Different Injection Site Maps & Intravesical Botulinum Toxin

August 13, 2024 updated by: Başakşehir Çam & Sakura City Hospital

The Effect of Different Injection Site Maps on Intravesical Botulinum Toxin of Bladder

Botulinum toxin injection into the bladder is used in current practice in urological diseases such as overactive bladder or interstitial cystitis. As far as is known, botulinum toxin injection sites have not been clearly defined. In this study, investigators are planning to compare botulinum toxin effectiveness with different injection site maps.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Older than 18 years
  • Interstitial cystitis patients
  • Overactive bladder

Exclusion Criteria:

  • younger than 18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: MAP 1 (Posterior wall only)
Type 1 map injection will be used to bladder in one session. In this arm, Botulinum toxin type A injection will be apply to non-trigonal only posterior wall of bladder. The application will be done with cystoscopy and, 20 different point will be aimed. Totally 100 IU Botulinum toxin type A will be applied.
Other: Intravesical Botulinum Toxin
Botulinum Toxin injections will be made into the bladder.
Active Comparator: MAP 2 (Posterior wall + bilateral side walls)
Type 2 map injection will be used to bladder in one session. In this arm, Botulinum toxin type A injection will be apply to non-trigonal posterior wall + bilateral side walls of bladder. The application will be done with cystoscopy and, 20 different point will be aimed. Totally 100 IU Botulinum toxin type A will be applied.
Other: Intravesical Botulinum Toxin
Botulinum Toxin injections will be made into the bladder.
Active Comparator: MAP 3 (Non-trigonal all walls)
Type 3 map injection will be used to bladder in one session In this arm, Botulinum toxin type A injection will be apply to non-trigonal all walls of bladder. The application will be done with cystoscopy and, 20 different point will be aimed. Totally 100 IU Botulinum toxin type A will be applied.
Other: Intravesical Botulinum Toxin
Botulinum Toxin injections will be made into the bladder.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overactive bladder-V8 questionnaire will be used for efficacy of treatment.
Time Frame: Estimated 1 month for every patient after treatment.
The questionnaire contains 8 questions and every question may be scored between 0 and 5. Additionally, male gender get 2 points more. Therefore, a patient may be get between 0 and 42 points. More score means worse complaint.
Estimated 1 month for every patient after treatment.
Urodynamics test will be assessed for efficacy of treatment.
Time Frame: Estimated 1 month for every patient after treatment.
Possible bladder contractions and residual volume will be measured in urodynamic testing to demonstrate effectiveness after treatment. The lack of pathological bladder contractions and normal residual urine mean better for patient and, show improving.
Estimated 1 month for every patient after treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Başakşehir Çam & Sakura City Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2024

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

November 28, 2023

First Submitted That Met QC Criteria

December 25, 2023

First Posted (Actual)

December 29, 2023

Study Record Updates

Last Update Posted (Actual)

August 15, 2024

Last Update Submitted That Met QC Criteria

August 13, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KAEK/08.11.2023.530

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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