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Behavioural Intervention

Perineal Massage for Prolapse

N/A

Recruiting

Led By Christine Chu, MD, MSCI

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Non-English speaking

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test if massaging the perineum before a pessary check can help make the procedure more comfortable for patients. Pessaries are devices used to treat prolapse, but

Who is the study for?

This trial is for women who use pessaries to manage conditions like urinary incontinence and uterine prolapse. Participants should be following up with the Urogynecology division at UNC for pessary checks. The study excludes specific details on eligibility criteria, but typically those with allergies or conditions that could interfere with the treatment may not qualify.

What is being tested?

The trial tests if perineal massage before a pessary check can make it more comfortable. Women will either receive a perineal massage or just have gel applied without massage before their pessary examination, and then switch methods on their next visit.

What are the potential side effects?

Potential side effects from this intervention might include discomfort during the massage, possible laceration or abrasion of perineal tissue, although these are generally considered low-risk procedures.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not speak English.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Patient-perceived pain

Secondary study objectives

Patient preference for future perineal massage

Patient satisfaction with perineal massage

Perineal and vaginal abrasion

+2 more

Other study objectives

Patient discomfort during perineal massage

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Perineal massage before pessary examinationExperimental Treatment1 Intervention

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 II: No perineal massage before pessary examinationActive Control1 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.

0 / 1Eligibility criteria met