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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
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 moreOther 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.
Find a Location
Who is running the clinical trial?
University of North Carolina, Chapel HillLead Sponsor
1,569 Previous Clinical Trials
4,319,516 Total Patients Enrolled
Christine Chu, MD, MSCIPrincipal InvestigatorUniversity of North Carollina at Chapel Hill