Bladder Thermal Distention for Patients With Refractory Overactive Bladder (OAB)
|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
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||Phase|
|Overactive Bladder||Procedure: Bladder Thermal Distention||Not Applicable|
- Patients with overactive bladder syndrome
- Detrusor Overactivity proven in urodynamic test
- Mixed urinary incontinence
- Active urinary tract infection
- Urethral Stricture
- Bladder Diaries
- Urgency questionnaire
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- Urgency Questionnaire [ Time Frame: up to 1 year ]Patients will complete the validated USIQ questionnaire
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01842685
|Contact: Kobi Stav, MDfirstname.lastname@example.org|
|Assaf Harofe MC||Recruiting|
|Tel Aviv Region, Zeriffin, Israel, 70300|
|Contact: Kobi Stav, MD 972-8-9779400 email@example.com|
|Principal Investigator: Kobi Stav, MD|
|Principal Investigator:||Kobi Stav, MD||Assaf Harofe MC|