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BOTOX® at the Time of Prolapse Surgery for OAB

Primary Purpose

Urinary Bladder, Overactive, Pelvic Organ Prolapse

Status

Unknown status

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

OnabotulinumtoxinA 100 UNT

Injectable saline

About this trial

This is an interventional treatment trial for Urinary Bladder, Overactive focused on measuring Botulinum Toxins, Type A, Mixed Urinary Incontinence, Urgency urinary incontinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Women scheduled for prolapse surgery
Bothersome OAB symptoms determined by a score of >20 on the OAB-q SF
Willingness to perform clean intermittent catheterization (CIC)
Ability to follow study instructions and complete required follow up

Exclusion Criteria:

Contraindications or allergy to Onabotulinumtoxin A
Intravesical Onabotulinumtoxin A within 3 months of the planned surgery date
Total body Onabotulinumtoxin A dose of ≥ 400 Units in the 3 months prior to the scheduled surgery date.
Inability or unwillingness to self-catheterize
Post-void residual ≥ 200mL
Neurogenic bladder or other neurological diseases that may cause voiding dysfunction
Concurrent use of other pharmacological treatment for the treatment of OAB symptoms at the time of prolapse repair surgery.
Females who are pregnant, think they may be pregnant at the start of the study, planning a pregnancy during the active treatment phase of the study, or who are unwilling or unable to use a reliable form of contraception during the active treatment phase of the study.
Inability to speak or read English

Sites / Locations

Walter Reed National Military Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intravesical OnabotulinumtoxinA

Placebo

Arm Description

The treatment group will receive 100 units of BOTOX® reconstituted in 10mL of injectable preservative-free normal saline at the time of cystoscopy. An injection cystoscopy needle will be set to 3mm and used to inject 0.5mL reconstituted OnabotulinumtoxinA at each injection site, approximately 1cm apart along the posterior bladder wall, for a total of 20 injection sites (4 rows of 5 injection sites). This will be the only treatment.

Subjects randomized to the placebo group will undergo the same procedure but will only receive 10mL of injectable preservative-free normal saline. This will be the only treatment.

Outcomes

Primary Outcome Measures

Change from baseline to postoperative weeks 6 to 12 in Overactive Bladder bother short form (OAB-q SF) questionnaire looking for a decrease of 10 points, which is the minimally important difference.

The OAB-q SF is a validated 6 item questionnaire that is scored and reported on a 0 to 100 point scale with increasing scores indicating more bother.

Secondary Outcome Measures

Change from baseline to postoperative weeks 6 to 12 in the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire short form (PISQ-12).

The PISQ-12 is a 12 item validated questionnaire that evaluates sexual function in women with urinary incontinence and/or pelvic organ prolapse. It is reported on a scale of 0-48, with a higher score indicating worse sexual function.

Change from baseline to postoperative weeks 6 to 12 in Patient Global Impression of Severity Scale (PGI-S).

The PGI-S is a 7 point Likert scale, ranging from 1 to 7, with an increasing score indicating greater severity.

Patient Global Impression of Improvement Scale (PGI-I) at 6 to 12 weeks postoperatively.

The PGI-I is a 7 point Likert scale, ranging from 1 to 7, with an increasing score indicating less improvement.

Urinary tract infection

Rate of urinary tract infections based on clinical suspicion and urine culture results

Urinary retention

Rate of urinary retention requiring catheterization, defined as a post-void residual of more than 400mL or 200-400mL with symptoms of incomplete bladder emptying.

Full Information

NCT ID

NCT04807920

First Posted

March 16, 2021

Last Updated

October 5, 2021

Sponsor

Walter Reed National Military Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT04807920

Brief Title

BOTOX® at the Time of Prolapse Surgery for OAB

Official Title

Intravesical OnabotulinumtoxinA Injection at the Time of Prolapse Surgery for the Treatment of Overactive Bladder Syndrome: a Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Unknown status

Study Start Date

September 23, 2021 (Actual)

Primary Completion Date

June 2023 (Anticipated)

Study Completion Date

June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Walter Reed National Military Medical Center

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 the study will be to assess the efficacy and safety of bladder BOTOX® for overactive bladder symptoms, such as urinary urgency and frequency, given at the time of prolapse surgery.

