Perineal Massage for Pessary Examinations

NCT ID: NCT06416982

Last Updated: 2024-08-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2025-08-31

Brief 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 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.

Conditions

Prolapse, Vaginal; Stress Urinary Incontinence; Pessaries; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Perineal massage before pessary examination

Participant will undergo 2 minutes of perineal massage with water-based gel prior to the pessary examination.

This consists of 2 minutes of perineal massage at 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. The massage will be done by trained doctors who are not performing the pessary check.

Group Type: EXPERIMENTAL

Perineal massage

Intervention Type: OTHER

2 minutes of perineal massage as described in arm/group descriptions.

No perineal massage before pessary examination

Participant will not undergo 2 minutes of perineal massage, but will have water-based gel applied to the vaginal introitus and perineum prior to the pessary check.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Perineal massage

2 minutes of perineal massage as described in arm/group descriptions.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christine Chu, MD, MSCI

Role: PRINCIPAL_INVESTIGATOR

University of North Carollina at Chapel Hill

Locations

UNC Urogynecology

Raleigh, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Christine Chu, MD, MSCI

Role: CONTACT

christine_chu@med.unc.edu

9849740496

Rodney Stephenson

Role: CONTACT

rodney_stephenson@med.unc.edu

919-966-4717

Facility Contacts

Jennifer Antonios

Role: primary

984-974-0496

Other Identifiers

24-0544

Identifier Type: -

Identifier Source: org_study_id