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

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.

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.

Interstitial cystitis, Painful bladder syndrome, Chronic pelvic pain, DMSO, 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.

60 treatments (12 weeks - 5 days a week) of hyperbaric (pressure of 2 atmospheres) with 100% oxygen inhalation.

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

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

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

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.