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Bladder Thermal Distention for Patients With Refractory Overactive Bladder (OAB)

Primary Purpose

Overactive Bladder

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Bladder Thermal Distention
Sponsored by
Assaf-Harofeh Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring Overactive Bladder, Bladder Distention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion criteria:

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

Sites / Locations

  • Assaf Harofe MCRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bladder Thermal Distention

Arm Description

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.

Outcomes

Primary Outcome Measures

Urgency Questionnaire
Patients will complete the validated USIQ questionnaire

Secondary Outcome Measures

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

Full Information

First Posted
April 14, 2013
Last Updated
April 25, 2013
Sponsor
Assaf-Harofeh Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01842685
Brief Title
Bladder Thermal Distention for Patients With Refractory Overactive Bladder
Acronym
OAB
Official Title
Bladder Thermal Distention for Patients With Refractory Overactive Bladder
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Unknown status
Study Start Date
April 2013 (undefined)
Primary Completion Date
March 2014 (Anticipated)
Study Completion Date
April 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assaf-Harofeh Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: Patients with overactive bladder syndrome Detrusor Overactivity proven in urodynamic test Exclusion criteria: Mixed urinary incontinence Active urinary tract infection Urethral Stricture Outcome measures: Bladder Diaries Urgency questionnaire

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
Keywords
Overactive Bladder, Bladder Distention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bladder Thermal Distention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Bladder Thermal Distention
Other Intervention Name(s)
PelvixTT - Hyperthermia Elmedical LTD, Israel
Intervention Description
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.
Primary Outcome Measure Information:
Title
Urgency Questionnaire
Description
Patients will complete the validated USIQ questionnaire
Time Frame
up to 1 year
Secondary Outcome Measure Information:
Title
Daily frequency of micturitions on Bladder Diary
Description
Patients will complete bladder diaries before and after the procedure. Frequencies of micturitions per day will be documented
Time Frame
up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with overactive bladder syndrome Detrusor Overactivity proven in urodynamic test Exclusion criteria: Mixed urinary incontinence Active urinary tract infection Urethral Stricture
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kobi Stav, MD
Phone
972-8-9778461
Email
stavkobi@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kobi Stav, MD
Organizational Affiliation
Assaf Harofe MC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assaf Harofe MC
City
Tel Aviv Region
State/Province
Zeriffin
ZIP/Postal Code
70300
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kobi Stav, MD
Phone
972-8-9779400
Email
stavkobi@gmail.com
First Name & Middle Initial & Last Name & Degree
Kobi Stav, MD

12. IPD Sharing Statement

Learn more about this trial

Bladder Thermal Distention for Patients With Refractory Overactive Bladder

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