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 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT02173405
Eligibility Criteria:
Inclusion Criteria:
1. Females age 18 years to 65 years
2. MPP for at least 6 months with pain ranked \> 7/10 by VAS
3. Able to make medical decisions for herself
4. Ability to speak and understand English
5. Ability to follow study instructions and likely to complete all required visits 6 .Must give written informed consent before enrolment in this study
Exclusion Criteria:
1. Pelvic onabotulinumA injections within the last 6 months
2. Pelvic floor physical therapy (PFPT) within the last 1 months
3. Pelvic surgery within the last 1 year
4. PVR greater than 150 ml
5. Presence of interstitial cystitis/ painful bladder syndrome (IC/PBS) by the current The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) criteria 37.
6. Evidence of pelvic pathology or other active diagnoses of acute or chronic pain syndromes including endometriosis, chronic cystitis, acute urinary tract infection, vaginitis, pelvic inflammatory disease, etc.
7. Breastfeeding, pregnant or contemplating pregnancy in the next 1 year or not on a current reliable form of birth control
8. Patients with known neurological diseases involving impaired neurotransmission, including myasthenia gravis and Charcot-Marie-Tooth disease
9. Patients who are on ambulatory anticoagulant therapy, including aspirin, who are unable to discontinue this treatment for 24 hours prior to the bladder injection
10. Women taking aminoglycosides at the time of injection (i.e. Cipro)
12\. Uncontrolled clinically significant medical condition other than the condition under investigation 13. Known allergy or sensitivity to any of the components in the study medication 14. Concurrent or past (within 1 months) participation in another investigational drug or device study 15. Any condition or situation that, in the investigators opinion, may put the patients at significant risk, confound the study results, or interfere significantly with the patients participation in the study
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02173405
Study Brief:
Protocol Section:
NCT02173405