RECRUITING

Perineal Massage for Pessary Examinations

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 would prefer to repeat this method at future visits via Likert scale. Healthcare professionals will also rate perceived patient pain on VAS scale; ease of pessary removal; and note any perineal or introital laceration or abrasion that may occur during the pessary fitting. At the following visit, patients will be assigned to the group to which they were not initially randomized. Patients and healthcare professionals will again rate pain as described above. Patients will also rank preference for perineal massage using PGI-I.

Official Title

Perineal Massage for Increased Comfort During Pessary Examinations: a Cross-over Randomized Controlled Trial

Quick Facts

Study Start:2024-08-01
Study Completion:2025-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06416982

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Undergoing routine pessary management by office providers
  2. * Able to provide informed consent (as reported by patient or family member)
  3. * Able to follow up with the UNC Urogynecology office for two consecutive pessary examination
  1. * Non-English speaking
  2. * Found to have a condition such as significant vaginal erosion that precludes replacement of pessary after exam
  3. * Unable to undergo massage due to functional or cognitive impediments or significant discomfort during massage
  4. * Regular usage of pain medications for prior pessary checks such as lidocaine, and unwilling to forgo lidocaine for two study visits
  5. * Pessary visit for pain, pessary expulsion, or significant bleeding, as per provider's judgement

Contacts and Locations

Study Contact

Christine Chu, MD, MSCI
CONTACT
9849740496
christine_chu@med.unc.edu
Rodney Stephenson
CONTACT
919-966-4717
rodney_stephenson@med.unc.edu

Principal Investigator

Christine Chu, MD, MSCI
PRINCIPAL_INVESTIGATOR
University of North Carollina at Chapel Hill

Study Locations (Sites)

UNC Urogynecology
Raleigh, North Carolina, 27607
United States

Collaborators and Investigators

Sponsor: University of North Carolina, Chapel Hill

  • Christine Chu, MD, MSCI, PRINCIPAL_INVESTIGATOR, University of North Carollina at Chapel Hill

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-01
Study Completion Date2025-08

Study Record Updates

Study Start Date2024-08-01
Study Completion Date2025-08

Terms related to this study

Keywords Provided by Researchers

  • Pessaries
  • Vaginal prolapse
  • Stress urinary incontinence
  • Pain
  • Conservative management
  • Perineal massage

Additional Relevant MeSH Terms

  • Prolapse, Vaginal
  • Stress Urinary Incontinence
  • Pessaries
  • Pain