelvic Floor Distress Inventory and any response other than 'not at all' to the question 'How much does this bother you?'; or (4) re-treatment for prolapse by either surgery or pessary.
Outcome measures
| Measure |
SSLF+BPMT
n=72 Participants
Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training
|
SSLF+USUAL
n=77 Participants
Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
|
ULS+BPMT
n=73 Participants
Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training
|
ULS+USUAL
n=82 Participants
Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
|
|---|---|---|---|---|
|
Surgical Success
Failure
|
25 Participants
|
30 Participants
|
28 Participants
|
27 Participants
|
|
Surgical Success
Success
|
47 Participants
|
47 Participants
|
45 Participants
|
55 Participants
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: This outcome is analyzed in participants randomized to both surgical and behavioral interventions and who were in the study at 24 months.
Anatomic failure is defined by one of the following: descent of the vaginal apex more than one-third into the vaginal canal, anterior or posterior vaginal wall descent beyond the hymen, or re-treatment for prolapse.
Outcome measures
| Measure |
SSLF+BPMT
n=76 Participants
Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training
|
SSLF+USUAL
n=79 Participants
Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
|
ULS+BPMT
n=77 Participants
Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training
|
ULS+USUAL
n=85 Participants
Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
|
|---|---|---|---|---|
|
Anatomic Failure
Failure
|
18 Participants
|
23 Participants
|
19 Participants
|
19 Participants
|
|
Anatomic Failure
Non-failure
|
58 Participants
|
56 Participants
|
58 Participants
|
66 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: This outcome is analyzed in participants randomized to both surgical and behavioral interventions who had non-missing data for this 6-month outcome. There are minor differences between the Number of Participants Analyzed and the 6-month numbers in the Participant Flow module because of missing data.
The Pelvic Floor Distress Inventory is a validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of 3 scales: 1. Pelvic Organ Prolapse Distress Inventory (POPDI, with 3 subscales), 2. Colorectal Anal Distress Inventory (CRADI, with 4 subscales), and 3. Urinary Distress Inventory (UDI, with 3 subscales). Scores are calculated by multiplying the mean value of all questions answered by 25 for the subscales and then adding the subscales. The range of responses for the UDI is: 0-300 with 0 (least distress) to 300 (most distress). Lower scores indicate better function / fewer symptoms.
Outcome measures
| Measure |
SSLF+BPMT
n=87 Participants
Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training
|
SSLF+USUAL
n=83 Participants
Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
|
ULS+BPMT
n=83 Participants
Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training
|
ULS+USUAL
n=88 Participants
Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
|
|---|---|---|---|---|
|
Urinary Distress Inventory at 6 Months
|
30.6 units on a scale
Interval 22.8 to 38.5
|
37.9 units on a scale
Interval 27.0 to 48.8
|
27.4 units on a scale
Interval 19.1 to 35.7
|
29.7 units on a scale
Interval 21.3 to 38.1
|
SECONDARY outcome
Timeframe: Baseline and 24 monthsPopulation: This outcome is analyzed in participants randomized to both surgical and behavioral interventions who had non-missing data for this 24-month outcome. There are differences between the Number of Participants Analyzed and the 24-month numbers in the Participant Flow module because of missing data.
The Pelvic Floor Distress Inventory is a validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of 3 scales: 1. Pelvic Organ Prolapse Distress Inventory (POPDI, with 3 subscales), 2. Colorectal Anal Distress Inventory (CRADI, with 4 subscales), and 3. Urinary Distress Inventory (UDI, with 3 subscales). Scores are calculated by multiplying the mean value of all questions answered by 25 for the subscales and then adding the subscales. The range of responses for the UDI is: 0-300 with 0 (least distress) to 300 (most distress). Change = (24 Month Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
Outcome measures
| Measure |
SSLF+BPMT
n=76 Participants
Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training
|
SSLF+USUAL
n=72 Participants
Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
|
ULS+BPMT
n=70 Participants
Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training
|
ULS+USUAL
n=74 Participants
Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
|
|---|---|---|---|---|
|
Change From Baseline: Urinary Distress Inventory
|
-88.1 units on a scale
Interval -104.4 to -71.8
|
-84.9 units on a scale
Interval -99.3 to -70.5
|
-82.5 units on a scale
Interval -98.1 to -66.9
|
-82.9 units on a scale
Interval -97.0 to -68.8
|
SECONDARY outcome
Timeframe: Baseline and 24 monthsPopulation: This outcome is analyzed in participants randomized to both surgical and behavioral interventions who had non-missing data for this 24-month outcome. There are differences between the Number of Participants Analyzed and the 24-month numbers in the Participant Flow module because of missing data.
