Efficacy of Botulinum Toxin Type A in Patients With Bladder Pain Syndrome/Intersticial Cystitis and Hunners' Lesions

September 20, 2011 updated by: George Kasyan, Moscow State University of Medicine and Dentistry

Randomized Controlled Trial for Efficacy of Botulinum Toxin Type A in Treatment of Patients Suffering Bladder Pain Syndrome/Interstitial Cystitis With Hunners' Lesions

The etiology of bladder pain syndrome is unknown. Therefore the management is directed to pain relief, as bladder pain is believed to drive both voiding frequency and nocturia. Botulinum toxin A has been shown to decrease noxious input. Several studies showed efficacy of botox for treatment of painful bladder.

The aim of this study is to evaluate the efficacy of Botulinum toxin in patients who are suffering bladder pain syndrome with Hunner lesions during cystoscopy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 127206
        • Recruiting
        • Urology department of moscow state university of medicine and dentistry
        • Contact:

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • longer than 6 months of bladder pain syndrome/interstitial cystitis with Hunner Lesion(s) during cystoscopy

Exclusion Criteria:

  • Pregnancy
  • neurologic diseases
  • urinary tract infections
  • bladder outlet obstruction
  • previous pelvic radiotherapy

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: Botulinum toxin
Bladder intratrigonal injection of botulinum toxin (100 units) in 10 injection sites during cystoscopy under general anesthesia
Procedure: intratrigonal injection of botulinum toxin
Bladder intratrigonal injection of botulinum toxin during cystoscopy under general anesthesia
Sham Comparator: cystoscopy with hydrodistension
cystoscopy with hydrodistension under general anesthesia
Procedure: cystoscopy
cystoscopy under general anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in pain intensity
Time Frame: 1 week followed by 1, 3, and 6 months after BoNTA injection
Pain intensity is scored using a 10-point visual analog scale and change from baseline is observed
1 week followed by 1, 3, and 6 months after BoNTA injection
Change from baseline of intensity of bladder bother symptoms
Time Frame: within 1 week, at 3 months and 6 months
O'Leary-Sant score was used to assess symptoms and problems.
within 1 week, at 3 months and 6 months
Change from baseline of quality of life
Time Frame: within 1 week, at 3 months and 6 months
Quality of life (QoL) was evaluated using question 8 of the International Prostate Symptoms Score.
within 1 week, at 3 months and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postvoid residual urine volume
Time Frame: within 1 week, at 3months and 6 months after BoNTA injection
uroflowmetry with residual urine measurement
within 1 week, at 3months and 6 months after BoNTA injection
Upper urinary tract retention
Time Frame: 1 week, 3 months and 6 months after BoNTA injection
Kidney ultrasound investigation
1 week, 3 months and 6 months after BoNTA injection

Collaborators and Investigators

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

Sponsor

Moscow State University of Medicine and Dentistry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

June 1, 2011

Primary Completion (Anticipated)

December 1, 2011

Study Completion (Anticipated)

June 1, 2012

Study Registration Dates

First Submitted

September 18, 2011

First Submitted That Met QC Criteria

September 20, 2011

First Posted (Estimate)

September 21, 2011

Study Record Updates

Last Update Posted (Estimate)

September 21, 2011

Last Update Submitted That Met QC Criteria

September 20, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BPS/IC Bot1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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