Feasibility of BOTOX Injection on Improving Female Stress Urinary Incontinence

Stress Urinary Incontinence Clinical Trial

Official title:

Feasibility of Onabotulinumtoxin A Injection on Improving Female Stress Urinary Incontinence

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04984317
• Other study ID #: 20-04021756
• Status: Suspended
• Phase: Early Phase 1
• Start date: February 14, 2022
• Est. completion date: August 2025

Study information

• Verified date: October 2023
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 20
• Est. completion date: August 2025
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Drug:
• onabotulinumtoxin A
One-time injection of 100U BOTOX

Locations

Country	Name	City	State
United States	Weill Cornell Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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