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

Not Applicable

• Conditions: Interstitial Cystitis; Painful Bladder Syndrome
• Interventions: Procedure: Bladder Thermal Distention

• Registration Number: NCT01838486
• Lead Sponsor: Assaf-Harofeh Medical Center

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2012-06
• Status Verified: 2013-04
• Study First Submitted: 2013-04-19
• Study First Submitted QC: 2013-04-23
• Last Update Submitted: 2013-04-23
• Study First Posted: 2013-04-24
• Last Update Posted: 2013-04-24
• Primary Completion: 2014-04
• Study Completion: 2014-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bladder Thermal Distention (BTD)	Bladder Thermal Distention	Continuous irrigation of the bladder with warm saline (up to 45 Celsius) using the PelvixTT system

Primary Outcome Measures

Name	Time	Method
o'leary sant questionnaire	up to 1 year	o'leary sant questionnaire is a validated specific tool for evaluation of IC/PBS symptoms

Secondary Outcome Measures

Name	Time	Method
Bladder diary	up to 1 year	symptoms like urgency. frequency and functional voided volumes will be monitored

Trial Locations

Locations (1)

Assaf Harofe Medical Center; 🇮🇱 Zerifin, Israel