Clinical Trial: Treatment of Interstitial Cystitis/Painful Bladder Syndrome Using Alternative Techniques: Exercise, Meditation, Tai Chi

Study Status: Terminated
Recruit Status: Terminated
Study Type: Observational

Official Title: Exercise and Meditation: A Pilot Study of Alternative Techniques in the Treatment of Chronic Pelvic Pain Related to Painful Bladder Syndrome (PBS)/Interstitial Cystitis (I

Brief Summary: Complementary and alternative medicine (CAM) is the term for medical products and/or practices that are not part of the current standard of care. Standard care is what medical doctors, doctors of osteopathy and allied health professionals, such as registered nurses and physical therapists, practice. Alternative medicine means treatments that you use instead of standard ones. Complementary medicine means nonstandard treatments that you use along with standard ones. The purpose of this study is to determine whether there is any improvement in symptoms reported by patients with chronic painful bladder syndrome when participating in alternative medical therapy/ exercise and meditative techniques. The specific alternative techniques participants will be randomized to in this trial include: Tai Chi instruction or walking exercise combined with sitting meditation.

Detailed Summary:

Participants will be referred for trial screening if they have a diagnosis of painful bladder syndrome/IC in the opinion of the investigator. Participants will be required to read the informed consent form and sign it prior to the screening of any medical information. The eligibility criteria will be reviewed and participants who qualify will complete the visit one study screening procedures. Participants will be asked to track there daily pain level and medication use for 7 days prior to randomization an in addition will be required to complete one 24-hour void diary during this same screening time period. Participants will be asked to give a urine sample on the day of screening and the day of randomization to screen for bladder infection. Female participants will be asked to provide a urine sample for pregnancy testing prior to randomization.

Participants will be required to be on a stable medical regime for 30 days prior to randomization. No new IC therapy or new pain treatments will be allowed to begin during the screening period and/or the 3 month study trial period. Participants will be allowed to continue on any IC/pain therapy they have used prior to screening.

Randomization to the treatment groups will occur 5-7 days prior to treatment start date. At that visit the patient#s medical history will be reviewed for eligibility and adverse events. The recorded pain scores collected and all quality of life measurements obtained. Participants who continue to qualify will be randomized to the specified treatment group.

Once 12 participants have been screened and are ready for randomization the participants will be scheduled for the randomization visit--Participants assigned to the Tai Chi group will be instructed on the logistics of the class, participants in this group wi
Sponsor: Stanford University

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Stanford University

Dates:
Date Received: April 4, 2008
Date Started: April 2008
Date Completion:
Last Updated: March 18, 2011
Last Verified: March 2011