Feasibility of BOTOX Injection on Improving Female Stress Urinary Incontinence

Sponsor

Weill Medical College of Cornell University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04984317

Collaborator

Allergan (Industry)

Enrollment

Location

Arm

17.5

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Stress Urinary Incontinence	Drug: onabotulinumtoxin A	Early Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Feasibility of Onabotulinumtoxin A Injection on Improving Female Stress Urinary Incontinence

Actual Study Start Date :

Feb 14, 2022

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Botox Injection One-time injection of 100U BOTOX (onabotulinumtoxin A) into the fundus of the bladder under direct visualization via cystoscopy.	Drug: onabotulinumtoxin A One-time injection of 100U BOTOX

Arm

Intervention/Treatment

Experimental: Botox Injection

One-time injection of 100U BOTOX (onabotulinumtoxin A) into the fundus of the bladder under direct visualization via cystoscopy.

Drug: onabotulinumtoxin A

One-time injection of 100U BOTOX

Outcome Measures

Primary Outcome Measures

Change in the amount of urinary leakage post-treatment compared to baseline. [Baseline, 1-month, 3-month, 6-month]
24-hour pad weight, in grams

Secondary Outcome Measures

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
Safety of 100U BOTOX injection as measured by the number of procedure-related adverse events. [1-month]
Adverse events may include organ perforation, bleeding, pelvic pain, infection, de novo dyspareunia, urinary retention, recurrent incontinence, other urinary problems and neuromuscular problems
Safety of 100U BOTOX injection as measured by the number of procedure-related adverse events. [3-month]
Adverse events may include organ perforation, bleeding, pelvic pain, infection, de novo dyspareunia, urinary retention, recurrent incontinence, other urinary problems and neuromuscular problems
Safety of 100U BOTOX injection as measured by the number of procedure-related adverse events. [6-month]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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.