Detailed Description

After being informed about the study and the potential risks, women scheduled for prolapse surgery will be screened for bothersome overactive bladder symptoms. Those that qualify and choose to enroll will be randomized to receive either bladder BOTOX® or a placebo at the time of their surgery. Neither the patient nor the investigators will know if the patient receives BOTOX® or a placebo. Subjects will complete questionnaires and bladder diaries both before and after surgery to determine efficacy and patient satisfaction. Potential adverse events, such as urinary tract infections and urinary retention, will be monitored throughout the study.

6. Conditions and Keywords

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

Urinary Bladder, Overactive, Pelvic Organ Prolapse

Keywords

Botulinum Toxins, Type A, Mixed Urinary Incontinence, Urgency urinary incontinence

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

138 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intravesical OnabotulinumtoxinA

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Subjects randomized to the placebo group will undergo the same procedure but will only receive 10mL of injectable preservative-free normal saline. This will be the only treatment.

Intervention Type

Drug

Intervention Name(s)

OnabotulinumtoxinA 100 UNT

Intervention Description

Intravesical injection

Intervention Type

Other

Intervention Name(s)

Injectable saline

Other Intervention Name(s)

Placebo

Intervention Description

Intravesical injection

Primary Outcome Measure Information:

Title

Change from baseline to postoperative weeks 6 to 12 in Overactive Bladder bother short form (OAB-q SF) questionnaire looking for a decrease of 10 points, which is the minimally important difference.

Description

The OAB-q SF is a validated 6 item questionnaire that is scored and reported on a 0 to 100 point scale with increasing scores indicating more bother.

Time Frame

From baseline (time of enrollment) to 6-12 weeks postoperatively

Secondary Outcome Measure Information:

Title

Change from baseline to postoperative weeks 6 to 12 in the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire short form (PISQ-12).

Description

Time Frame

From baseline (time of enrollment) to 6-12 weeks postoperatively

Title

Change from baseline to postoperative weeks 6 to 12 in Patient Global Impression of Severity Scale (PGI-S).

Description

The PGI-S is a 7 point Likert scale, ranging from 1 to 7, with an increasing score indicating greater severity.

Time Frame

From baseline (time of enrollment) to 6-12 weeks postoperatively

Title

Patient Global Impression of Improvement Scale (PGI-I) at 6 to 12 weeks postoperatively.

Description

The PGI-I is a 7 point Likert scale, ranging from 1 to 7, with an increasing score indicating less improvement.

Time Frame

At 6-12 weeks postoperatively

Title

Urinary tract infection

Description

Rate of urinary tract infections based on clinical suspicion and urine culture results

Time Frame

From time of treatment to 12 weeks postoperative

Title

Urinary retention

Description

Rate of urinary retention requiring catheterization, defined as a post-void residual of more than 400mL or 200-400mL with symptoms of incomplete bladder emptying.

Time Frame

From 2 weeks postoperatively to 12 weeks postoperatively

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Women scheduled for prolapse surgery Bothersome OAB symptoms determined by a score of >20 on the OAB-q SF Willingness to perform clean intermittent catheterization (CIC) Ability to follow study instructions and complete required follow up Exclusion Criteria: Contraindications or allergy to Onabotulinumtoxin A Intravesical Onabotulinumtoxin A within 3 months of the planned surgery date Total body Onabotulinumtoxin A dose of ≥ 400 Units in the 3 months prior to the scheduled surgery date. Inability or unwillingness to self-catheterize Post-void residual ≥ 200mL Neurogenic bladder or other neurological diseases that may cause voiding dysfunction Concurrent use of other pharmacological treatment for the treatment of OAB symptoms at the time of prolapse repair surgery. Females who are pregnant, think they may be pregnant at the start of the study, planning a pregnancy during the active treatment phase of the study, or who are unwilling or unable to use a reliable form of contraception during the active treatment phase of the study. Inability to speak or read English

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Joy E Wheat, MD

Phone

201-710-5109

joy.e.wheat.mil@mail.mil

First Name & Middle Initial & Last Name or Official Title & Degree

Christine Vaccaro, DO

Phone

301-400-2468

christine.m.vaccaro.mil@mail.mil

Facility Information:

Facility Name

Walter Reed National Military Medical Center

City

Bethesda

State/Province

Maryland

ZIP/Postal Code

20889-560

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Walter Reed National Military M Center

12. IPD Sharing Statement

Plan to Share IPD

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BOTOX® at the Time of Prolapse Surgery for OAB

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