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Silicone splint aims to prevent prolapse from returning after surgery

NCT ID NCT05812859

Disease control Sponsor: University of Alabama at Birmingham Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time

Summary

This study tests a custom silicone vaginal splint used daily for 10 weeks after reconstructive surgery for pelvic organ prolapse. The device is placed in the morning and removed at night to support healing. Researchers will compare prolapse recurrence rates and symptoms between women who use the splint and those who receive standard care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Vaginal orthosis (silicone splint)
What this could lead to
If it works, this device could improve healing and lower the chance of prolapse returning after surgery.
What could go wrong
This is a small early study with only 30 participants, so results may not apply widely. The device may be uncomfortable or not reduce recurrence as hoped.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2024

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

pelvic organ prolapse

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pelvic organ prolapse

Contacts and locations

Locations

  • UAB Hospital

    Birmingham, Alabama, 35294, United States

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