Procedural Discomfort Related to Number of Intradetrusor Botox Injections

NCT05652036 | Completed Phase 4 Results FDA Drug

• 1 other identifier: PRO00028592
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

Injection of intradetrusor OnabotulinumtoxinA (BTX-A) is a highly efficacious therapy with a reliable safety profile and demonstrable improvements in subjective and objective measures for overactive bladder (OAB) symptom control. This procedure can be performed in the office with an evidence-based standard dosing of 100 units for idiopathic OAB. This is a single-blinded, randomized control trial is to evaluate and optimize the technique for performing intradetrusor injections of BTX-A for idiopathic OAB. This trial proposes two different reconstitution and injection schema to study patient-centered outcomes related to procedural discomfort and symptom relief.

Conditions

Overactive Bladder

Keywords

Overactive bladder; Urinary urgency; Urgency incontinence; Botox

Outcome Measures

Primary Outcomes (1)

• Participant Discomfort Related to BTX-A Injection

  Participants will assess their discomfort using the Numeric Pain Scale (NPS), a validated 11-point scale (0-10) where higher scores indicate greater pain, before and immediately after the procedure. Procedural discomfort will be evaluated by comparing the change in NPS scores from pre- to post-procedure between study groups.

  Immediately post-procedure (up to 45min after intradetrusor BTX-A injections)

Secondary Outcomes (4)

• Procedural Efficacy - Overactive Bladder Questionnaire Short-Form (OAB-q SF)

  Prior to BTX-A injections and 30 days post-procedure

• Overall Treatment Satisfaction

  30 days post-procedure

• Impression of Clinical Improvement

  30 days post-procedure

• Procedural Outcomes

  30 days post-procedure

Study Arms (2)

5 mL Group

ACTIVE COMPARATOR

100 units BTX-A reconstituted in 5 mL normal saline, injected into the bladder in 5 separate injections of 1 mL. One injection will be at the trigone.

Biological: Intradetrusor Botox Injections

10 mL Group

ACTIVE COMPARATOR

100 units BTX-A reconstituted in 10 mL normal saline, injected into the bladder in 10 separate injections of 1 mL. One injection will be at the trigone

Biological: Intradetrusor Botox Injections

Interventions

Intradetrusor Botox Injections BIOLOGICAL

100 units of OnabotuliumtoxinA is injected into the detrusor muscle in 1 mL aliquots using a cystoscope.

10 mL Group; 5 mL Group

Eligibility Criteria

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

You may qualify if:

• Women scheduled to undergo 100 units intradetrusor BTX-A injections in the office for the diagnosis of idiopathic overactive bladder within the departments of Urology and Urogynecology
• years of age or older
• Able to give informed consent in English or Spanish
• Understand and are willing to undergo follow-up and complete all questionnaires as described in this protocol

You may not qualify if:

• Neurogenic bladder related to prior diagnosis of neurological conditions such as cerebral vascular accident within 6 months prior to treatment, Parkinson's Disease, Multiple Sclerosis, myelomeningocele, traumatic neurologic or spinal injury, or idiopathic diagnosis of neurogenic bladder.
• Symptomatic UTI at the time of procedure, defined as positive nitrites or high-volume leukocyte esterase on urine dip in addition to at least one of the following symptoms: dysuria, gross hematuria, suprapubic pain, frequency/urgency above baseline
• Diagnosis of a bladder pain syndrome or other chronic pain syndromes including fibromyalgia, chronic pelvic pain, pelvic floor dysfunction, levator myalgia
• Known bladder malignancy
• Previous history of bladder augmentation or reconstructive surgery not related to prolapse

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead

Study Sites (1)

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Miceli LM, Antosh DD, Nisar T, Stewart J, Rutledge EC, Khavari R. Pain Related to Intradetrusor BotulinumtoxinA: A Randomized Clinical Trial. Urogynecology (Phila). 2024 Mar 1;30(3):337-344. doi: 10.1097/SPV.0000000000001487.

  PMID: 38484251 DERIVED

MeSH Terms

Conditions

Urinary Bladder, Overactive

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

Limitations and Caveats

Possible small variations in injection technique were minimized through physician training. Patients were blinded to treatment, but non-naive patients may have biased pain scores based on prior experiences. Loss to follow-up at 30 days limits conclusions on secondary outcomes related to patient experience and procedural efficacy.

Results Point of Contact

• Title: Dr. Rose Khavari
• Organization: Houston Methodist Hospital Department of Urology

rkhavari@houstonmethodist.or

713-441-6455

Study Officials

• Rose Khavari, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: December 15, 2022
• Study Start: July 7, 2022
• Primary Completion: April 6, 2023
• Study Completion: May 15, 2023
• Last Updated: April 13, 2025
• Results First Posted: April 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)