Bladder Thermal Distention for Patients With Refractory Overactive Bladder

Overactive Bladder Clinical Trial

— OAB  

Official title:

Bladder Thermal Distention for Patients With Refractory Overactive Bladder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01842685
• Other study ID #: 216/12
• Status: Recruiting
• Phase: N/A
• First received: April 14, 2013
• Last updated: April 25, 2013
• Start date: April 2013
• Est. completion date: April 2014

Study information

• Verified date: April 2013
• Source: Assaf-Harofeh Medical Center
• Contact: Kobi Stav, MD
• Phone: 972-8-9778461
• Email: stavkobi[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: April 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with overactive bladder syndrome

• Detrusor Overactivity proven in urodynamic test

Exclusion criteria:

• Mixed urinary incontinence

• Active urinary tract infection

• Urethral Stricture

Study Design

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

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

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.

Locations

Country	Name	City	State
Israel	Assaf Harofe MC	Tel Aviv Region	Zeriffin

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	Urgency Questionnaire	Patients will complete the validated USIQ questionnaire	up to 1 year	No
Secondary	Daily frequency of micturitions on Bladder Diary	Patients will complete bladder diaries before and after the procedure. Frequencies of micturitions per day will be documented	up to 1 year	No