Trial Outcomes & Findings for The SLIM Study: Sling and Botox® Injection for Mixed Urinary Incontinence (NCT NCT02678377)
NCT ID: NCT02678377
Last Updated: 2023-03-14
Results Overview
Mixed urinary incontinence symptoms will be assessed by the Patient Global Assessment of Improvement (PGI-I) survey, a patient oriented outcome
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
100 participants
Primary outcome timeframe
3 months after surgery
Results posted on
2023-03-14
Participant Flow
Note: 100 participants were consented and is the enrollment number, but 12 participants cancelled their surgeries after having signed the consent form. Thus, 88 participants were randomized and are included in the analysis.
Participant milestones
| Measure |
OnabotulinumtoxinA Injections
100 units of OnabotulinumtoxinA (Botox®) injected into the detrusor (large muscle of the bladder) at the time of sling surgery.
OnabotulinumtoxinA (Botox ®) Injections: OnabotulinumtoxinA (Botox ®) is a neurotoxin, which inhibits acetylcholine release and temporarily relaxes the bladder muscle to inhibit urgency incontinence.
|
Saline Injections
100 units of saline injected into the detrusor (large muscle of the bladder) at the time of sling surgery.
Saline Injections: Saline will be injected into the bladder so that investigators are masked to subject randomization.
|
|---|---|---|
|
Overall Study
COMPLETED
|
41
|
37
|
|
Overall Study
STARTED
|
45
|
43
|
|
Overall Study
NOT COMPLETED
|
4
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The SLIM Study: Sling and Botox® Injection for Mixed Urinary Incontinence
Baseline characteristics by cohort
| Measure |
Placebo Group/Saline Injections
n=37 Participants
The placebo arm received intradetrusor saline injections at the time of their sling.
|
Onabotulinum Toxin A
n=41 Participants
The onabotulinum toxin A group received intradetrusor injections of 100 U onabotulinum toxin A and the placebo group received intradetrusor injections of saline at the time of midurethral sling.
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.5 years
STANDARD_DEVIATION 10 • n=5 Participants
|
51.1 years
STANDARD_DEVIATION 10 • n=7 Participants
|
51 years
STANDARD_DEVIATION 10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
37 participants
n=5 Participants
|
41 participants
n=7 Participants
|
78 participants
n=5 Participants
|
|
UDI-6
|
58.3 units on a scale
n=5 Participants
|
66.7 units on a scale
n=7 Participants
|
62.50 units on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 months after surgeryMixed urinary incontinence symptoms will be assessed by the Patient Global Assessment of Improvement (PGI-I) survey, a patient oriented outcome
Outcome measures
| Measure |
Placebo Group
n=37 Participants
The placebo arm received intradetrusor saline injections at the time of their sling.
|
Onabotulinim Toxin A Group
n=41 Participants
Received 100 U intradetrusor onabotulinum toxin A.
|
|---|---|---|
|
Number of Participants With Self-reported Mixed Urinary Incontinence Symptoms
|
31 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: 3 months after surgeryPopulation: Incontinence Episode Frequency on 3 day Diary
Incontinence episode frequency will be assessed by a self-report 3-day urinary diary completed by the subject
Outcome measures
| Measure |
Placebo Group
n=37 Participants
The placebo arm received intradetrusor saline injections at the time of their sling.
|
Onabotulinim Toxin A Group
n=41 Participants
Received 100 U intradetrusor onabotulinum toxin A.
|
|---|---|---|
|
Incontinence Episode Frequency
|
0 episodes
Interval 0.0 to 2.0
|
0 episodes
Interval 0.0 to 2.0
|
SECONDARY outcome
Timeframe: 3 months after surgeryPopulation: IIQ-7: Incontinence QOL
Urinary incontinence symptoms and quality of life will be assessed by a satisfaction survey completed by the subject. The scale is 0-100. and higher scores indicate worse outcomes.
Outcome measures
| Measure |
Placebo Group
n=37 Participants
The placebo arm received intradetrusor saline injections at the time of their sling.
|
Onabotulinim Toxin A Group
n=41 Participants
Received 100 U intradetrusor onabotulinum toxin A.
|
|---|---|---|
|
Urinary Incontinence Symptoms and Quality of Life
|
4.8 units on a scale
Interval 0.0 to 23.8
|
0 units on a scale
Interval 0.0 to 9.5
|
Adverse Events
Placebo Group/Saline Injections
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Onabotulinum Toxin A Group
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo Group/Saline Injections
n=37 participants at risk
Placebo Group/Saline Injections
|
Onabotulinum Toxin A Group
n=41 participants at risk
100 U onabotulinum toxin A group
|
|---|---|---|
|
Renal and urinary disorders
Reoperation
|
2.7%
1/37 • Number of events 1 • 3-months
|
0.00%
0/41 • 3-months
|
Other adverse events
| Measure |
Placebo Group/Saline Injections
n=37 participants at risk
Placebo Group/Saline Injections
|
Onabotulinum Toxin A Group
n=41 participants at risk
100 U onabotulinum toxin A group
|
|---|---|---|
|
Renal and urinary disorders
Urinary Retention within 2 Weeks Surgery
|
5.4%
2/37 • Number of events 2 • 3-months
|
12.2%
5/41 • Number of events 5 • 3-months
|
|
Renal and urinary disorders
Urinary Retention between 2 Weeks and 3 Months
|
2.7%
1/37 • Number of events 1 • 3-months
|
12.2%
5/41 • Number of events 5 • 3-months
|
|
Renal and urinary disorders
Mesh Exposure
|
2.7%
1/37 • Number of events 1 • 3-months
|
7.3%
3/41 • Number of events 3 • 3-months
|
|
Renal and urinary disorders
UTI
|
5.4%
2/37 • Number of events 2 • 3-months
|
22.0%
9/41 • Number of events 9 • 3-months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place