Vaginal Diazepam for the Treatment of Female Pelvic Pain

Phase 2

Completed

• Conditions: Pelvic Floor Disorders; Pelvic Pain

• Registration Number: NCT01938092
• Lead Sponsor: Raymond Foster

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-8-30
• Last Update Posted: 23 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

Inclusion Criteria:<br><br> - Age 18 years old<br><br> - Primary complaint of acute or chronic pelvic pain with or without dyspareunia<br><br> - Physical exam findings consistent with levator muscle spasm<br><br> - Capable of inserting tablet in vagina without use of applicator.<br><br>Exclusion Criteria:<br><br> - Chronic narcotic use<br><br> - Non-English speaking<br><br> - Currently serving a prison sentence<br><br> - Stage III or greater vaginal prolapse<br><br> - Allergies or contraindications to benzodiazepines<br><br> - Pregnant or breastfeeding<br><br> - Currently receiving comprehensive pelvic floor rehabilitation therapy and/or vaginal<br> valium therapy<br><br> - Unwilling or incapable of inserting tablet in vagina without applicator.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS) for Pain

Secondary Outcome Measures

Name	Time	Method
Pelvic Floor Distress Inventory-20 (PFDI-20) Questionnaire Score at 4 Weeks.;McGill Pain Questionnaire Score (PRI) at 4 Weeks