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 @ 3:02 AM
Ignite Modification Date:
2025-12-25 @ 3:02 AM
NCT ID:
NCT04198233
Eligibility Criteria:
Inclusion Criteria:
* English speaking, able to understand informed consent and questionnaires
* Vaginal hysterectomy with vaginal vault suspension by one of the providers in the Division of Urogynecology and Reconstructive Pelvic Surgery at TriHealth, Inc.
* With or without anterior and posterior repairs
* With or without concomitant procedure for stress urinary incontinence
* With or without removal of fallopian tubes or ovaries
Exclusion Criteria:
* Use of mesh for prolapse repair
* Robotic, laparoscopic, or open technique used for prolapse repair and/or hysterectomy
* Concomitant procedure done by an additional surgeon
* Concomitant anal sphincteroplasty or rectovaginal fistula repair
* Contraindication to use of Diazepam:
* Allergy to Diazepam or other benzodiazepines
* Acute narrow-angle glaucoma
* Untreated open-angle glaucoma
* Myasthenia gravis
* Severe respiratory impairment
* Severe hepatic impairment
* History of chronic pelvic pain receiving medical care
* Daily use of medication for pain: NSAID, Tylenol, opioid, gabapentin, and/or amitriptyline
* Pregnancy
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04198233
Study Brief:
Protocol Section:
NCT04198233