Bladder Thermal Distention for Patients With Interstitial Cystitis / Painful Bladder Syndrome

NCT ID: NCT01838486

Last Updated: 2013-04-24

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

2012-06-30

Study Completion Date

2014-04-30

Brief Summary

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Patients with Interstitial Cystitis / PBS will be treated with bladder thermal distention (BTD).

Detailed Description

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In this study we will evaluate the efficacy of bladder thermal distention (BTD) in patients with IC/PBS.

Patients with previous failed conventional treatment (intravesical DMSO) will be recruited.

Conditions

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Interstitial Cystitis Painful Bladder Syndrome

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 (BTD)

Continuous irrigation of the bladder with warm saline (up to 45 Celsius) using the PelvixTT system

Group Type EXPERIMENTAL

Bladder Thermal Distention

Intervention Type PROCEDURE

Bladder Thermal Distention (BTD) is an approved procedure in Europe and Israel. Continuous irrigation of the bladder with warm saline with the PelvixTT system. The procedure will be performed on an outpatients basis. The procedure lasts 1 hour.

Interventions

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Bladder Thermal Distention

Bladder Thermal Distention (BTD) is an approved procedure in Europe and Israel. Continuous irrigation of the bladder with warm saline with the PelvixTT system. The procedure will be performed on an outpatients basis. The procedure lasts 1 hour.

Intervention Type PROCEDURE

Other Intervention Names

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PelvixTT - Hyperthermia Elmedical LTD, Israel

Eligibility Criteria

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Inclusion Criteria

-All patients with interstitial cystitis / painful bladder syndrome (IC/PBS) who had previous intravesical treatment with DMSO

Exclusion Criteria

* Active 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 Medical Center

Locations

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Assaf Harofe Medical Center

Ẕerifin, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Kobi Stav, MD

Role: CONTACT

972-8-9779409

Facility Contacts

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Kobi Stav, MD

Role: primary

Other Identifiers

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37/12

Identifier Type: -

Identifier Source: org_study_id

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