Is 10 Injections of Bladder Botox Less Painful Than 20 Injections?

NCT ID: NCT04124939

Last Updated: 2024-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-10
• Study Completion Date: 2023-02-23

Brief Summary

The purpose of this research study is to help determine if 10 injections of Botox ® 100 units is less painful than 20 injections of Botox ® 100 units based on effectiveness in reducing urge incontinence episodes. Study will also be assessed for the pain of procedure and adverse outcomes of 20 injections versus 10 injections.

Detailed Description

This study is a randomized clinical trial to assess whether or not 10 injections of 100 units of intradetrusor Botox® toxin is perceived as less painful compared to 20 injections of 100 units of intradetrusor Botox® toxin for the treatment of refractory overactive bladder.

Conditions

Overactive Bladder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

10 Botox Injections

100 units of Botox® (onabotulinumtoxinA) will be combined with 10 cc of sterile saline for the purpose of 10 injections. The bladder will be instilled with 2% lidocaine solution through a catheter for at least 5 minutes prior to the procedure. Cystoscopy with either a rigid or flexible cystoscope (per surgeon preference) will be performed using sterile technique. The Botox® will be injected in a grid like pattern avoiding the trigone.

Group Type: ACTIVE_COMPARATOR

OnabotulinumtoxinA 100 Units

Intervention Type: DRUG

BOTOX for injection is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for:

• Treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication.

20 Botox Injections

100 units of Botox® (onabotulinumtoxinA) will be combined with 20 cc of sterile saline for the purpose of 20 injections. The bladder will be instilled with 2% lidocaine solution through a catheter for at least 5 minutes prior to the procedure. Cystoscopy with either a rigid or flexible cystoscope (per surgeon preference) will be performed using sterile technique. The Botox® will be injected in a grid like pattern avoiding the trigone.

Group Type: ACTIVE_COMPARATOR

OnabotulinumtoxinA 100 Units

Intervention Type: DRUG

BOTOX for injection is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for:

• Treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication.

Interventions

OnabotulinumtoxinA 100 Units

BOTOX for injection is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for:

• Treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication.

Intervention Type: DRUG

Other Intervention Names

BOTOX

Eligibility Criteria

Inclusion Criteria

• Female gender
• At least 18 years of age
• Have already decided to undergo intradetrusor Botox® injections for treatment of refractory overactive bladder.
• Able and willing to learn clean intermittent catheterization (or care provider is willing and able to perform intermittent catheterization).
• Understands and is willing to undergo follow up and complete questionnaires as described in this protocol
• Able to give informed consent

Exclusion Criteria

• Male gender
• Neurological conditions (Examples: Cerebral vascular accident within 6 months prior to treatment, Parkinson's disease, Multiple Sclerosis, and Spina Bifida).
• Acute urinary tract infection
• Treatment with Botox® toxin for other conditions
• Allergy to Botox® toxin
• Hematuria that has not been worked up
• Known bladder malignancy
• Previous history of bladder augmentation
• Currently pregnant (with no plans to become pregnant within 6 months of enrollment) or breastfeeding
• Currently taking aminoglycoside antibiotics
• Post-void residual (PVR) >150 cc (measured by bladder scan or by catheterization) prior to enrollment
• History of chronic pain or pain syndromes

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Catherine Matthews, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Urology clinic locations at Wake Forest Baptist Medical Center

Greensboro, North Carolina, United States

Urology clinic locations at Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

IRB00059454

Identifier Type: -

Identifier Source: org_study_id