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

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:
NCT01842685
First received: April 14, 2013
Last updated: April 25, 2013
Last verified: April 2013
  Purpose

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  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: 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
  More Information

No publications provided

Responsible Party: Assaf-Harofeh Medical Center
ClinicalTrials.gov 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:
Dilatation, Pathologic
Urinary Bladder, Overactive
Lower Urinary Tract Symptoms
Pathological Conditions, Anatomical
Signs and Symptoms
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations

ClinicalTrials.gov processed this record on November 27, 2014