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Completed NCT05812859

Vaginal Orthosis Use After Vaginal Reconstructive Surgery

Conditions: Pelvic Organ Prolapse

Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 30
Sponsor: University of Alabama at Birmingham

Location: UAB Hospital Birmingham Alabama

Summary

A novel vaginal orthosis, or splint, made of silicone will be used daily to help support the healing vaginal reconstruction during the post-operative phase from week 2 to week 12.

Eligibility Criteria

Inclusion Criteria: 1. POP-Q stage 2 to 4 pelvic organ prolapse 2. Vaginal bulge symptoms as indicated by an affirmative response to either question 4 or 5 of the PFDI: 1. Do you usually have a sensation of bulging or protrusion from the vaginal area? 2. Do you usually have a bulge or something falling out that you can see or feel in the vaginal area? 3. Undergoing reconstructive vaginal surgery for POP-Q stage 2 to 4 pelvic organ prolapse that must include anterior compartment repair and apical suspension. 4. Willing and able to use and self-manage novel vaginal orthosis after POP surgery from 2 weeks post-operative to 12 weeks post-operative. 5. Available for 2 and 6 weeks, 3, 6, and 12 months follow-up. 6. Able to complete study assessments, per clinician judgement. 7. Able and willing to provide written informed consent. Exclusion Criteria: 1. Contraindication to surgical intervention as planned in the opinion of the treating surgeon (ie undergoing obliterative procedure). 2. History of previous vaginal reconstructive surgery with or without hysterectomy for POP. 3. Allergy to silicone used in Novel Vaginal Orthosis. 4. Allergy or contraindication to low-dose vaginal estrogen use.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05812859). StuddyBuddy aggregates publicly available trial information.