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Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms

Primary Purpose

Urinary Incontinence, Overactive Bladder Syndrome, Overactive Bladder

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

OnabotulinumtoxinA

About this trial

This is an interventional treatment trial for Urinary Incontinence

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: Males 18 -89 undergoing HoLEP Component of OAB symptoms including frequency, nocturia, urgency, and/or urge related incontinence Willing to sign the Informed Consent Form Able to read, understand, and complete patient questionnaires. Exclusion Criteria: Allergy or hypersensitivity to OnabotulinumtoxinA injections Patients having a concurrent ureteroscopy +/- laser lithotripsy, percutaneous nephrolithotomy, or non-urologic surgery at the time of their HoLEP Anticipated need for perineal urethrostomy at the time of HoLEP Prior pelvic radiation or patients with a history of bladder cancer with or without BCG therapy Patients who lack decisional capacity Active urinary tract infection

Sites / Locations

Northwestern MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intra-detrusor OnabotulinumtoxinA Injection

No intra-detrusor OnabotulinumtoxinA Injection

Arm Description

Injection of intra-detrusor OnabotulinumtoxinA into the bladder will be performed.

Injection of intra-detrusor OnabotulinumtoxinA into the bladder will not be performed.

Outcomes

Primary Outcome Measures

Improve Overactive Bladder Symptoms (OAB) utilizing botox injections into the bladder.

Examine the safety and effect of intra-detrusor botulinum toxin injections at the time of helium laser enucleation of the prostate (HoLEP) in men with overactive bladder symptoms with and without urge incontinence.

Secondary Outcome Measures

Difference in safety/ adverse effects

Identifying changes in post-op urinary retention, gross hematuria, UTI, ED visits and any additional complications.

Difference in patient REDCap surveys (gross hematuria dysuria, incontinence)

Identifying symptom resolution at different time points (1 month, 3 months, 6 months)

Difference in efficacy endpoints (3-month clinic/telephone follow-up)

Identifying efficacy endpoints as they relate to the use of anti-cholinergics, incontinence survey, post void residuals, continence pads requirements if any.

Full Information

NCT ID

NCT05878951

First Posted

May 4, 2023

Last Updated

October 10, 2023

Sponsor

Northwestern University

Collaborators

University of Calgary, Ohio State University, University of Alberta

1. Study Identification

Unique Protocol Identification Number

NCT05878951

Brief Title

Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms

Official Title

A Multicenter Randomized Controlled Trial Examining the Effects of Intra-detrusor Botulinum Toxin at Time of Holmium Laser Enucleation of the Prostate (HoLEP) in Men With Overactive Bladder (OAB) Symptoms

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 13, 2023 (Actual)

Primary Completion Date

June 1, 2024 (Anticipated)

Study Completion Date

August 24, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Northwestern University

Collaborators

University of Calgary, Ohio State University, University of Alberta

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 objective of our multi-center randomized single-blind study is to examine the safety and effect of intra-detrusor OnabotulinumtoxinA injections at the time of holium laser enucleation of the prostate (HoLEP) in men with overactive bladder symptoms with and without urge incontinence.

Detailed Description

Patients with significant preoperative urgency and/or urge urinary incontinence (UUI) along with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) may require post-HoLEP anticholinergic, B-3 agonist, or intravesical OnabotulinumtoxinA administration. This injection is a guideline recommended for treatment in patients with severe irritative LUTS (urgency, UUI) and overactive bladder.

6. Conditions and Keywords

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

Urinary Incontinence, Overactive Bladder Syndrome, Overactive Bladder, Urologic Diseases

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intra-detrusor OnabotulinumtoxinA Injection

Arm Type

Experimental

Arm Description

Injection of intra-detrusor OnabotulinumtoxinA into the bladder will be performed.

Arm Title

No intra-detrusor OnabotulinumtoxinA Injection

Arm Type

No Intervention

Arm Description

Injection of intra-detrusor OnabotulinumtoxinA into the bladder will not be performed.

Intervention Type

Drug

Intervention Name(s)

OnabotulinumtoxinA

Other Intervention Name(s)

Botox

Intervention Description

Intra-detrusor OnabotulinumtoxinA is commonly known as botox

Primary Outcome Measure Information:

Title

Improve Overactive Bladder Symptoms (OAB) utilizing botox injections into the bladder.

Description

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Difference in safety/ adverse effects

Description

Identifying changes in post-op urinary retention, gross hematuria, UTI, ED visits and any additional complications.

Time Frame

90 days

Title

Difference in patient REDCap surveys (gross hematuria dysuria, incontinence)

Description

Identifying symptom resolution at different time points (1 month, 3 months, 6 months)

Time Frame

6 months

Title

Difference in efficacy endpoints (3-month clinic/telephone follow-up)

Description

Identifying efficacy endpoints as they relate to the use of anti-cholinergics, incontinence survey, post void residuals, continence pads requirements if any.

Time Frame

3 months

10. Eligibility

Sex

Male

Gender Based

Yes

Gender Eligibility Description

Men experiencing overactive bladder symptoms

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

89 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

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

Alyssa McDonald

Phone

312-695-8146

Alyssa.McDonald@northwestern.edu

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

Allaa Fadl-Alla

Phone

312-695-8146

Allaa.Fadlalla@northwestern.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Amy Krambeck, MD

Organizational Affiliation

Northwestern University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Northwestern Medicine

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alyssa McDonald

12. IPD Sharing Statement

Learn more about this trial

Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms

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