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

Comparison Between Hyperbaric Oxygen Therapy (HBOT) and Intravesical Dimethyl Sulfoxide (DMSO) Instillation for the Treatment of Interstitial Cystitis - a Prospective, Randomized Cross-over Trial

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.

Study Overview

• Status: Unknown
• Conditions: Interstitial Cystitis
• Intervention / Treatment: Drug: DMSO; Other: Hyperbaric Oxygen Therapy

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Zeriffin, Israel, 70300
    • Recruiting
    • Assaf Harofe Medical Center
    • Contact: Shay Efrati, MD; Phone Number: +972-577346364; Email: efratishai@013.net
    • Contact: Kobi Stav, MD; Phone Number: +972-577346778; Email: stavkobi@yahoo.com.au

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intravesical DMSO instillation; 50 mls of 50% DMSO instilled once a week to the urinary bladder for 12 consecutive weeks.	Drug: DMSO; 50 mls of 50% DMSO instilled once a week to the urinary bladder for 12 consecutive weeks.; Other Names: dimethyl sulfoxide
Experimental: Hyperbaric Oxygen Therapy (HBOT); Overall 60 treatments (5 days per weeks for 12 weeks). 90 minutes every session. Pressure of 2 atm. Inhalation of 100% oxygen.	Other: Hyperbaric Oxygen Therapy; 60 treatments (12 weeks - 5 days a week) of hyperbaric (pressure of 2 atmospheres) with 100% oxygen inhalation.; Other Names: Hyperbaric chamber; HBOT; Hyperbaric therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Assaf-Harofeh Medical Center
• Investigators: Principal Investigator: Kobi Stav, MD, Assaf Harofe Medical Center

Publications and helpful links

General Publications

• Perez-Marrero R, Emerson LE, Feltis JT. A controlled study of dimethyl sulfoxide in interstitial cystitis. J Urol. 1988 Jul;140(1):36-9. doi: 10.1016/s0022-5347(17)41478-9.
• van Ophoven A, Rossbach G, Oberpenning F, Hertle L. Hyperbaric oxygen for the treatment of interstitial cystitis: long-term results of a prospective pilot study. Eur Urol. 2004 Jul;46(1):108-13. doi: 10.1016/j.eururo.2004.03.002.

Helpful Links

• international painful bladder foundation
• Interstitial Cystitis Association

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Anticipated): March 1, 2015
• Study Completion (Anticipated): July 1, 2015

Study Registration Dates

• First Submitted: January 10, 2010
• First Submitted That Met QC Criteria: February 15, 2010
• First Posted (Estimate): February 17, 2010

Study Record Updates

• Last Update Posted (Estimate): April 5, 2011
• Last Update Submitted That Met QC Criteria: April 4, 2011
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Keywords: Interstitial cystitis; Chronic pelvic pain; DMSO; Hyperbaric oxygen therapy; Painful bladder syndrome
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Cystitis; Cystitis, Interstitial; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Antioxidants; Free Radical Scavengers; Cryoprotective Agents; Dimethyl Sulfoxide
• Other Study ID Numbers: 04/10