Treatment of Interstitial Cystitis/Painful Bladder Syndrome Using Alternative Techniques: Exercis… (NCT00661050) | Clinical Trial Compass
WithdrawnNot Applicable
Treatment of Interstitial Cystitis/Painful Bladder Syndrome Using Alternative Techniques: Exercise, Meditation, Tai Chi
Stopped: Terminated due to low enrollment.
United States0Started 2008-04
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.