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Minimizing Pain During Office Intradetrussor Botox Injection

NCT04270526 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2025-03-06

Study results available
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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

Interventions

DRUG

Bicarbonate protocol

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

DRUG

Standard protocol

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

Sponsors & Collaborators

  • Boston Urogynecology Associates

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-15
Primary Completion
2023-06-30
Completion
2023-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04270526 on ClinicalTrials.gov