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

Information source: Assaf-Harofeh Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Interstitial Cystitis

Intervention: Hyperbaric Oxygen Therapy (Other); DMSO (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Assaf-Harofeh Medical Center

Official(s) and/or principal investigator(s):
Kobi Stav, MD, Principal Investigator, Affiliation: Assaf Harofe Medical Center

Overall contact:
Kobi Stav, MD, Phone: +972-89779400, Email: stavkobi@yahoo.com.au

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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

Secondary outcome: Objective improvement will be assessed by urodynamic test. The following parameters will be addressed: cystometric capacity, 1st sensation, normal sensation

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.

Eligibility

Minimum age: 18 Years. Maximum age: 85 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Kobi Stav, MD, Phone: +972-89779400, Email: stavkobi@yahoo.com.au

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

International Painful Bladder Foundation

Interstitial Cystitis Association

Related 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.

Starting date: February 2010
Last updated: April 4, 2011

Page last updated: August 23, 2015

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