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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2013 by Assaf-Harofeh Medical Center.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Assaf-Harofeh Medical Center Identifier:
First received: April 19, 2013
Last updated: April 23, 2013
Last verified: April 2013
Patients with Interstitial Cystitis / PBS will be treated with bladder thermal distention (BTD).

Condition Intervention
Interstitial Cystitis
Painful Bladder Syndrome
Procedure: Bladder Thermal Distention

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Bladder Thermal Distention for Patients With Interstitial Cystitis / Painful Bladder Syndrome

Resource links provided by NLM:

Further study details as provided by Assaf-Harofeh Medical Center:

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

Estimated Enrollment: 20
Study Start Date: June 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


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

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01838486

Assaf Harofe Medical Center
Zerifin, Israel, 70300
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Principal Investigator: Kobi Stav, MD Assaf Harofe Medical Center
  More Information

Responsible Party: Assaf-Harofeh Medical Center Identifier: NCT01838486     History of Changes
Other Study ID Numbers: 37/12 
Study First Received: April 19, 2013
Last Updated: April 23, 2013

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

Additional relevant MeSH terms:
Cystitis, Interstitial
Pathologic Processes
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Urinary Bladder Diseases
Urologic Diseases processed this record on February 20, 2017