Comparative Study Between Hyperbaric Therapy and Intravesical Dimethyl Sulfoxide Instillation for Interstitial Cystitis

Not Applicable

• Conditions: Interstitial Cystitis
• Interventions: Drug: DMSO; Other: Hyperbaric Oxygen Therapy

• Registration Number: NCT01069263
• Lead Sponsor: Assaf-Harofeh Medical Center

Brief Summary

The purpose of this study is to compare the efficacy of hyperbaric oxygen therapy (HBOT) to intravesical Dimethyl Sulfoxide (DMSO) instillation for the treatment of patients who suffers from Interstitial Cystitis / Painful bladder syndrome.

Detailed Description

Interstitial cystitis / painful bladder syndrome (IC/PBS) presents as a pelvic pain condition associated with urinary urgency and frequency. These symptoms impair significantly the patient's quality of life. The etiology is yet not obvious. The current acceptable theory is injury or dysfunction of the Mucus (Glycosaminoglycans) layer that covers the inner surface of the urinary bladder. Abnormal diffusion of toxins from the urine to the walls of the bladder leads to inflammation, pain and scarring.

Many types of treatments were described but most of them were not evaluated in well designed randomized controlled studies. For now, there is no one single treatment that gives good outcome to every patient. Therefore, the treatment of patients with IC/PBS is challenging. In this study, we will compare the efficacy of hyperbaric oxygen therapy (HBOT) to intravesical dimethyl sulfoxide (DMSO) instillation for the treatment of patients who suffers from IC/PBS.

Patients with IC (NIDDK criteria) will be randomized to have either DMSO instillation or HBOT.

Before and after treatments the patients will fill out questionnaires (O'Leary-Sant Interstitial Cystitis Symptom and Problem Index), visual analogue scale for pain and bladder diaries. In addition, urodynamics will be performed before and after treatments. In case of incomplete symptoms remission, patients will be crossed over to have the other treatment.

Study Timeline

• Study First Submitted: 2010-01-10
• Status Verified: 2010-02
• Study Start: 2010-02
• Study First Submitted QC: 2010-02-15
• Study First Posted: 2010-02-17
• Last Update Submitted: 2011-04-04
• Last Update Posted: 2011-04-05
• Primary Completion: 2015-03
• Study Completion: 2015-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• NIDDK diagnosis of interstitial cystitis

Exclusion Criteria

• Previous treatment of hyperbaric therapy
• Contraindication for hyperbaric therapy (mid-ear pathology, abnormal chest X-ray, Claustrophobia, pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Intravesical DMSO instillation	DMSO	50 mls of 50% DMSO instilled once a week to the urinary bladder for 12 consecutive weeks.
Hyperbaric Oxygen Therapy (HBOT)	Hyperbaric Oxygen Therapy	Overall 60 treatments (5 days per weeks for 12 weeks). 90 minutes every session. Pressure of 2 atm. Inhalation of 100% oxygen.

Primary Outcome Measures

Name	Time	Method
Subjective improvement will be assessed by several questionnaires: the Oleary Sant symptom index score, bladder diary, 1-10 visual analogue scale for pain, PSQ4 questionnaire	1-4 weeks post treatment

Secondary Outcome Measures

Name	Time	Method
Objective improvement will be assessed by urodynamic test. The following parameters will be addressed: cystometric capacity, 1st sensation, normal sensation	1-4 weeks post treatment

Trial Locations

Locations (1)

Assaf Harofe Medical Center; 🇮🇱 Zeriffin, Israel