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Vaginal Orthosis Use After Vaginal Reconstructive Surgery

NCT05812859 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-06-26

No results posted yet for this study

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.

Conditions

  • Pelvic Organ Prolapse

Interventions

DEVICE

Vaginal Orthosis (COSM Medical)

A vaginal orthosis will be 3-D printed by COSM Medical and provided for patients to use from week 2 through week 12 post-operatively. Device will be placed in morning and removed before bed daily.

Sponsors & Collaborators

  • University of Alabama at Birmingham

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-29
Primary Completion
2026-06-30
Completion
2026-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05812859 on ClinicalTrials.gov