Bladder Thermal Distention for Patients With Refractory Overactive Bladder

Not Applicable

• Conditions: Overactive Bladder
• Interventions: Procedure: Bladder Thermal Distention

• Registration Number: NCT01842685
• Lead Sponsor: Assaf-Harofeh Medical Center

Brief Summary

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.

Detailed Description

Inclusion criteria:

1. Patients with overactive bladder syndrome

2. Detrusor Overactivity proven in urodynamic test

Exclusion criteria:

1. Mixed urinary incontinence

2. Active urinary tract infection

3. Urethral Stricture

Outcome measures:

1. Bladder Diaries

2. Urgency questionnaire

Study Timeline

• Status Verified: 2013-04
• Study Start: 2013-04
• Study First Submitted: 2013-04-14
• Study First Submitted QC: 2013-04-25
• Last Update Submitted: 2013-04-25
• Study First Posted: 2013-04-30
• Last Update Posted: 2013-04-30
• Primary Completion: 2014-03
• Study Completion: 2014-04

Recruitment & Eligibility

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

Inclusion Criteria

• Patients with overactive bladder syndrome
• Detrusor Overactivity proven in urodynamic test

Exclusion criteria:

• Mixed urinary incontinence
• Active urinary tract infection
• Urethral Stricture

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bladder Thermal Distention	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.

Primary Outcome Measures

Name	Time	Method
Urgency Questionnaire	up to 1 year	Patients will complete the validated USIQ questionnaire

Secondary Outcome Measures

Name	Time	Method
Daily frequency of micturitions on Bladder Diary	up to 1 year	Patients will complete bladder diaries before and after the procedure. Frequencies of micturitions per day will be documented

Trial Locations

Locations (1)

Assaf Harofe MC; 🇮🇱 Tel Aviv Region, Zeriffin, Israel