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Feasibility of BOTOX Injection on Improving Female Stress Urinary Incontinence

Primary Purpose

Stress Urinary Incontinence

Status

Suspended

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

onabotulinumtoxin A

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring Urinary Incontinence, Incontinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

Weill Cornell Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Botox Injection

Arm Description

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

Outcomes

Primary Outcome Measures

Change in the amount of urinary leakage post-treatment compared to baseline.

1-hour pad weight, in grams

Secondary Outcome Measures

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

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

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

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

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.

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.

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.

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".

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.

Full Information

NCT ID

NCT04984317

First Posted

July 29, 2021

Last Updated

October 12, 2023

Sponsor

Weill Medical College of Cornell University

Collaborators

Allergan

1. Study Identification

Unique Protocol Identification Number

NCT04984317

Brief Title

Feasibility of BOTOX Injection on Improving Female Stress Urinary Incontinence

Official Title

Feasibility of Onabotulinumtoxin A Injection on Improving Female Stress Urinary Incontinence

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Suspended

Why Stopped

Principal Investigator changing locations.

Study Start Date

February 14, 2022 (Actual)

Primary Completion Date

August 2024 (Anticipated)

Study Completion Date

August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Weill Medical College of Cornell University

Collaborators

Allergan

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. 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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stress Urinary Incontinence

Keywords

Urinary Incontinence, Incontinence

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Botox Injection

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

onabotulinumtoxin A

Other Intervention Name(s)

BOTOX

Intervention Description

One-time injection of 100U BOTOX

Primary Outcome Measure Information:

Title

Change in the amount of urinary leakage post-treatment compared to baseline.

Description

1-hour pad weight, in grams

Time Frame

Baseline, 1-month, 3-month, 6-month

Secondary Outcome Measure Information:

Title

Safety of 100U BOTOX injection as measured by the number of procedure-related adverse events.

Description

Adverse events may include organ perforation, bleeding, pelvic pain, infection, de novo dyspareunia, urinary retention, recurrent incontinence, other urinary problems and neuromuscular problems

Time Frame

Time of Procedure

Title

Safety of 100U BOTOX injection as measured by the number of procedure-related adverse events.

Description

Adverse events may include organ perforation, bleeding, pelvic pain, infection, de novo dyspareunia, urinary retention, recurrent incontinence, other urinary problems and neuromuscular problems

Time Frame

1-month

Title

Safety of 100U BOTOX injection as measured by the number of procedure-related adverse events.

Description

Adverse events may include organ perforation, bleeding, pelvic pain, infection, de novo dyspareunia, urinary retention, recurrent incontinence, other urinary problems and neuromuscular problems

Time Frame

3-month

Title

Safety of 100U BOTOX injection as measured by the number of procedure-related adverse events.

Description

Adverse events may include organ perforation, bleeding, pelvic pain, infection, de novo dyspareunia, urinary retention, recurrent incontinence, other urinary problems and neuromuscular problems

Time Frame

6-month

Title

Change in patient-reported symptoms of stress incontinence symptoms via PGI-I.

Description

Time Frame

1-month, 3-month, 6-month

Title

Change in quality of life impacted by urinary incontinence via UDI-6.

Description

Time Frame

Baseline, 1-month, 3-month, 6-month

Title

Change in quality of life impacted by urinary incontinence via IIQ-7.

Description

Time Frame

Baseline, 1-month, 3-month, 6-month

Title

Assessment of patient satisfaction post-treatment via SSQ-8.

Description

The Surgical Satisfaction Questionnaire (SSQ-8) is a questionnaire about patient satisfaction after a surgery/procedure. Responses range from "Very unsatisfied" to "Very Satisfied".

Time Frame

1-month

Title

Change in pain post-treatment compared to baseline via VAS.

Description

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.

Time Frame

Baseline, Time of Procedure, 1-month

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bilal Chughtai, MD

Organizational Affiliation

Weill Medical College of Cornell University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Weill Cornell Medicine

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Feasibility of BOTOX Injection on Improving Female Stress Urinary Incontinence

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