The Pelvic Floor Distress Inventory is a validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of 3 scales: 1. Pelvic Organ Prolapse Distress Inventory (POPDI, with 3 subscales), 2. Colorectal Anal Distress Inventory (CRADI, with 4 subscales), and 3. Urinary Distress Inventory (UDI, with 3 subscales). Scores are calculated by multiplying the mean value of all questions answered by 25 for the subscales and then adding the subscales. The range of responses for the POPDI is: 0-300 with 0 (least distress) to 300 (most distress). Change = (24 Month Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
Outcome measures
| Measure |
SSLF+BPMT
n=76 Participants
Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training
|
SSLF+USUAL
n=72 Participants
Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
|
ULS+BPMT
n=70 Participants
Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training
|
ULS+USUAL
n=74 Participants
Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
|
|---|---|---|---|---|
|
Change From Baseline: Pelvic Organ Prolapse Distress Inventory
|
-77.4 units on a scale
Interval -93.7 to -61.1
|
-70.6 units on a scale
Interval -87.9 to -53.4
|
-79.3 units on a scale
Interval -96.6 to -62.0
|
-66.4 units on a scale
Interval -80.8 to -52.1
|
SECONDARY outcome
Timeframe: Baseline and 24 monthsPopulation: This outcome is analyzed in participants randomized to both surgical and behavioral interventions who had non-missing data for this 24-month outcome. There are differences between the Number of Participants Analyzed and the 24-month numbers in the Participant Flow module because of missing data.
The Pelvic Floor Distress Inventory is a validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of 3 scales: 1. Pelvic Organ Prolapse Distress Inventory (POPDI, with 3 subscales), 2. Colorectal Anal Distress Inventory (CRADI, with 4 subscales), and 3. Urinary Distress Inventory (UDI, with 3 subscales). Scores are calculated by multiplying the mean value of all questions answered by 25 for the subscales and then adding the subscales. The range of responses for the CRADI is: 0-400 with 0 (least distress) to 400 (most distress). Change = (24 Month Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
Outcome measures
| Measure |
SSLF+BPMT
n=76 Participants
Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training
|
SSLF+USUAL
n=72 Participants
Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
|
ULS+BPMT
n=70 Participants
Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training
|
ULS+USUAL
n=74 Participants
Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
|
|---|---|---|---|---|
|
Change From Baseline: Colorectal Anal Distress Inventory
|
-48.6 units on a scale
Interval -68.9 to -28.2
|
-46.5 units on a scale
Interval -66.1 to -26.8
|
-61.4 units on a scale
Interval -78.6 to -44.2
|
-52.4 units on a scale
Interval -70.2 to -34.7
|
SECONDARY outcome
Timeframe: Baseline and 24 monthsPopulation: This outcome is analyzed in participants randomized to both surgical and behavioral interventions who had non-missing data for this 24-month outcome. There are differences between the Number of Participants Analyzed and the 24-month numbers in the Participant Flow module because of missing data.
The Pelvic Floor Impact Questionnaire measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales: the Urinary Impact Questionnaire (UIQ; 4 subscales, range 0-400), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; 4 subscales, range 0-400), and the Colorectal-Anal Impact Questionnaire (CRAIQ; 4 subscales, range 0-400). Scores are calculated by multiplying the mean value of all answered questions for a subscale by 100 divided by 3. The subscales are then added together. The range of responses is: 0-400 with 0 (least negative impact) to 400 (most negative impact). Change = (24 Month Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
Outcome measures
| Measure |
SSLF+BPMT
n=76 Participants
Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training
|
SSLF+USUAL
n=72 Participants
Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
|
ULS+BPMT
n=70 Participants
Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training
|
ULS+USUAL
n=74 Participants
Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
|
|---|---|---|---|---|
|
Urinary Impact Questionnaire Change From Baseline to 24 Months
|
-84 units on a scale
Interval -110.4 to -57.7
|
-72.6 units on a scale
Interval -94.4 to -50.8
|
-79 units on a scale
Interval -104.3 to -53.7
|
-97.6 units on a scale
Interval -119.5 to -75.8
|
SECONDARY outcome
Timeframe: Baseline and 24 monthsPopulation: This outcome is analyzed in participants randomized to both surgical and behavioral interventions who had non-missing data for this 24-month outcome. There are differences between the Number of Participants Analyzed and the 24-month numbers in the Participant Flow module because of missing data.
