Trial Outcomes & Findings for Transobturator Verus Single Incision Slings (NCT NCT02599051)
NCT ID: NCT02599051
Last Updated: 2023-07-20
Results Overview
The primary outcome was presence of leakage during cough stress test(CST) on examination
COMPLETED
NA
98 participants
1 year
2023-07-20
Participant Flow
Participant milestones
| Measure |
Monarc
Placement of a transobturator monarc sling for stress urinary incontinence
Monarc: We will place a transobturator sling at the time of surgery for stress urinary incontinence
|
Mini-arc
Placement of a single incision mini-arc sling for stress urinary incontinence
Mini-arc: We will place a single incision sling at the time of surgery for stress urinary incontinence
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
49
|
|
Overall Study
COMPLETED
|
42
|
41
|
|
Overall Study
NOT COMPLETED
|
7
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Transobturator Verus Single Incision Slings
Baseline characteristics by cohort
| Measure |
Monarc
n=49 Participants
Placement of a transobturator monarc sling for stress urinary incontinence
Monarc: We will place a transobturator sling at the time of surgery for stress urinary incontinence
|
Mini-arc
n=49 Participants
Placement of a single incision mini-arc sling for stress urinary incontinence
Mini-arc: We will place a single incision sling at the time of surgery for stress urinary incontinence
|
Total
n=98 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
49 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
98 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
48.9 years
n=99 Participants
|
52.9 years
n=107 Participants
|
50 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
98 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
49 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
98 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 1 yearThe primary outcome was presence of leakage during cough stress test(CST) on examination
Outcome measures
| Measure |
Monarc
n=42 Participants
Placement of a transobturator monarc sling for stress urinary incontinence
Monarc: We will place a transobturator sling at the time of surgery for stress urinary incontinence
|
Mini-arc
n=41 Participants
Placement of a single incision mini-arc sling for stress urinary incontinence
Mini-arc: We will place a single incision sling at the time of surgery for stress urinary incontinence
|
|---|---|---|
|
Objective Stress Urinary Incontinence
|
9 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 1 yearResponse to validated questionnaire: Urinary Distress Index(UDI-6) Measures symptoms on three subscales: 1. Irritative 2. Stress 3. Obstructive/Discomfort. The mean value of all questions answered is then multiplied by 25 for the actual score (range 0 to 100) Summary score - Add the scores from the 3 scales together to obtain the summary score (range 0 to 300) The higher the score the greater the perceived impact that pelvic floor dysfunction has on a patient's life.
Outcome measures
| Measure |
Monarc
n=42 Participants
Placement of a transobturator monarc sling for stress urinary incontinence
Monarc: We will place a transobturator sling at the time of surgery for stress urinary incontinence
|
Mini-arc
n=41 Participants
Placement of a single incision mini-arc sling for stress urinary incontinence
Mini-arc: We will place a single incision sling at the time of surgery for stress urinary incontinence
|
|---|---|---|
|
Quality of Life Questionnaire UDI-6
|
15.1 score on a scale
Standard Deviation 16.4
|
20.3 score on a scale
Standard Deviation 20.4
|
SECONDARY outcome
Timeframe: 1 yearAssess if the patient has any complaint of stress urinary incontinence after surgery in follow up visits. This will be history only, no examination.
Outcome measures
| Measure |
Monarc
n=42 Participants
Placement of a transobturator monarc sling for stress urinary incontinence
Monarc: We will place a transobturator sling at the time of surgery for stress urinary incontinence
|
Mini-arc
n=41 Participants
Placement of a single incision mini-arc sling for stress urinary incontinence
Mini-arc: We will place a single incision sling at the time of surgery for stress urinary incontinence
|
|---|---|---|
|
Subjective Patient Reported Recurrent or Persistent Stress Urinary Incontinence
|
11 participants
|
21 participants
|
SECONDARY outcome
Timeframe: 1 yearSelf-assessment of cure is based on 5 point scale, cured, greatly improved, somewhat improved, not improved, and worsened. This is calculated by the number of patients that were analyzed.
Outcome measures
| Measure |
Monarc
n=42 Participants
Placement of a transobturator monarc sling for stress urinary incontinence
Monarc: We will place a transobturator sling at the time of surgery for stress urinary incontinence
|
Mini-arc
n=41 Participants
Placement of a single incision mini-arc sling for stress urinary incontinence
Mini-arc: We will place a single incision sling at the time of surgery for stress urinary incontinence
|
|---|---|---|
|
Number of Participants Who Completed Self- Assessment of Cure
|
37 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: 1 yearResponse to validated questionnaire: Incontinence Impact Questionnaire(IIQ-7) The IIQ measures the impact of urinary incontinence on activities roles, and emotional states. A mean score is derived from each domain, then transferred to give weight to each subscale. Subscale scores range from 0-100. The total IIQ score is calculated by adding the four subscales score with a range of 0-400 possible. A score closer to 0 represents activities not affected at all versus closer to 400 represent activities that were greatly affected.
Outcome measures
| Measure |
Monarc
n=42 Participants
Placement of a transobturator monarc sling for stress urinary incontinence
Monarc: We will place a transobturator sling at the time of surgery for stress urinary incontinence
|
Mini-arc
n=41 Participants
Placement of a single incision mini-arc sling for stress urinary incontinence
Mini-arc: We will place a single incision sling at the time of surgery for stress urinary incontinence
|
|---|---|---|
|
Quality of Life Questionnaire IIQ-7
|
8.95 score on a scale
Standard Deviation 17.9
|
12.7 score on a scale
Standard Deviation 20.8
|
SECONDARY outcome
Timeframe: 1 yearResponse to validated questionnaire: International Consultation on Incontinence Questionnaire(ICIQ). The ICIQ is a screening tool for incontinence. The scoring scale is 0-21, minimum 0, maximum 21. a higher score indicates greater impairment from incontinence.
Outcome measures
| Measure |
Monarc
n=42 Participants
Placement of a transobturator monarc sling for stress urinary incontinence
Monarc: We will place a transobturator sling at the time of surgery for stress urinary incontinence
|
Mini-arc
n=41 Participants
Placement of a single incision mini-arc sling for stress urinary incontinence
Mini-arc: We will place a single incision sling at the time of surgery for stress urinary incontinence
|
|---|---|---|
|
Quality of Life Questionnaire ICIQ
|
3.1 scores on a scale
Standard Deviation 3.8
|
3.9 scores on a scale
Standard Deviation 4.3
|
Adverse Events
Monarc
Mini-arc
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Monarc
n=49 participants at risk
Placement of a transobturator monarc sling for stress urinary incontinence
Monarc: We will place a transobturator sling at the time of surgery for stress urinary incontinence
|
Mini-arc
n=49 participants at risk
Placement of a single incision mini-arc sling for stress urinary incontinence
Mini-arc: We will place a single incision sling at the time of surgery for stress urinary incontinence
|
|---|---|---|
|
Surgical and medical procedures
sling transectio
|
2.0%
1/49 • Number of events 1
|
2.0%
1/49 • Number of events 1
|
|
Surgical and medical procedures
mesh exposure
|
2.0%
1/49 • Number of events 1
|
6.1%
3/49 • Number of events 3
|
|
Surgical and medical procedures
dyspareunia
|
0.00%
0/49
|
2.0%
1/49
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place