Comparison Between Hyperbaric Oxygen Therapy (HBOT) and Intravesical Dimethyl Sulfoxide (DMSO) Instillation for the Treatment of Interstitial Cystitis – a Prospective, Randomized Cross-over Trial
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.
Condition:
Interstitial Cystitis
Treatment:
Hyperbaric Oxygen Therapy
Start Date:
February 2010
Sponsor:
Assaf-Harofeh Medical Center
For More Information:
https://clinicaltrials.gov/show/NCT01069263