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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Assaf-Harofeh Medical Center
Sponsor:
Information provided by (Responsible Party):
Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT01838486
First received: April 19, 2013
Last updated: April 23, 2013
Last verified: April 2013
  Purpose

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: Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  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 ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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

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

Additional relevant MeSH terms:
Cystitis
Dilatation, Pathologic
Pain
Cystitis, Interstitial
Urinary Bladder Diseases
Urologic Diseases
Pathological Conditions, Anatomical
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 31, 2014