Pelvic Floor Disorders | Vaginal Diazepam for the Treatment of Female Pelvic Pain
Pelvic Floor Disorders research study
What is the primary objective of this study?
To determine the efficacy of intravaginal diazepam for the treatment of pelvic pain associated with pelvic floor hypertonic disorder.
Who is eligible to participate?
Inclusion Criteria: - Age 18 years old - Primary complaint of acute or chronic pelvic pain with or without dyspareunia - Physical exam findings consistent with levator muscle spasm - Capable of inserting tablet in vagina without use of applicator. Exclusion Criteria: - Chronic narcotic use - Non-English speaking - Currently serving a prison sentence - Stage III or greater vaginal prolapse - Allergies or contraindications to benzodiazepines - Pregnant or breastfeeding - Currently receiving comprehensive pelvic floor rehabilitation therapy and/or vaginal valium therapy - Unwilling or incapable of inserting tablet in vagina without applicator.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Pelvic Floor Disorders
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
DiazepamParticipated will be instructed to insert one 10mg tablet vaginally 1-2 times per day as needed for pain.
PlaceboParticipated will be instructed to insert one 10mg tablet vaginally 1-2 times per day as needed for pain.
Start Date: September 2013
Completed Date: July 2017
Phase: Phase 2
Primary Outcome: Change from baseline in Visual Analog Pain Scale score at 4 weeks, 12 weeks, and 24 weeks.
Secondary Outcome: Change from baseline in Pelvic Floor Distress Inventory-20 Questionnaire score at 4 weeks, 12 weeks, and 24 weeks.
Study sponsors, principal investigator, and references
Principal Investigator: Raymond T Foster, MD
Lead Sponsor: University of Missouri-Columbia