Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2025-12-24 @ 4:51 PM
NCT ID:
NCT00661050
Eligibility Criteria:
Inclusion Criteria:
1. Participant has signed and dated the appropriate Informed Consent document.
2. Participant is equal or \> 18 years old
3. Participant has a clinical diagnosis of IC/PBS and or CP/CPPS in the opinion of the investigator
4. 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.
5. 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.
6. 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.
7. Participant has previously undergone at least one course of other form of standard therapy for his/her symptoms Exclusion Criteria:1. Participant can not stand in place for at least 15 minutes.
Exclusion Criteria:
1. Participants have severe lower extremity disease that would prohibit participation in walking or Tai Chi movements.
2. Participant cannot hold urine for at least 30 minutes
3. Participant has relevant neurologic disorder that affects bladder and/or neuromuscular function in the opinion of the investigator.
4. Participant has active urethral or ureteral calculi, urethral diverticulum.
5. Participant has a history of pelvic radiation therapy, tuberculous cystitis, bladder cancer, carcinoma in situ, prostate cancer, or urethral cancer.
6. Participant has/reports any severe debilitating or urgent concurrent medical condition.
7. 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00661050
Study Brief:
Protocol Section:
NCT00661050