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

Sponsor

Assaf-Harofeh Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT01069263

Collaborator

(none)

Enrollment

Location

Arms

64.9

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Interstitial Cystitis	Other: Hyperbaric Oxygen Therapy Drug: DMSO	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Feb 1, 2010

Anticipated Primary Completion Date :

Mar 1, 2015

Anticipated Study Completion Date :

Jul 1, 2015

Arms and Interventions

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: HBOT Hyperbaric chamber Hyperbaric therapy

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:

HBOT

Hyperbaric chamber

Hyperbaric therapy

Outcome Measures

Primary Outcome Measures

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

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]