NCT01842685

Bladder Thermal Distention for Patients With Refractory Overactive Bladder

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Assaf-Harofeh Medical Center · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Overactive Bladder

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-04-01
• Primary completion: 2014-03-01
• Completion: 2014-04-01
• First posted: 2013-04-30
• Last updated: 2013-04-30

Locations

1 site across 1 country: Israel