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Bladder Thermal Distention for Patients With Refractory Overactive Bladder (OAB)

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 14, 2013
Last updated: April 25, 2013
Last verified: April 2013

In this study, the investigators will evaluate the efficacy of Bladder Thermal Distention (BTD) in patients with overactive bladder syndrome who failed previous treatment of anticholinergic drugs.

The investigators' hypothesis is that it will improve the storage symptoms.

Condition Intervention
Overactive Bladder
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 Refractory Overactive Bladder

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Urgency Questionnaire [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
    Patients will complete the validated USIQ questionnaire

Secondary Outcome Measures:
  • Daily frequency of micturitions on Bladder Diary [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
    Patients will complete bladder diaries before and after the procedure. Frequencies of micturitions per day will be documented

Estimated Enrollment: 20
Study Start Date: April 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bladder Thermal Distention
Continuous irrigation of the bladder with warm saline (up to 45 Celsius) using a specific 3 ways catheter. The procedure will last 1 hour. Saline will be irrigated by the PelvixTT system.
Procedure: Bladder Thermal Distention
Bladder Thermal Distention is an approved procedure in Europe from 2006. The treatment is hydrodistention of the bladder with a warm saline (up to 45C). The procedure lasts 1 hour. The saline is infused constantly through a 3 ways specific catheter (Unithermia 18F) by the PelvixTT system.
Other Name: PelvixTT - Hyperthermia Elmedical LTD, Israel

Detailed Description:

Inclusion criteria:

  1. Patients with overactive bladder syndrome
  2. Detrusor Overactivity proven in urodynamic test

Exclusion criteria:

  1. Mixed urinary incontinence
  2. Active urinary tract infection
  3. Urethral Stricture

Outcome measures:

  1. Bladder Diaries
  2. Urgency questionnaire

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

Inclusion Criteria:

  • Patients with overactive bladder syndrome
  • Detrusor Overactivity proven in urodynamic test

Exclusion criteria:

  • Mixed urinary incontinence
  • Active urinary tract 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: NCT01842685

Assaf Harofe MC
Tel Aviv Region, Zeriffin, Israel, 70300
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Principal Investigator: Kobi Stav, MD Assaf Harofe MC
  More Information

Responsible Party: Assaf-Harofeh Medical Center Identifier: NCT01842685     History of Changes
Other Study ID Numbers: 216/12 
Study First Received: April 14, 2013
Last Updated: April 25, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Assaf-Harofeh Medical Center:
Overactive Bladder
Bladder Distention

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Dilatation, Pathologic
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Pathological Conditions, Anatomical processed this record on December 02, 2016