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:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-25 @ 3:45 AM
NCT ID:
NCT05062902
Eligibility Criteria:
Inclusion Criteria:
* Inclusion criteria for interstitial cystitis/bladder pain syndrome (IC/BPS) patients will be:
1. Woman aged 18 to 60.
2. Have a clinical diagnosis of IC/BPS.
3. Pain, pressure, or discomfort in the bladder and/or pelvic area for the past 6 months or more, associated with lower urinary tract symptoms (such as frequency of urination), in the absence of other explanation of the symptoms (e.g., urinary tract infection).
4. Myofascial pain diagnosed with palpable contracted muscle fibers.
5. Pelvic muscle tenderness by assessment of pelvic floor muscles on digital pelvic examination.
6. Pelvic floor hypertonicity (PFH), measured using vaginal manometry (pressure \> 35 cm∙H2O).
7. Ability to provide informed consent.
Exclusion Criteria:
* Exclusion criteria consist of the following:
1. History of pelvic malignancy and sexually transmitted diseases.
2. Bleeding disorder such as coagulopathy
3. History of neurological disorders, such as spinal cord injury, multiple sclerosis, amyotrophic lateral sclerosis or myasthenia gravis.
4. Pregnancy, breast feeding or desiring for pregnancy in the coming year.
5. Subjects with history of pelvic surgery (e.g., pain from mid-urethral sling or pelvic mesh),
6. Pelvic malignancy (urinary tract, gynecologic, gastrointestinal)
7. Active fistula
8. Radiation cystitis
9. Cyclophosphamide cystitis
10. Pre-existing anorectal disorders
11. Infections near the injection sites
12. History of drug or alcohol abuse
13. Hypersensitivity to BoNT
14. Steroids or hormone usage will be carefully considered by the research team for inclusion.
Participants with on-going BoNT therapies will not be screened until the complete drug washout is confirmed.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT05062902
Study Brief:
Protocol Section:
NCT05062902