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 @ 12:07 PM
Ignite Modification Date:
2025-12-24 @ 12:07 PM
NCT ID:
NCT01410461
Eligibility Criteria:
Inclusion Criteria:
1. age \> 18 years old
2. urinary frequency of at least 10 per 24 hr including one nighttime voiding
3. complaints of bladder pain that has been present for at least 3 months
4. pain intensity rated at least four on a VAS from 0 ''no pain at all'' to 10 ''worst imaginable pain'' during the previous month
5. pelvic digital exam reveals at least three different TrPs in the levator ani muscles that are verbally confirmed.
Exclusion criteria:
1. history of pelvic cancer or radiation
2. pelvic or abdominal surgery within 3 months
3. urinary tract infection within the last month
4. diagnosis of fibromyalgia or irritable bowel disease
5. diagnosis of neurologic disorder; diabetes; pregnancy;
6. pelvic pain and/ or urgency symptoms presented only during menses.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01410461
Study Brief:
Protocol Section:
NCT01410461