The Pelvic Floor Impact Questionnaire measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales: the Urinary Impact Questionnaire (UIQ; 4 subscales, range 0-400), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; 4 subscales, range 0-400), and the Colorectal-Anal Impact Questionnaire (CRAIQ; 4 subscales, range 0-400). Scores are calculated by multiplying the mean value of all answered questions for a subscale by 100 divided by 3. The subscales are then added together. The range of responses is: 0-400 with 0 (least negative impact) to 400 (most negative impact). Change = (Year 2 Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
Outcome measures
| Measure |
SSLF+BPMT
n=76 Participants
Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training
|
SSLF+USUAL
n=73 Participants
Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
|
ULS+BPMT
n=70 Participants
Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training
|
ULS+USUAL
n=76 Participants
Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
|
|---|---|---|---|---|
|
Pelvic Organ Prolapse Impact Questionnaire Change From Baseline to 24 Months
|
-67.5 units on a scale
Interval -94.6 to -40.4
|
-49.1 units on a scale
Interval -70.9 to -27.3
|
-59.4 units on a scale
Interval -86.1 to -32.6
|
-82.2 units on a scale
Interval -103.7 to -60.7
|
SECONDARY outcome
Timeframe: Baseline and 24 monthsPopulation: This outcome is analyzed in participants randomized to both surgical and behavioral interventions who had non-missing data for this 24-month outcome. There are differences between the Number of Participants Analyzed and the 24-month numbers in the Participant Flow module because of missing data.
The Pelvic Floor Impact Questionnaire measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales: the Urinary Impact Questionnaire (UIQ; 4 subscales, range 0-400), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; 4 subscales, range 0-400), and the Colorectal-Anal Impact Questionnaire (CRAIQ; 4 subscales, range 0-400). Scores are calculated by multiplying the mean value of all answered questions for a subscale by 100 divided by 3. The subscales are then added together. The range of responses is: 0-400 with 0 (least negative impact) to 400 (most negative impact). Change = (Year 2 Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
Outcome measures
| Measure |
SSLF+BPMT
n=76 Participants
Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training
|
SSLF+USUAL
n=73 Participants
Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
|
ULS+BPMT
n=70 Participants
Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training
|
ULS+USUAL
n=76 Participants
Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
|
|---|---|---|---|---|
|
Colorectal-Anal Impact Questionnaire Change From Baseline to 24 Months
|
-40.9 units on a scale
Interval -67.8 to -14.0
|
-21.6 units on a scale
Interval -41.8 to -1.4
|
-29.2 units on a scale
Interval -54.0 to -4.3
|
-42.5 units on a scale
Interval -60.7 to -24.2
|
SECONDARY outcome
Timeframe: Baseline and 24 monthsPopulation: This outcome is analyzed in participants randomized to both surgical and behavioral interventions who had non-missing data for this 24-month outcome. There are differences between the Number of Participants Analyzed and the 24-month numbers in the Participant Flow module because of missing data.
Sexual Function 36 (SF36) - Physical Health Component Score is the physical health component of the Sexual Function 36 survey with scores ranging from 0 to 100 with higher scores meaning a better health state. Scales are scored according to the algorithm that describes the handling of the various types of questions included in the questionnaire. Several steps are involved in the scoring process: recoding items that require it; summing over items; and transforming raw scale scores to a 0 to 100 scale. This physical health component is a function of several constructs measured under the SF36: physical functioning, physical role, bodily pain, general health, and vitality.
Outcome measures
| Measure |
SSLF+BPMT
n=75 Participants
Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training
|
SSLF+USUAL
n=71 Participants
Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
|
ULS+BPMT
n=71 Participants
Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training
|
ULS+USUAL
n=75 Participants
Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
|
|---|---|---|---|---|
|
Sexual Function 36 - Physical Health Component Score Change From Baseline to 24 Months
|
7.9 units on a scale
Interval 5.3 to 10.4
|
4.8 units on a scale
Interval 2.4 to 7.2
|
4.8 units on a scale
Interval 2.6 to 6.9
|
6 units on a scale
Interval 4.0 to 7.9
|
SECONDARY outcome
Timeframe: Baseline and 24 monthsPopulation: This outcome is analyzed in participants randomized to both surgical and behavioral interventions who had non-missing data for this 24-month outcome. There are differences between the Number of Participants Analyzed and the 24-month numbers in the Participant Flow module because of missing data.
