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NCT06416982 · ClinicalTrials.gov registry record · NA

Perineal Massage for Pessary Examinations

A NA study of Pain and Stress Urinary Incontinence, sponsored by University of North Carolina, Chapel Hill.

Active
Registry status
NA
Development phase
68
Enrollment target
1
Study location

NCT06416982: Active NA study of Pain and Stress Urinary Incontinence, sponsored by University of North Carolina, Chapel Hill.

NCT06416982 is a NA study of Pain and Stress Urinary Incontinence that is active but no longer recruiting, run by University of North Carolina, Chapel Hill. The registered enrollment target is 68 participants, below the 304-participant average among 374 other Pain trials with a reported enrollment target (78% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06416982, a NA study of Pain and Stress Urinary Incontinence, is active but no longer recruiting, sponsored by University of North Carolina, Chapel Hill.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
68 participants
Enrollment target
1
Study location

Study Summary

Pessaries are effective non-surgical devices for reduction of prolapse. However, use of pessaries are limited in some women due to patient discomfort. While lidocaine can be used to improve pessary checks, its use may be limited due to supply chain shortages, lack of insurance coverage, and optimization of resource utilization. More techniques to improve pessary examination comfort are needed. Perineal massage prior to delivery and at the time of active labor has been noted to reduce perineal trauma and perineal discomfort, theoretically by desensitizing the nerve endings in the skin, broadening the vaginal opening, and increasing elasticity of the perineal tissue. Since most discomfort with pessary checks is during removal and insertion through the vaginal introitus, perineal massage may be a beneficial technique that women could potentially learn to improve comfort with pessary checks. The objective of this study is to examine the effectiveness of perineal massage prior to pessary check in improving comfort of pessary checks for patients using a cross-over randomized controlled trial. Patients who follow up for pessary checks with the division of Urogynecology at UNC will be approached about participating in this study. The study will involve two clinical visits. At the first visit, the patient will be randomized to 2 minutes of perineal massage with water based gel of the external perineum and sides of the vaginal vestibule, as well as internal massage with the thumb, gliding from 4 to 8 o'clock, then tissue stretching technique with one intracavitary finger and other external finger at the 4 o'clock and 8 o'clock positions three times; versus application of gel to the internal vagina and external vagina without massage. Providers will be blinded to randomization and proceed with pessary check as per normal clinical protocols. Patients will rate self-reported pain before, during pessary check, and after the pessary check on a VAS scale; and rate whether they w

Primary Outcome

Change in pain scores during pessary check (removal and replacement) compared to baseline pain score prior to pessary check using a visual analog scale (VAS) pain scale, as reported by the participant. The VAS pain scale is a validated scale that is performed by having the participant place a mark on a 10 cm line from 0 to 10 to indicate severity of pain. 0 indicates no pain, 10 indicates the most severe pain. Distance from 0 to the mark is measured and recorded in millimeters.

Interventions

  • OTHER Perineal massage

Study Locations (1)

North Carolina

  • UNC Urogynecology - Raleigh

Trial Details

FieldValue
Enrollment Target 68 participants
Start Date 2024-08-01
Est. Completion 2026-04-01
Phase NA

What the registry record for NCT06416982 still lists

NCT06416982 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, below the 304-participant average among 374 other Pain trials with a reported enrollment target (78% lower).

The record links to 4 conditions, with Pain appearing as the primary indexed condition, and to 1 intervention - of which Perineal massage is the first listed.

NCT06416982 reports a single indexed study location in North Carolina.

Frequently Asked Questions

What is clinical trial NCT06416982 about?

NCT06416982 is a clinical study titled "Perineal Massage for Pessary Examinations". Pessaries are effective non-surgical devices for reduction of prolapse. However, use of pessaries are limited in some women due to patient discomfort. While lidocaine can be used to improve pessary checks, its use may be limited due to supply chain shortages, lack of insurance coverage, and optimiza...

What is the current status of trial NCT06416982?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 68 participants. The study started on 2024-08-01. Estimated completion is 2026-04-01.

What conditions does trial NCT06416982 study?

This clinical trial studies the following conditions: Pain, Stress Urinary Incontinence, Prolapse, Vaginal, Pessaries.

What interventions are being tested in trial NCT06416982?

The interventions under investigation include: Perineal massage (OTHER).

Who is sponsoring clinical trial NCT06416982?

This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06416982 being conducted?

This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Pain

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06416982's enrollment target sits among peer trials

68 217th of 374 higher than 155 of 374 other Pain trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06416982, the US trial registry maintained by the National Library of Medicine. NCT06416982 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.