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Cross-Shaped device aims to ease pelvic organ prolapse

NCT ID NCT07554651

Disease control Sponsor: Dnipro State Medical University 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new, cross-shaped silicone pessary for women with pelvic organ prolapse. 51 women who already used a traditional pessary tried the new device for 6 months. Researchers measured symptom distress and how many women kept using it. The goal was to see if the new shape works better or is more comfortable than standard pessaries.

What this could mean

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

Active substance
volumetric cross-shaped vaginal pessary (a silicone device)
What this could lead to
If it works well, this new pessary could offer women with pelvic organ prolapse a more comfortable and effective option than traditional pessaries.
What could go wrong
This is a small, single-arm study with only 51 participants, so results may not apply to everyone. The device may not be better than existing options and could cause discomfort or other issues.

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

51 people

The number who actually took part.

Started

Sep 2024

Finished

Jun 2025

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

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Female participants aged 18 years or older * Pelvic organ prolapse stage II or higher in any compartment * Current use of a traditional vaginal pessary for at least 12 consecutive weeks before enrollment * Willing and able to provide written informed consent * Able to attend scheduled follow-up visits or participate in telephone interviews Exclusion Criteria: * Active vaginal or pelvic infection at enrollment * Pregnancy or planned pregnancy during the study period * History of pelvic radiation therapy * Severe vaginal atrophy with active erosion preventing pessary use * Planned surgical treatment for pelvic organ prolapse during the study period * Cognitive impairment or psychiatric condition precluding informed consent or protocol compliance * Known allergy to silicone

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Conditions

The condition(s) this trial relates to.

Pelvic Floor Disorders pelvic organ prolapse pelvic organ prolapse, susceptibility to Uterine Prolapse

As listed by the trial registrant

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

Pelvic organ prolapse Pelvic organ prolapse (POP) Vaginal prolapse

Contacts and locations

Locations

  • City Clinical Hospital No. 6, Dnipro City Council

    Dnipro, Ukraine

  • City Out-Patient Clinic No. 18, Kharkiv City Council

    Kharkiv, Ukraine

  • Clinical Hospital of Emergency Medical Care, Dnipro City Council

    Dnipro, Ukraine

  • Regional Clinical Hospital, Poltava Regional Council

    Poltava, Ukraine

  • State Interdistrict Screening Center

    Sheptytskyi, Ukraine

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