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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 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.
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
Conditions Studied
Interventions
- OTHER Perineal massage
Study Locations (1)
North Carolina
- UNC Urogynecology - Raleigh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2024-08-01 |
| Est. Completion | 2026-04-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06416982
The ClinicalTrials.gov registry entry for NCT06416982 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 68 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 304-participant average among 374 other Pain trials with a reported enrollment target (78% lower). The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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