Vaginal Orthosis Use After Vaginal Reconstructive Surgery

NCT05812859 | Active Not Recruiting FDA Device

• 1 other identifier: IRB-300010943
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Objective recurrent anterior prolapse

  Pelvic exam will be performed at 12 months post-operative visit and POP-Q measurements will be performed. The "Ba" measurement will be used as the primary outcome comparing the measurements of the vaginal orthosis group and the standard of care group.

  12 months.

Secondary Outcomes (3)

• Subjective recurrent prolapse

  12 months

• Objective recurrent prolapse

  3, 6, and 12 months

• Device use complications

  12 months

Study Arms (2)

Device Use

EXPERIMENTAL

Patient's will use vaginal orthosis daily from the start of week 2 post-operative to week 12 post-operative.

Device: Vaginal Orthosis (COSM Medical)

Standard of Care

NO INTERVENTION

Patient's will proceed with normal standard of care post-operative management which is pelvic rest and light acitvity.

Interventions

Vaginal Orthosis (COSM Medical) DEVICE

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.

Device Use

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

UAB Hospital

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Examiner in the post-operative setting will be blinded to intervention during examination and survey.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Instructor Fellow

Study Record Dates

• First Submitted: March 31, 2023
• First Posted: April 14, 2023
• Study Start: January 29, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)