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Massage may ease pain during pessary checks, new study says

NCT ID NCT06416982

Symptom relief Sponsor: University of North Carolina, Chapel Hill 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a 2-minute perineal massage before a pessary exam can reduce pain and discomfort. 68 women with prolapse or incontinence will try both massage and a gel-only method at separate visits. The goal is to find a simple, non-drug way to improve comfort during routine care.

What this could mean

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

Active substance
perineal massage
What this could lead to
If effective, perineal massage could offer a simple, drug-free way to make pessary exams more comfortable for women.
What could go wrong
This is a small, early-stage trial with only 68 participants, so results may not apply to everyone. The benefit may be small or not noticeable.

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 68 people

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

Started

Aug 2024

Expected to finish

Apr 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

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: * Undergoing routine pessary management by office providers * Able to provide informed consent (as reported by patient or family member) * Able to follow up with the UNC Urogynecology office for two consecutive pessary examination Exclusion Criteria: * Non-English speaking * Found to have a condition such as significant vaginal erosion that precludes replacement of pessary after exam * Unable to undergo massage due to functional or cognitive impediments or significant discomfort during massage * Regular usage of pain medications for prior pessary checks such as lidocaine, and unwilling to forgo lidocaine for two study visits * Pessary visit for pain, pessary expulsion, or significant bleeding, as per provider's judgement

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Conditions

The condition(s) this trial relates to.

female stress incontinence Pain pelvic organ prolapse Urinary Incontinence, Stress Uterine Prolapse

As listed by the trial registrant

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

Pain Pessaries Prolapse, vaginal Stress urinary incontinence

Contacts and locations

Locations

  • UNC Urogynecology

    Raleigh, North Carolina, 27607, United States

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