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

NCT00661050 | Withdrawn

• 2 other identifiers: SU-03132008-104111838
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystitis, Interstitial

Interventions

Alternative Medicine PROCEDURE

Tai Chi instruction and class participation or walking exercise and sitting meditation PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

IC Patients from Stanford University Urology Clinic's patient population.

You may qualify if:

• Participant has signed and dated the appropriate Informed Consent document.
• Participant is equal or \> 18 years old
• Participant has a clinical diagnosis of IC/PBS and or CP/CPPS in the opinion of the investigator
• Participant with IC/PBS has reported a bladder pain or discomfort symptom score of 3 or greater on a 0-10 Likert scale over the previous four weeks. This bladder pain/discomfort criterion must be met at each of the two baseline screening visits as reported by the participant.
• Participant with IC/PBS has reported a symptom score of abnormal urinary frequency of 3 or greater on 0-10 Likert scale over the previous four weeks. This frequency criterion must be met at least each of the two baseline screening visits.
• Participant has had symptoms of discomfort or pain in the pelvic region for at least a three (3) month period within the last six (6) months.

You may not qualify if:

• Participants have severe lower extremity disease that would prohibit participation in walking or Tai Chi movements.
• Participant cannot hold urine for at least 30 minutes
• Participant has relevant neurologic disorder that affects bladder and/or neuromuscular function in the opinion of the investigator.
• Participant has active urethral or ureteral calculi, urethral diverticulum.
• Participant has a history of pelvic radiation therapy, tuberculous cystitis, bladder cancer, carcinoma in situ, prostate cancer, or urethral cancer.
• Participant has/reports any severe debilitating or urgent concurrent medical condition.
• Participant has a potentially significant pelvic pathology or abnormalities on examination or prior imaging, including prolapse beyond the hymenal ring, pelvic mass, etc. that could cause or contribute to the clinical symptoms or require treatment.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Cystitis, Interstitial

Interventions

Complementary Therapies

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Chris Payne

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2008
• First Posted: April 18, 2008
• Study Start: April 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: April 12, 2024

Record last verified: 2011-03

Locations

US (1)