Sexual Function 36 (SF36) - Mental Health Component Score is the mental health component of the Sexual Function 36 survey with scores ranging from 0 to 100 with higher scores meaning a better health state. Scales are scored according to the algorithm that describes the handling of the various types of questions included in the questionnaire. Several steps are involved in the scoring process: recoding items that require it; summing over items; and transforming raw scale scores to a 0 to 100 scale.
Outcome measures
| Measure |
SSLF+BPMT
n=75 Participants
Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training
|
SSLF+USUAL
n=71 Participants
Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
|
ULS+BPMT
n=71 Participants
Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training
|
ULS+USUAL
n=75 Participants
Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
|
|---|---|---|---|---|
|
Sexual Function 36 - Mental Health Component Score Change From Baseline to 24 Months
|
0.6 units on a scale
Interval -2.2 to 3.4
|
2 units on a scale
Interval -0.3 to 4.2
|
2.5 units on a scale
Interval 0.0 to 5.0
|
1.1 units on a scale
Interval -1.7 to 4.0
|
SECONDARY outcome
Timeframe: Baseline and 24 monthsPopulation: This outcome is analyzed in participants randomized to both surgical and behavioral interventions who had non-missing data for this 24-month outcome. There are differences between the Number of Participants Analyzed and the 24-month numbers in the Participant Flow module because of missing data.
Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ) is a survey of sexual functioning with scores ranging from 0 to 48 with higher scores meaning better sexual functioning. Patients were asked to answer 31 questions about their sexuality in the past 6 months.
Outcome measures
| Measure |
SSLF+BPMT
n=35 Participants
Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training
|
SSLF+USUAL
n=25 Participants
Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
|
ULS+BPMT
n=27 Participants
Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training
|
ULS+USUAL
n=37 Participants
Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
|
|---|---|---|---|---|
|
Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire Change From Baseline to 24 Months
|
5.6 units on a scale
Interval 3.0 to 8.2
|
4.6 units on a scale
Interval 1.4 to 7.8
|
3.8 units on a scale
Interval 0.9 to 6.6
|
6.6 units on a scale
Interval 4.2 to 9.1
|
Adverse Events
ULS+BPMT
SSLF+BPMT
ULS+USUAL
SSLF+USUAL
Serious adverse events
| Measure |
ULS+BPMT
n=91 participants at risk
Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training
|
SSLF+BPMT
n=95 participants at risk
Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training
|
ULS+USUAL
n=97 participants at risk
Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
|
SSLF+USUAL
n=91 participants at risk
Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
|
|---|---|---|---|---|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/91 • 24 Months
|
0.00%
0/95 • 24 Months
|
1.0%
1/97 • Number of events 1 • 24 Months
|
0.00%
0/91 • 24 Months
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/91 • 24 Months
|
0.00%
0/95 • 24 Months
|
0.00%
0/97 • 24 Months
|
1.1%
1/91 • Number of events 1 • 24 Months
|
|
Cardiac disorders
Angina unstable
|
1.1%
1/91 • Number of events 1 • 24 Months
|
0.00%
0/95 • 24 Months
|
0.00%
0/97 • 24 Months
|
0.00%
0/91 • 24 Months
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/91 • 24 Months
|
0.00%
0/95 • 24 Months
|
1.0%
1/97 • Number of events 1 • 24 Months
|
0.00%
