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

Assaf-Harofeh Medical Center20 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Interstitial Cystitis Painful Bladder Syndrome

Interventions

Bladder Thermal DistentionPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Assaf Harofe Medical Center

Ẕerifin, Israel

RECRUITING

Outcomes

Primary Outcomes

o'leary sant questionnaire

o'leary sant questionnaire is a validated specific tool for evaluation of IC/PBS symptoms

Time frame: up to 1 year

Secondary Outcomes

Bladder diary

symptoms like urgency. frequency and functional voided volumes will be monitored

Time frame: up to 1 year

Central Contacts

Kobi Stav, MD

CONTACT

972-8-9779409 stavkobi@gmail.com

Data from ClinicalTrials.gov

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