Perineal Massage for Pessary Examinations

Not Applicable

Recruiting

• Conditions: Prolapse, Vaginal; Stress Urinary Incontinence; Pessaries; Pain

• Registration Number: NCT06416982
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-5-13
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> - Undergoing routine pessary management by office providers<br><br> - Able to provide informed consent (as reported by patient or family member)<br><br> - Able to follow up with the UNC Urogynecology office for two consecutive pessary<br> examination<br><br>Exclusion Criteria:<br><br> - Non-English speaking<br><br> - Found to have a condition such as significant vaginal erosion that precludes<br> replacement of pessary after exam<br><br> - Unable to undergo massage due to functional or cognitive impediments or significant<br> discomfort during massage<br><br> - Regular usage of pain medications for prior pessary checks such as lidocaine, and<br> unwilling to forgo lidocaine for two study visits<br><br> - Pessary visit for pain, pessary expulsion, or significant bleeding, as per<br> provider's judgement

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient-perceived pain

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction with perineal massage;Patient preference for future perineal massage;Provider-perceived patient discomfort;Provider-perceived ease of pessary removal;Perineal and vaginal abrasion