0/91 • 24 Months
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/91 • 24 Months
|
1.1%
1/95 • Number of events 1 • 24 Months
|
0.00%
0/97 • 24 Months
|
0.00%
0/91 • 24 Months
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/91 • 24 Months
|
0.00%
0/95 • 24 Months
|
1.0%
1/97 • Number of events 2 • 24 Months
|
0.00%
0/91 • 24 Months
|
|
Gastrointestinal disorders
Faecaloma
|
1.1%
1/91 • Number of events 1 • 24 Months
|
0.00%
0/95 • 24 Months
|
0.00%
0/97 • 24 Months
|
0.00%
0/91 • 24 Months
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/91 • 24 Months
|
0.00%
0/95 • 24 Months
|
1.0%
1/97 • Number of events 1 • 24 Months
|
0.00%
0/91 • 24 Months
|
|
Gastrointestinal disorders
Hiatal Hernia
|
0.00%
0/91 • 24 Months
|
0.00%
0/95 • 24 Months
|
0.00%
0/97 • 24 Months
|
1.1%
1/91 • Number of events 1 • 24 Months
|
|
Gastrointestinal disorders
Oesophageal achalasia
|
0.00%
0/91 • 24 Months
|
0.00%
0/95 • 24 Months
|
0.00%
0/97 • 24 Months
|
1.1%
1/91 • Number of events 1 • 24 Months
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
1/91 • Number of events 1 • 24 Months
|
0.00%
0/95 • 24 Months
|
0.00%
0/97 • 24 Months
|
0.00%
0/91 • 24 Months
|
|
General disorders
Chest Pain
|
0.00%
0/91 • 24 Months
|
0.00%
0/95 • 24 Months
|
1.0%
1/97 • Number of events 1 • 24 Months
|
0.00%
0/91 • 24 Months
|
|
General disorders
Fever
|
1.1%
1/91 • Number of events 1 • 24 Months
|
0.00%
0/95 • 24 Months
|
0.00%
0/97 • 24 Months
|
0.00%
0/91 • 24 Months
|
|
General disorders
Gastrointestinal haemorrhage
|
0.00%
0/91 • 24 Months
|
0.00%
0/95 • 24 Months
|
1.0%
1/97 • Number of events 1 • 24 Months
|
0.00%
0/91 • 24 Months
|
|
General disorders
Suprapubic pain
|
0.00%
0/91 • 24 Months
|
0.00%
0/95 • 24 Months
|
0.00%
0/97 • 24 Months
|
1.1%
1/91 • Number of events 1 • 24 Months
|
|
General disorders
Unable to determine Preferred Term
|
1.1%
1/91 • Number of events 1 • 24 Months
|
1.1%
1/95 • Number of events 1 • 24 Months
|
0.00%
0/97 • 24 Months
|
0.00%
0/91 • 24 Months
|
|
Hepatobiliary disorders
Biliary cholic
|
1.1%
1/91 • Number of events 1 • 24 Months
|
0.00%
0/95 • 24 Months
|
0.00%
0/97 • 24 Months
|
0.00%
0/91 • 24 Months
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.00%
0/91 • 24 Months
|
0.00%
0/95 • 24 Months
|
0.00%
0/97 • 24 Months
|
1.1%
1/91 • Number of events 1 • 24 Months
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/91 • 24 Months
|
0.00%
0/95 • 24 Months
|
1.0%
1/97 • Number of events 1 • 24 Months
|
0.00%
0/91 • 24 Months
|
|
Hepatobiliary disorders
Non-alcoholic steatohepatitis
|
0.00%
0/91 • 24 Months
|
0.00%
0/95 • 24 Months
|
1.0%
1/97 • Number of events 2 • 24 Months
|
0.00%
0/91 • 24 Months
|
|
Immune system disorders
Allergic Reaction
|
0.00%
0/91 • 24 Months
|
0.00%
0/95 • 24 Months
|
0.00%
0/97 • 24 Months
|
1.1%
1/91 • Number of events 1 • 24 Months
|
|
Infections and infestations
Cholecystitis infective
|
1.1%
1/91 • Number of events 1 • 24 Months
|
0.00%
0/95 • 24 Months
|
0.00%
0/97 • 24 Months
|
0.00%
0/91 • 24 Months
|
|
Infections and infestations
DIVERTICULITIS
|
1.1%
1/91 • Number of events 1 • 24 Months
|
0.00%
0/95 • 24 Months
|
1.0%
1/97 • Number of events 2 • 24 Months
|
0.00%
0/91 • 24 Months
|
|
Infections and infestations
Pelvic abscess
|
0.00%
0/91 • 24 Months
|
1.1%
1/95 • Number of events 1 • 24 Months
|
0.00%
0/97 • 24 Months
|
0.00%
0/91 • 24 Months
|
|
Infections and infestations
Pneumonia
|
1.1%
1/91 • Number of events 1 • 24 Months
|
0.00%
0/95 • 24 Months
|
1.0%
1/97 • Number of events 1 • 24 Months
|
0.00%
0/91 • 24 Months
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/91 • 24 Months
