Vaginal Orthosis Use After Vaginal Reconstructive Surgery

Running, not enrolling · Not applicable

Conditions studied: Pelvic Organ Prolapse

In brief

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.

Key facts

Study ID: NCT05812859
Run by: University of Alabama at Birmingham
People needed: 30
Starts: 2024-01-29
Expected to finish: 2026-09-01
Last updated by the study team: 2026-07-06

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

POP-Q stage 2 to 4 pelvic organ prolapse
Vaginal bulge symptoms as indicated by an affirmative response to either question 4 or 5 of the PFDI:
Do you usually have a sensation of bulging or protrusion from the vaginal area?
Do you usually have a bulge or something falling out that you can see or feel in the vaginal area?
Undergoing reconstructive vaginal surgery for POP-Q stage 2 to 4 pelvic organ prolapse that must include anterior compartment repair and apical suspension.
Willing and able to use and self-manage novel vaginal orthosis after POP surgery from 2 weeks post-operative to 12 weeks post-operative.
Available for 2 and 6 weeks, 3, 6, and 12 months follow-up.
Able to complete study assessments, per clinician judgement.
Able and willing to provide written informed consent.

You may not qualify if…

Contraindication to surgical intervention as planned in the opinion of the treating surgeon (ie undergoing obliterative procedure).
History of previous vaginal reconstructive surgery with or without hysterectomy for POP.
Allergy to silicone used in Novel Vaginal Orthosis.
Allergy or contraindication to low-dose vaginal estrogen use.

Where it is running

UAB Hospital — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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