Minimizing Pain During Office Intradetrussor Botox Injection

NCT04270526 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 037-2019
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a prospective double-blinded randomized controlled trial comparing two pre-treatment protocols for patients undergoing intradetrussor botox injections to determine if a buffered lidocaine solution offers superior pain control.

Conditions

Overactive Bladder; Overactive Detrusor; Overactive Bladder Syndrome; Overactivity; Behavior; Urge Incontinence

Outcome Measures

Primary Outcomes (1)

• Pain: VAS

  Pain on visual analog scale from 0-100 with higher scores worse

  Immediately after the procedure

Secondary Outcomes (2)

• Satisfaction: Likert Scale

  Immediately after the procedure

• Willingness to Undergo Repeat Procedure

  Immediately after the procedure

Study Arms (2)

Active treatment

ACTIVE COMPARATOR

50 mL 1% lidocaine + 45ml of 0.9% normal saline + 5 mL 8.4% sodium bicarbonate

Drug: Bicarbonate protocol

Placebo treatment

PLACEBO COMPARATOR

50 mL 1% lidocaine + 50ml of 0.9% normal saline

Drug: Standard protocol

Interventions

Bicarbonate protocol DRUG

Intradetrussor treatment with 50 mL 1% lidocaine + 45ml of 0.9% normal saline + 5 mL 8.4% sodium bicarbonate

Active treatment

Standard protocol DRUG

Intradetrussor treatment with 50 mL 1% lidocaine + 50ml of 0.9% normal saline

Placebo treatment

Eligibility Criteria

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

You may qualify if:

• Female patient
• Primary diagnosis of overactive bladder
• Failed first and second line therapy for overactive bladder
• Planning to undergo bladder botox injections

You may not qualify if:

• Neurogenic bladder
• Urinary retention

Sponsors & Collaborators

• Boston Urogynecology Associates: lead

Study Sites (1)

Boston Urogynecology Associates

Cambridge, Massachusetts, 02138, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive; Spasm; Urinary Incontinence, Urge

Interventions

AIEOP acute lymphoblastic leukemia protocol

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; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Urinary Incontinence; Urination Disorders

Results Point of Contact

• Title: William Winkelman
• Organization: Mount Auburn Hospital

william.winkelman@mah.harvard.edu

617-354-5452

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Instructor

Model Details: All subjects will be randomized 1:1 at the first intervention visit to one of the two protocols using a random block design

Study Record Dates

• First Submitted: February 12, 2020
• First Posted: February 17, 2020
• Study Start: August 15, 2020
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: March 6, 2025
• Results First Posted: March 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)