|
1.1%
1/95 • Number of events 1 • 24 Months
|
0.00%
0/97 • 24 Months
|
1.1%
1/91 • Number of events 1 • 24 Months
|
|
Infections and infestations
Unable to determine Preferred Term
|
0.00%
0/91 • 24 Months
|
0.00%
0/95 • 24 Months
|
0.00%
0/97 • 24 Months
|
1.1%
1/91 • Number of events 1 • 24 Months
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/91 • 24 Months
|
0.00%
0/95 • 24 Months
|
0.00%
0/97 • 24 Months
|
1.1%
1/91 • Number of events 1 • 24 Months
|
|
Infections and infestations
Vaginal Abscess
|
0.00%
0/91 • 24 Months
|
0.00%
0/95 • 24 Months
|
0.00%
0/97 • 24 Months
|
1.1%
1/91 • Number of events 1 • 24 Months
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.00%
0/91 • 24 Months
|
0.00%
0/95 • 24 Months
|
0.00%
0/97 • 24 Months
|
1.1%
1/91 • Number of events 1 • 24 Months
|
|
Injury, poisoning and procedural complications
Bladder injury
|
0.00%
0/91 • 24 Months
|
0.00%
0/95 • 24 Months
|
1.0%
1/97 • Number of events 1 • 24 Months
|
0.00%
0/91 • 24 Months
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/91 • 24 Months
|
0.00%
0/95 • 24 Months
|
0.00%
0/97 • 24 Months
|
1.1%
1/91 • Number of events 1 • 24 Months
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/91 • 24 Months
|
0.00%
0/95 • 24 Months
|
0.00%
0/97 • 24 Months
|
1.1%
1/91 • Number of events 1 • 24 Months
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
0.00%
0/91 • 24 Months
|
0.00%
0/95 • 24 Months
|
1.0%
1/97 • Number of events 1 • 24 Months
|
0.00%
0/91 • 24 Months
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/91 • 24 Months
|
0.00%
0/95 • 24 Months
|
0.00%
0/97 • 24 Months
|
1.1%
1/91 • Number of events 1 • 24 Months
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/91 • 24 Months
|
0.00%
0/95 • 24 Months
|
0.00%
0/97 • 24 Months
|
1.1%
1/91 • Number of events 1 • 24 Months
|
|
Investigations
PO2 decreased
|
0.00%
0/91 • 24 Months
|
0.00%
0/95 • 24 Months
|
0.00%
0/97 • 24 Months
|
1.1%
1/91 • Number of events 1 • 24 Months
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/91 • 24 Months
|
0.00%
0/95 • 24 Months
|
1.0%
1/97 • Number of events 2 • 24 Months
|
0.00%
0/91 • 24 Months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/91 • 24 Months
|
0.00%
0/95 • 24 Months
|
1.0%
1/97 • Number of events 1 • 24 Months
|
0.00%
0/91 • 24 Months
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/91 • 24 Months
|
0.00%
0/95 • 24 Months
|
0.00%
0/97 • 24 Months
|
1.1%
1/91 • Number of events 1 • 24 Months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/91 • 24 Months
|
0.00%
0/95 • 24 Months
|
0.00%
0/97 • 24 Months
|
1.1%
1/91 • Number of events 1 • 24 Months
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/91 • 24 Months
|
1.1%
1/95 • Number of events 3 • 24 Months
|
0.00%
0/97 • 24 Months
|
0.00%
0/91 • 24 Months
|
|
Musculoskeletal and connective tissue disorders
Pain in Leg
|
0.00%
0/91 • 24 Months
|
0.00%
0/95 • 24 Months
|
0.00%
0/97 • 24 Months
|
1.1%
1/91 • Number of events 1 • 24 Months
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/91 • 24 Months
|
0.00%
0/95 • 24 Months
|
0.00%
0/97 • 24 Months
|
1.1%
1/91 • Number of events 1 • 24 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
1.1%
1/91 • Number of events 1 • 24 Months
|
0.00%
0/95 • 24 Months
|
0.00%
0/97 • 24 Months
|
0.00%
0/91 • 24 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer stage II
|
1.1%
1/91 • Number of events 2 • 24 Months
|
0.00%
0/95 • 24 Months
|
0.00%
0/97 • 24 Months
|
0.00%
0/91 • 24 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitonal cell carcinoma
|
1.1%
