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NCT01838486 Clinical Trial

Bladder Thermal Distention for Patients With Interstitial Cystitis / Painful Bladder Syndrome

Interstitial Cystitis Clinical Trial

— IC  

Official title:
Bladder Thermal Distention for Patients With Interstitial Cystitis / Painful Bladder Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01838486
Other study ID # 37/12
Secondary ID
Status Recruiting
Phase N/A
First received April 19, 2013
Last updated April 23, 2013
Start date June 2012
Est. completion date April 2014

Study information
Verified date April 2013
Source Assaf-Harofeh Medical Center
Contact Kobi Stav, MD
Phone 972-8-9779409
Email stavkobi@gmail.com
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial Summary

Patients with Interstitial Cystitis / PBS will be treated with bladder thermal distention (BTD).

Description:

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date April 2014
Est. primary completion date April 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

-All patients with interstitial cystitis / painful bladder syndrome (IC/PBS) who had previous intravesical treatment with DMSO

Exclusion Criteria:

- Active infection

- Urethral stricture

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Israel Assaf Harofe Medical Center Zerifin

Sponsors (1)
Lead Sponsor Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary o'leary sant questionnaire o'leary sant questionnaire is a validated specific tool for evaluation of IC/PBS symptoms up to 1 year No
Secondary Bladder diary symptoms like urgency. frequency and functional voided volumes will be monitored up to 1 year No
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