Feasibility of BOTOX Injection on Improving Female Stress Urinary Incontinence

Study Overview
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Brief Summary
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The purpose of this study is to assess the effect of onabotulinumtoxin A (BOTOX) injection into the detrusor muscle on increasing bladder compliance to reduce urinary leakage in women suffering from stress urinary incontinence (SUI).

Detailed Description
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The study involves a single-time injection of 100 units of onabotulinumtoxin A into the detrusor muscle of the bladder. Cystoscopy, which is the insertion of a scope with a small camera inside a tube into the participant's urethra. Then the doctor fills the participant's bladder with water or saline and sees detailed images of the injection site in the bladder while administrating the injection.

Official Title
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Feasibility of Onabotulinumtoxin A Injection on Improving Female Stress Urinary Incontinence

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Drug: onabotulinumtoxin A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be female sex and at least 18 years of age. Must be willing and able to complete all procedures and follow-up visits indicated in the protocol. Must have confirmed stress urinary incontinence (SUI) through urodynamic studies. Must have failed two non-invasive incontinence therapies (such as behavior modification, Kegel exercises, etc) for > 3 months. Exclusion Criteria: Currently suffering from active urogenital infection. Has incontinence due to neurogenic causes (such as multiple sclerosis, cerebrovascular accident, spinal cord/brain injury, Parkinson Disease, detrusor-external sphincter dyssynergia, or similar conditions). Having concomitant pelvic floor or cystoscopic procedure. Has had prior surgical SUI treatment. Has had prior radiation therapy or brachy therapy. Has an atonic bladder or post-void residual (PVR) above 100cc on two or more occasions. Is pregnant or planning to become pregnant during the study duration. Has a contraindication to therapeutic BOTOX injections or cystoscopic procedures. Is enrolled in a concurrent clinical trial of any treatment (drug or device) that could affect urinary continence or bladder function without the sponsor's approval.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Botox Injection<br>One-time injection of 100U BOTOX (onabotulinumtoxin A) into the fundus of the bladder under direct visualization via cystoscopy. | Drug: onabotulinumtoxin A<br>* One-time injection of 100U BOTOX<br>* Other names: BOTOX;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the amount of urinary leakage post-treatment compared to baseline. | 1-hour pad weight, in grams | Baseline, 1-month, 3-month, 6-month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of 100U BOTOX injection as measured by the number of procedure-related adverse events. | Adverse events may include organ perforation, bleeding, pelvic pain, infection, de novo dyspareunia, urinary retention, recurrent incontinence, other urinary problems and neuromuscular problems | Time of Procedure | 
| Safety of 100U BOTOX injection as measured by the number of procedure-related adverse events. | Adverse events may include organ perforation, bleeding, pelvic pain, infection, de novo dyspareunia, urinary retention, recurrent incontinence, other urinary problems and neuromuscular problems | 1-month | 
| Safety of 100U BOTOX injection as measured by the number of procedure-related adverse events. | Adverse events may include organ perforation, bleeding, pelvic pain, infection, de novo dyspareunia, urinary retention, recurrent incontinence, other urinary problems and neuromuscular problems | 3-month | 
| Safety of 100U BOTOX injection as measured by the number of procedure-related adverse events. | Adverse events may include organ perforation, bleeding, pelvic pain, infection, de novo dyspareunia, urinary retention, recurrent incontinence, other urinary problems and neuromuscular problems | 6-month | 
| Change in patient-reported symptoms of stress incontinence symptoms via PGI-I. | The Patient Global Impression of Improvement (PGI-I) scale is a scale that measures improvement in symptoms and ranges from 1-7, with 1 indicating very much improvement and higher scores indicating less improvement. | 1-month, 3-month, 6-month | 
| Change in quality of life impacted by urinary incontinence via UDI-6. | The Urinary Distress Inventory (UDI-6) is an inventory that assess symptoms and urinary incontinence and its severity on a scale of 0 to 3, with higher scores indicating greater symptom severity. IIQ-7 is a 30-item self-report questionnaire on the impact of urinary incontinence on activities roles and emotional states. Assigned values of the questionnaire are 0 for not at all, 1 for slightly, 2 for moderately, and 3 for greatly. | Baseline, 1-month, 3-month, 6-month | 
| Change in quality of life impacted by urinary incontinence via IIQ-7. | The Incontinence Impact Questionnaire (IIQ-7) is a 30-item self-report questionnaire on the impact of urinary incontinence on activities roles and emotional states. Assigned values of the questionnaire are 0 for not at all, 1 for slightly, 2 for moderately, and 3 for greatly. | Baseline, 1-month, 3-month, 6-month | 
| Assessment of patient satisfaction post-treatment via SSQ-8. | The Surgical Satisfaction Questionnaire (SSQ-8) is a questionnaire about patient satisfaction after a surgery/procedure. Responses range from Very unsatisfied to Very Satisfied. | 1-month | 
| Change in pain post-treatment compared to baseline via VAS. | Scores are measured on a 100mm Visual Analog Scale (VAS). The VAS ranges from 0 to 100 with 0 indicating no pain and higher scores indicating greater pain. | Baseline, Time of Procedure, 1-month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urinary Incontinence, Incontinence