1/91 • Number of events 1 • 24 Months
|
0.00%
0/95 • 24 Months
|
0.00%
0/97 • 24 Months
|
0.00%
0/91 • 24 Months
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/91 • 24 Months
|
1.1%
1/95 • Number of events 1 • 24 Months
|
0.00%
0/97 • 24 Months
|
0.00%
0/91 • 24 Months
|
|
Nervous system disorders
Pudenal canal syndrome
|
0.00%
0/91 • 24 Months
|
1.1%
1/95 • Number of events 1 • 24 Months
|
0.00%
0/97 • 24 Months
|
0.00%
0/91 • 24 Months
|
|
Nervous system disorders
Sciatic nerve neuropathy
|
0.00%
0/91 • 24 Months
|
1.1%
1/95 • Number of events 1 • 24 Months
|
0.00%
0/97 • 24 Months
|
0.00%
0/91 • 24 Months
|
|
Nervous system disorders
Syncope
|
0.00%
0/91 • 24 Months
|
1.1%
1/95 • Number of events 1 • 24 Months
|
0.00%
0/97 • 24 Months
|
0.00%
0/91 • 24 Months
|
|
Psychiatric disorders
Completed suicide
|
1.1%
1/91 • Number of events 1 • 24 Months
|
0.00%
0/95 • 24 Months
|
0.00%
0/97 • 24 Months
|
0.00%
0/91 • 24 Months
|
|
Psychiatric disorders
Depression Suicidal
|
0.00%
0/91 • 24 Months
|
0.00%
0/95 • 24 Months
|
1.0%
1/97 • Number of events 1 • 24 Months
|
0.00%
0/91 • 24 Months
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/91 • 24 Months
|
1.1%
1/95 • Number of events 1 • 24 Months
|
0.00%
0/97 • 24 Months
|
0.00%
0/91 • 24 Months
|
|
Renal and urinary disorders
Hydronephrosis
|
1.1%
1/91 • Number of events 1 • 24 Months
|
1.1%
1/95 • Number of events 1 • 24 Months
|
0.00%
0/97 • 24 Months
|
0.00%
0/91 • 24 Months
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/91 • 24 Months
|
1.1%
1/95 • Number of events 1 • 24 Months
|
0.00%
0/97 • 24 Months
|
0.00%
0/91 • 24 Months
|
|
Reproductive system and breast disorders
Breast enlargement
|
0.00%
0/91 • 24 Months
|
0.00%
0/95 • 24 Months
|
0.00%
0/97 • 24 Months
|
1.1%
1/91 • Number of events 1 • 24 Months
|
|
Reproductive system and breast disorders
Haemorrhage
|
0.00%
0/91 • 24 Months
|
0.00%
0/95 • 24 Months
|
0.00%
0/97 • 24 Months
|
1.1%
1/91 • Number of events 1 • 24 Months
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/91 • 24 Months
|
0.00%
0/95 • 24 Months
|
1.0%
1/97 • Number of events 1 • 24 Months
|
0.00%
0/91 • 24 Months
|
|
Reproductive system and breast disorders
Ovarian vein thrombosis
|
0.00%
0/91 • 24 Months
|
0.00%
0/95 • 24 Months
|
0.00%
0/97 • 24 Months
|
1.1%
1/91 • Number of events 2 • 24 Months
|
|
Reproductive system and breast disorders
Pelvic prolapse
|
1.1%
1/91 • Number of events 1 • 24 Months
|
0.00%
0/95 • 24 Months
|
0.00%
0/97 • 24 Months
|
0.00%
0/91 • 24 Months
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/91 • 24 Months
|
0.00%
0/95 • 24 Months
|
1.0%
1/97 • Number of events 1 • 24 Months
|
0.00%
0/91 • 24 Months
|
|
Reproductive system and breast disorders
Vulvovaginal Pain
|
0.00%
0/91 • 24 Months
|
0.00%
0/95 • 24 Months
|
0.00%
0/97 • 24 Months
|
1.1%
1/91 • Number of events 2 • 24 Months
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/91 • 24 Months
|
1.1%
1/95 • Number of events 1 • 24 Months
|
0.00%
0/97 • 24 Months
|
0.00%
0/91 • 24 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.1%
1/91 • Number of events 1 • 24 Months
|
1.1%
1/95 • Number of events 1 • 24 Months
|
0.00%
0/97 • 24 Months
|
0.00%
0/91 • 24 Months
|
|
Surgical and medical procedures
Hiatus hernia
|
0.00%
0/91 • 24 Months
|
1.1%
1/95 • Number of events 1 • 24 Months
|
0.00%
0/97 • 24 Months
|
0.00%
0/91 • 24 Months
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.00%
0/91 • 24 Months
|
0.00%
0/95 • 24 Months
|
1.0%
1/97 • Number of events 3 • 24 Months
|
0.00%
0/91 • 24 Months
|
|
Surgical and medical procedures
