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Optimal Injection Interval for Intra-Detrusor Botulinum Toxin

NCT06483217 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-07-17

No results posted yet for this study

Summary

The goal of this clinical trial is to see if patients deciding their own follow up times can increase the effectiveness of botulinum toxin (BTX or "Botox") injection for overactive bladder (OAB). The main questions it aims to answer are:

* Does the time between repeat injections differ from the 6-month standard when it is based on patient symptoms alone?
* Does symptom control or patient satisfaction change when patients control their own follow up times?

Participants will undergo standard botulinum toxin injection into the bladder for OAB treatment and will then be randomly assigned to follow up either at a standard 6-month interval or whenever they feel their symptoms return.

Conditions

Interventions

BEHAVIORAL

Patient-directed follow up

Patients will be instructed to follow up for repeat injection based on bladder symptomatology at their own self-determined time interval.

Sponsors & Collaborators

  • Louisiana State University Health Sciences Center in New Orleans

    lead OTHER

Principal Investigators

  • Lisa Peacock, MD · Louisiana State University Health Science Center - New Orleans

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-31
Primary Completion
2025-07-31
Completion
2025-10-31

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 NCT06483217 on ClinicalTrials.gov