We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01838486
Recruitment Status : Unknown
Verified April 2013 by Assaf-Harofeh Medical Center.
Recruitment status was:  Recruiting
First Posted : April 24, 2013
Last Update Posted : April 24, 2013
Sponsor:
Information provided by (Responsible Party):
Assaf-Harofeh Medical Center

Brief Summary:
Patients with Interstitial Cystitis / PBS will be treated with bladder thermal distention (BTD).

Condition or disease Intervention/treatment
Interstitial Cystitis Painful Bladder Syndrome Procedure: Bladder Thermal Distention

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  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bladder Thermal Distention for Patients With Interstitial Cystitis / Painful Bladder Syndrome
Study Start Date : June 2012
Estimated Primary Completion Date : April 2014
Estimated Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: PelvixTT - Hyperthermia Elmedical LTD, Israel



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Bladder diary [ Time Frame: up to 1 year ]
    symptoms like urgency. frequency and functional voided volumes will be monitored



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01838486


Contacts
Contact: Kobi Stav, MD 972-8-9779409 stavkobi@gmail.com

Locations
Israel
Assaf Harofe Medical Center Recruiting
Zerifin, Israel, 70300
Contact: Kobi Stav, MD       stavkobi@gmail.com   
Principal Investigator: Kobi Stav, MD         
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Investigators
Principal Investigator: Kobi Stav, MD Assaf Harofe Medical Center

Responsible Party: Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT01838486     History of Changes
Other Study ID Numbers: 37/12
First Posted: April 24, 2013    Key Record Dates
Last Update Posted: April 24, 2013
Last Verified: April 2013

Keywords provided by Assaf-Harofeh Medical Center:
Interstitial cystitis
painful bladder syndrome
bladder hydrodistention
hyperthermia

Additional relevant MeSH terms:
Syndrome
Pain
Cystitis
Cystitis, Interstitial
Disease
Pathologic Processes
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Urinary Bladder Diseases
Urologic Diseases