Nephrectomy
|
0.00%
0/91 • 24 Months
|
1.1%
1/95 • Number of events 1 • 24 Months
|
0.00%
0/97 • 24 Months
|
0.00%
0/91 • 24 Months
|
|
Surgical and medical procedures
Prolapse repair
|
0.00%
0/91 • 24 Months
|
1.1%
1/95 • Number of events 1 • 24 Months
|
0.00%
0/97 • 24 Months
|
0.00%
0/91 • 24 Months
|
Other adverse events
| Measure |
ULS+BPMT
n=91 participants at risk
Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training
|
SSLF+BPMT
n=95 participants at risk
Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training
|
ULS+USUAL
n=97 participants at risk
Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
|
SSLF+USUAL
n=91 participants at risk
Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
|
|---|---|---|---|---|
|
General disorders
OTHER ADVERSE EVENTS
|
20.9%
19/91 • Number of events 19 • 24 Months
|
22.1%
21/95 • Number of events 21 • 24 Months
|
22.7%
22/97 • Number of events 22 • 24 Months
|
27.5%
25/91 • Number of events 25 • 24 Months
|
|
General disorders
MESH EROSION/EXPOSURE AT 4 WEEKS TO 24 MONTHS
|
2.2%
2/91 • Number of events 2 • 24 Months
|
1.1%
1/95 • Number of events 1 • 24 Months
|
1.0%
1/97 • Number of events 1 • 24 Months
|
0.00%
0/91 • 24 Months
|
|
General disorders
SUTURE EXPOSURE AT 6 TO 24 MONTHS
|
11.0%
10/91 • Number of events 10 • 24 Months
|
18.9%
18/95 • Number of events 18 • 24 Months
|
19.6%
19/97 • Number of events 19 • 24 Months
|
15.4%
14/91 • Number of events 14 • 24 Months
|
|
Injury, poisoning and procedural complications
BLADDER INJURY
|
12.1%
11/91 • Number of events 11 • 24 Months
|
10.5%
10/95 • Number of events 10 • 24 Months
|
11.3%
11/97 • Number of events 11 • 24 Months
|
8.8%
8/91 • Number of events 8 • 24 Months
|
|
Injury, poisoning and procedural complications
BLOOD TRANSFUSION
|
2.2%
2/91 • Number of events 2 • 24 Months
|
1.1%
1/95 • Number of events 1 • 24 Months
|
5.2%
5/97 • Number of events 5 • 24 Months
|
3.3%
3/91 • Number of events 3 • 24 Months
|
|
Injury, poisoning and procedural complications
INTRAOPERTIVE URETERAL INJURY
|
2.2%
2/91 • Number of events 2 • 24 Months
|
0.00%
0/95 • 24 Months
|
4.1%
4/97 • Number of events 4 • 24 Months
|
0.00%
0/91 • 24 Months
|
|
Injury, poisoning and procedural complications
RECTAL INJURY
|
0.00%
0/91 • 24 Months
|
0.00%
0/95 • 24 Months
|
0.00%
0/97 • 24 Months
|
1.1%
1/91 • Number of events 1 • 24 Months
|
|
Injury, poisoning and procedural complications
TREATMENT - STENT PLACEMENT
|
0.00%
0/91 • 24 Months
|
0.00%
0/95 • 24 Months
|
1.0%
1/97 • Number of events 1 • 24 Months
|
0.00%
0/91 • 24 Months
|
|
Injury, poisoning and procedural complications
TREATMENT - SUTURE REMOVED INTRAOPERATIVELY
|
2.2%
2/91 • Number of events 2 • 24 Months
|
0.00%
0/95 • 24 Months
|
3.1%
3/97 • Number of events 3 • 24 Months
|
0.00%
0/91 • 24 Months
|
|
Injury, poisoning and procedural complications
URETERAL INJURY - DELAYED RECOGNITION
|
1.1%
1/91 • Number of events 1 • 24 Months
|
0.00%
0/95 • 24 Months
|
0.00%
0/97 • 24 Months
|
0.00%
0/91 • 24 Months
|
|
Nervous system disorders
NEUROLOGIC PAIN REQUIRING TREATMENT
|
8.8%
8/91 • Number of events 8 • 24 Months
|
12.6%
12/95 • Number of events 12 • 24 Months
|
5.2%
5/97 • Number of events 5 • 24 Months
|
12.1%
11/91 • Number of events 11 • 24 Months
|
|
Skin and subcutaneous tissue disorders
VAGINAL GRANULATION TISSUE AT 6 TO 24 MONTHS
|
22.0%
20/91 • Number of events 20 • 24 Months
|
17.9%
17/95 • Number of events 17 • 24 Months
|
16.5%
16/97 • Number of events 16 • 24 Months
|
9.9%
9/91 • Number of events 9 • 24 Months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place