Clinical trial NCT06416982: Perineal Massage for Pessary Examinations
Official title: Perineal Massage for Increased Comfort During Pessary Examinations: a Cross-over Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prolapse, Vaginal
Stress Urinary Incontinence
Pessaries
Pain
Keywords: Pessaries
Vaginal prolapse
Stress urinary incontinence
Pain
Conservative management
Perineal massage
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Patient-perceived pain
timeFrame: 3 months
Secondary outcomes:
measure: Patient satisfaction with perineal massage
timeFrame: 3 months
measure: Patient preference for future perineal massage
timeFrame: 3 months
measure: Provider-perceived patient discomfort
timeFrame: 3 months
measure: Provider-perceived ease of pessary removal
timeFrame: 3 months
measure: Perineal and vaginal abrasion
timeFrame: 3 months
Other outcomes:
measure: Patient discomfort during perineal massage
timeFrame: At the 3 month follow up visit
Locations:
city: Raleigh
country: United States
facility: UNC Urogynecology
state: North Carolina
Study officials:
affiliation: University of North Carollina at Chapel Hill
name: Christine Chu, MD, MSCI
role: PRINCIPAL_INVESTIGATOR
References: