Bladder Thermal Distention for Patients With Interstitial Cystitis / Painful Bladder Syndrome (IC)
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|ClinicalTrials.gov Identifier: NCT01838486|
Recruitment Status : Unknown
Verified April 2013 by Assaf-Harofeh Medical Center.
Recruitment status was: Recruiting
First Posted : April 24, 2013
Last Update Posted : April 24, 2013
|Condition or disease||Intervention/treatment||Phase|
|Interstitial Cystitis Painful Bladder Syndrome||Procedure: Bladder Thermal Distention||Not Applicable|
In this study we will evaluate the efficacy of bladder thermal distention (BTD) in patients with IC/PBS.
Patients with previous failed conventional treatment (intravesical DMSO) will be recruited.
|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 Interstitial Cystitis / Painful Bladder Syndrome|
|Study Start Date :||June 2012|
|Estimated Primary Completion Date :||April 2014|
|Estimated Study Completion Date :||April 2014|
Experimental: Bladder Thermal Distention (BTD)
Continuous irrigation of the bladder with warm saline (up to 45 Celsius) using the PelvixTT system
Procedure: Bladder Thermal Distention
Bladder Thermal Distention (BTD) is an approved procedure in Europe and Israel. Continuous irrigation of the bladder with warm saline with the PelvixTT system. The procedure will be performed on an outpatients basis. The procedure lasts 1 hour.
Other Name: PelvixTT - Hyperthermia Elmedical LTD, Israel
- o'leary sant questionnaire [ Time Frame: up to 1 year ]o'leary sant questionnaire is a validated specific tool for evaluation of IC/PBS symptoms
- Bladder diary [ Time Frame: up to 1 year ]symptoms like urgency. frequency and functional voided volumes will be monitored
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): NCT01838486
|Contact: Kobi Stav, MDfirstname.lastname@example.org|
|Assaf Harofe Medical Center||Recruiting|
|Zerifin, Israel, 70300|
|Contact: Kobi Stav, MD email@example.com|
|Principal Investigator: Kobi Stav, MD|
|Principal Investigator:||Kobi Stav, MD||Assaf Harofe Medical Center|