Active — Not RecruitingNot Applicable

Vaginal Orthosis Use After Vaginal Reconstructive Surgery

United States30 participantsStarted 2024-01-29

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

Objective recurrent anterior prolapse

Timeframe: 12 months.

Trial details

NCT IDNCT05812859

SponsorUniversity of Alabama at Birmingham

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06

View on ClinicalTrials.gov More Pelvic Organ Prolapse trials