Using perineal massage to improve comfort during pessary examinations
Perineal Massage for Increased Comfort During Pessary Examinations: a Cross-over Randomized Controlled Trial
This study tests if using perineal massage can make women more comfortable during pessary exams for vaginal prolapse and urinary incontinence.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 68 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of North Carolina, Chapel Hill Academic / other |
| Locations | 1 site (Raleigh, North Carolina) |
| Trial ID | NCT06416982 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of perineal massage as a technique to enhance comfort during pessary examinations for women experiencing vaginal prolapse and stress urinary incontinence. Pessaries are non-surgical devices that can help manage these conditions, but discomfort during their insertion and removal can limit their use. By applying perineal massage, the study aims to reduce discomfort associated with these procedures, potentially allowing more women to benefit from pessary management. Participants will learn and practice this technique prior to their pessary examinations.
Who should consider this trial
Good fit: Ideal candidates are women undergoing routine pessary management who can provide informed consent and follow up for two consecutive examinations.
Not a fit: Patients with significant vaginal erosion, cognitive or functional impairments, or those who regularly use pain medications for pessary checks may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the comfort and experience of women undergoing pessary management.
How similar studies have performed: While the use of perineal massage in this context is novel, similar techniques have shown promise in reducing discomfort during other gynecological procedures.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Raleigh, North Carolina
- UNC Urogynecology — Raleigh, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Christine Chu, MD, MSCI — University of North Carollina at Chapel Hill
- Study coordinator: Christine Chu, MD, MSCI
- Email: christine_chu@med.unc.edu
- Phone: 9849740496
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.