Bladder Thermal Distention for Patients With Interstitial Cystitis / Painful Bladder Syndrome (IC)

April 23, 2013 updated by: Assaf-Harofeh Medical Center
Patients with Interstitial Cystitis / PBS will be treated with bladder thermal distention (BTD).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In this study we will evaluate the efficacy of bladder thermal distention (BTD) in patients with IC/PBS.

Patients with previous failed conventional treatment (intravesical DMSO) will be recruited.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

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

  • Israel
      • Zerifin, Israel, 70300
        • Recruiting
        • Assaf Harofe Medical Center
        • Principal Investigator:
          • Kobi Stav, MD
        • 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:

-All patients with interstitial cystitis / painful bladder syndrome (IC/PBS) who had previous intravesical treatment with DMSO

Exclusion Criteria:

  • Active infection
  • Urethral stricture

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bladder Thermal Distention (BTD)
Continuous irrigation of the bladder with warm saline (up to 45 Celsius) using the PelvixTT system
Procedure: Bladder Thermal Distention
Bladder Thermal Distention (BTD) is an approved procedure in Europe and Israel. Continuous irrigation of the bladder with warm saline with the PelvixTT system. The procedure will be performed on an outpatients basis. The procedure lasts 1 hour.
Other Names:
  • PelvixTT - Hyperthermia Elmedical LTD, Israel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
o'leary sant questionnaire
Time Frame: up to 1 year
o'leary sant questionnaire is a validated specific tool for evaluation of IC/PBS symptoms
up to 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bladder diary
Time Frame: up to 1 year
symptoms like urgency. frequency and functional voided volumes will be monitored
up to 1 year

Collaborators and Investigators

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

Sponsor

Assaf-Harofeh Medical Center

Investigators

  • Principal Investigator: Kobi Stav, MD, Assaf Harofe Medical Center

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, 2012

Primary Completion (Anticipated)

April 1, 2014

Study Completion (Anticipated)

April 1, 2014

Study Registration Dates

First Submitted

April 19, 2013

First Submitted That Met QC Criteria

April 23, 2013

First Posted (Estimate)

April 24, 2013

Study Record Updates

Last Update Posted (Estimate)

April 24, 2013

Last Update Submitted That Met QC Criteria

April 23, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 37/12

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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