Perineal Massage for Pessary Examinations

NCT06416982 | Active Not Recruiting

• 1 other identifier: 24-0544
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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

Pessaries; Pain; Stress Urinary Incontinence; Prolapse, Vaginal

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Patient-perceived pain

  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.

  3 months

Secondary Outcomes (5)

• Patient satisfaction with perineal massage

  3 months

• Patient preference for future perineal massage

  3 months

• Provider-perceived patient discomfort

  3 months

• Provider-perceived ease of pessary removal

  3 months

• Perineal and vaginal abrasion

  3 months

Other Outcomes (1)

• Patient discomfort during perineal massage

  At the 3 month follow up visit

Study Arms (2)

Perineal massage before pessary examination

EXPERIMENTAL

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.

Other: Perineal massage

No perineal massage before pessary examination

NO INTERVENTION

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.

Interventions

Perineal massage OTHER

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

Perineal massage before pessary examination

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

UNC Urogynecology

Raleigh, North Carolina, 27607, United States

Location

MeSH Terms

Conditions

Uterine Prolapse; Urinary Incontinence, Stress; Pain

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pelvic Organ Prolapse; Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Urinary Incontinence; Urination Disorders; Urologic Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Neurologic Manifestations

Study Officials

• Christine Chu, MD, MSCI

  University of North Carollina at Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: Participants will be randomized to intervention vs no intervention at the first visit without stratification, then will undergo the opposite intervention at the second visit. While participants cannot be blinded to the intervention, providers performing the pessary checks and providing provider-perceived pain scores will be blinded to the intervention as someone on the research team other than the provider will perform the intervention prior to the pessary check. If there is unexpected breaking of the blind (e.g. participant tells provider which intervention was performed), the provider will report this to the research team and this will be noted in the study results.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: May 16, 2024
• Study Start: August 1, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)