Bladder Thermal Distention for Patients With Refractory Overactive Bladder (OAB)
Recruitment status was: Recruiting
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.
|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|
- Urgency Questionnaire [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]Patients will complete the validated USIQ questionnaire
- 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
|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)|
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
- Patients with overactive bladder syndrome
- Detrusor Overactivity proven in urodynamic test
- Mixed urinary incontinence
- Active urinary tract infection
- Urethral Stricture
- Bladder Diaries
- Urgency questionnaire
Please refer to this study by its ClinicalTrials.gov identifier: NCT01842685
|Assaf Harofe MC|
|Tel Aviv Region, Zeriffin, Israel, 70300|
|Principal Investigator:||Kobi Stav, MD||Assaf Harofe MC|