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

NCT04124939 | Completed Phase 4 Results FDA Drug

• 1 other identifier: IRB00059454
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 2

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.

Conditions

Overactive Bladder

Keywords

Overactive Bladder; Botox/OnabotulinumtoxinA; Pain; OAB; Non-neurogenic Overactive bladder

Outcome Measures

Primary Outcomes (1)

• Numeric Pain Rating Scale (NPRS)

  The patients will rate their level of pain from 0 as no pain to 10 as a severe pain immediately following the completion of bladder injections by selecting a whole number from 0 to 10 that represents their level of pain during the procedure.

  Post Procedure Day 1

Secondary Outcomes (9)

• Difference in Mean Urge Incontinence Episodes

  Week 12 after procedure

• Over Active Bladder (OAB) Questionnaire Short Form Scores - Symptoms

  Baseline

• Over Active Bladder (OAB) Questionnaire Short Form Scores - Symptoms

  2 weeks post procedure

• Over Active Bladder (OAB) Questionnaire Short Form Scores - Symptoms

  12 weeks post procedure

• Over Active Bladder (OAB) Questionnaire Short Form Scores - Health Related Quality of Life

  Baseline

Study Arms (2)

10 Botox Injections

ACTIVE COMPARATOR

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.

Drug: OnabotulinumtoxinA 100 Units

20 Botox Injections

ACTIVE COMPARATOR

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.

Drug: OnabotulinumtoxinA 100 Units

Interventions

OnabotulinumtoxinA 100 Units 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.

Also known as: BOTOX

10 Botox Injections; 20 Botox Injections

Eligibility Criteria

• Age: 18 Years - 90 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (2)

Urology clinic locations at Wake Forest Baptist Medical Center

Greensboro, North Carolina, 27455, United States

Location

Urology clinic locations at Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive; Pain

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Results Point of Contact

• Title: Sachin N. Vyas, Research Manager
• Organization: Urology Department, Wake Forest University

svyas@wakehealth.edu

336-713-4098

Study Officials

• Catherine Matthews, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2019
• First Posted: October 14, 2019
• Study Start: November 10, 2019
• Primary Completion: November 9, 2022
• Study Completion: February 23, 2023
• Last Updated: April 17, 2024
• Results First Posted: October 13, 2023

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)