Stress Urinary Incontinence
Conditions
Keywords
Urinary Incontinence, Incontinence
Brief summary
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
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.
Interventions
One-time injection of 100U BOTOX
Sponsors
Northwell Health
Allergan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the amount of urinary leakage post-treatment compared to baseline. | Baseline, 1-month, 3-month, 6-month | 1-hour pad weight, in grams |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of 100U BOTOX injection as measured by the number of procedure-related adverse events. | Time of Procedure | Adverse events may include organ perforation, bleeding, pelvic pain, infection, de novo dyspareunia, urinary retention, recurrent incontinence, other urinary problems and neuromuscular problems |
| Change in patient-reported symptoms of stress incontinence symptoms via PGI-I. | 1-month, 3-month, 6-month | 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. |
| Change in quality of life impacted by urinary incontinence via UDI-6. | Baseline, 1-month, 3-month, 6-month | 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. |
| Change in quality of life impacted by urinary incontinence via IIQ-7. | Baseline, 1-month, 3-month, 6-month | 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. |
| Assessment of patient satisfaction post-treatment via SSQ-8. | 1-month | The Surgical Satisfaction Questionnaire (SSQ-8) is a questionnaire about patient satisfaction after a surgery/procedure. Responses range from "Very unsatisfied" to "Very Satisfied". |
| Change in pain post-treatment compared to baseline via VAS. | Baseline, Time of Procedure, 1-month | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORBilal Chughtai, MD
Weill Medical College of Cornell University
Outcome results
None listed