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 @ 11:46 AM
Ignite Modification Date:
2025-12-24 @ 11:46 AM
NCT ID:
NCT03123861
Eligibility Criteria:
Inclusion Criteria:
* Women age 18+
* English-speaking
* Planning to undergo a vaginal SSLF
Exclusion Criteria:
* Pregnant or planning to become pregnant during study participation
* Prior vaginal mesh surgery for pelvic organ prolapse
* Planning a concurrent total vaginal hysterectomy, colpocleisis (total vaginectomy or LeFort colpocleisis), mesh excision, anal sphincteroplasty, fistula repair, or urethral diverticulectomy
* Cognitive impairment (indicated by a score of 0-2 on Mini-Cog)
* Currently taking gabapentin or pregabalin (Lyrica) or previous intolerance to gabapentin or pregabalin
* Daily use of narcotics for ≥ 2 months
* Acute or chronic renal failure based on past medical history (PMH) or glomerular filtration rate (GFR) \< 30ml/min (see meds info below)
* Severe uncontrolled depression or bipolar disease based on PMH
* Fall risk if history of fall in last year or current use of cane/walker
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03123861
Study Brief:
Protocol Section:
NCT03123861