Mixed Urinary Incontinence, Stress Urinary Incontinence, Urgency Incontinence
Conditions
Brief summary
This double-blind randomized controlled trial seeks to find a better treatment for women with mixed urinary incontinence (both stress and urgency incontinence). The primary aim is to determine whether midurethral sling surgery combined with injections of onabotulinumtoxinA (Botox®) into the detrusor muscle of the bladder improves symptoms of mixed urinary incontinence better than sling surgery alone.
Interventions
DRUGOnabotulinumtoxinA (Botox ®) Injections
OnabotulinumtoxinA (Botox ®) is a neurotoxin, which inhibits acetylcholine release and temporarily relaxes the bladder muscle to inhibit urgency incontinence.
Saline will be injected into the bladder so that investigators are masked to subject randomization.
Sponsors
Friends of Prentice
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Undergoing mid-urethral sling surgery * Have symptoms of both stress and urgency urinary incontinence * Able to consent, fill out study documents, and complete all study procedures and follow-up visits * At least 18 years of age * English speaking * Be able and willing to learn clean intermittent self catheterization technique
Exclusion criteria
* History of recurrent UTI (defined as three culture proven UTIs within last 12 months) * Systemic neuromuscular disease known to affect the lower urinary tract * Undergoing concomitant prolapse surgery * Previous incontinence surgery * Treatment with anticholinergic medication in the last 2 months * Previous bladder injection with onabotulinumtoxinA * Prisoner Status * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Self-reported Mixed Urinary Incontinence Symptoms | 3 months after surgery | Mixed urinary incontinence symptoms will be assessed by the Patient Global Assessment of Improvement (PGI-I) survey, a patient oriented outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incontinence Episode Frequency | 3 months after surgery | Incontinence episode frequency will be assessed by a self-report 3-day urinary diary completed by the subject |
| Urinary Incontinence Symptoms and Quality of Life | 3 months after surgery | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Group/Saline Injections The placebo arm received intradetrusor saline injections at the time of their sling. | 37 |
| Onabotulinum Toxin A 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. | 41 |
| Total | 78 |
Baseline characteristics
| Characteristic | Placebo Group/Saline Injections | Total | Onabotulinum Toxin A |
|---|---|---|---|
| Age, Continuous | 50.5 years STANDARD_DEVIATION 10 | 51 years STANDARD_DEVIATION 10 | 51.1 years STANDARD_DEVIATION 10 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 19 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants | 52 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants | 7 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 9 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 7 Participants | 3 Participants |
| Race (NIH/OMB) White | 28 Participants | 60 Participants | 32 Participants |
| Region of Enrollment United States | 37 participants | 78 participants | 41 participants |
| Sex: Female, Male Female | 37 Participants | 78 Participants | 41 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| UDI-6 | 58.3 units on a scale | 62.50 units on a scale | 66.7 units on a scale |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 37 | 0 / 41 |
| other Total, other adverse events | 6 / 37 | 22 / 41 |
| serious Total, serious adverse events | 1 / 37 | 0 / 41 |
Outcome results
Primary
Number of Participants With Self-reported Mixed Urinary Incontinence Symptoms
Mixed urinary incontinence symptoms will be assessed by the Patient Global Assessment of Improvement (PGI-I) survey, a patient oriented outcome
Time frame: 3 months after surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo Group | Number of Participants With Self-reported Mixed Urinary Incontinence Symptoms | 31 Participants |
| Onabotulinim Toxin A Group | Number of Participants With Self-reported Mixed Urinary Incontinence Symptoms | 34 Participants |
Secondary
Incontinence Episode Frequency
Incontinence episode frequency will be assessed by a self-report 3-day urinary diary completed by the subject
Time frame: 3 months after surgery
Population: Incontinence Episode Frequency on 3 day Diary
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo Group | Incontinence Episode Frequency | 0 episodes |
| Onabotulinim Toxin A Group | Incontinence Episode Frequency | 0 episodes |
Secondary
Urinary Incontinence Symptoms and Quality of Life
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.
Time frame: 3 months after surgery
Population: IIQ-7: Incontinence QOL
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo Group | Urinary Incontinence Symptoms and Quality of Life | 4.8 units on a scale |
| Onabotulinim Toxin A Group | Urinary Incontinence Symptoms and Quality of Life | 0 units on a scale |