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

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: NCT01842685
Recruitment Status : Unknown
Verified April 2013 by Assaf-Harofeh Medical Center.
Recruitment status was:  Recruiting
First Posted : April 30, 2013
Last Update Posted : April 30, 2013
Sponsor:
Information provided by (Responsible Party):
Assaf-Harofeh Medical Center

Brief Summary:

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 or disease Intervention/treatment
Overactive Bladder Procedure: Bladder Thermal Distention

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

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 Refractory Overactive Bladder
Study Start Date : April 2013
Estimated Primary Completion Date : March 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
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



Primary Outcome Measures :
  1. Urgency Questionnaire [ Time Frame: up to 1 year ]
    Patients will complete the validated USIQ questionnaire


Secondary Outcome Measures :
  1. Daily frequency of micturitions on Bladder Diary [ Time Frame: up to 1 year ]
    Patients will complete bladder diaries before and after the procedure. Frequencies of micturitions per day will be documented



Information from the National Library of Medicine

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

Inclusion Criteria:

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

Exclusion criteria:

  • Mixed urinary incontinence
  • Active urinary tract 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): NCT01842685


Contacts
Contact: Kobi Stav, MD 972-8-9778461 stavkobi@gmail.com

Locations
Israel
Assaf Harofe MC Recruiting
Tel Aviv Region, Zeriffin, Israel, 70300
Contact: Kobi Stav, MD    972-8-9779400    stavkobi@gmail.com   
Principal Investigator: Kobi Stav, MD         
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Investigators
Principal Investigator: Kobi Stav, MD Assaf Harofe MC

Responsible Party: Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT01842685     History of Changes
Other Study ID Numbers: 216/12
First Posted: April 30, 2013    Key Record Dates
Last Update Posted: April 30, 2013
Last Verified: April 2013

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