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Bladder Thermal Distention for Patients With Refractory Overactive Bladder

NCT ID: NCT01842685

Last Updated: 2013-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-04-30

Brief Summary

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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

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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

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Overactive Bladder

Keywords

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Overactive Bladder Bladder Distention

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Bladder Thermal Distention

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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PelvixTT - Hyperthermia Elmedical LTD, Israel

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Mixed urinary incontinence
* Active urinary tract infection
* Urethral Stricture
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kobi Stav, MD

Role: PRINCIPAL_INVESTIGATOR

Assaf Harofe MC

Locations

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Assaf Harofe MC

Tel Aviv Region, Zeriffin, Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Kobi Stav, MD

Role: CONTACT

Phone: 972-8-9778461

Email: [email protected]

Facility Contacts

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Kobi Stav, MD

Role: primary

Other Identifiers

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216/12

Identifier Type: -

Identifier Source: org_study_id