Baclofen/Diazepam Supps for Treatment of Pelvic Floor Myalgia

• Status: Unknown status
• Trial end date: 2018-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

This study is a randomized, placebo controlled double blind cross over trial. Patients presenting with pelvic floor myalgia will be asked to complete a series of standardized questionnaires to assess their pain, quality of life and sexual function and satisfaction. They will be randomized to either a treatment group or placebo group and will use the supplied suppositories once daily for 2 months. They will then undergo a one month "washout" after which they will be placed in the cross over group for a second two months of treatment.

Primary outcome measure: change in Visual Analogue Scale for Pain (VAS-P) scores before and after treatment Secondary outcome measures: change in Female Sexual Function Index (FSFI), Patient Global Impression of Improvement (PGI-I), and Short Form Health Survey (SF-12) before and after treatment

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Dr. John A. Thiel Medical Professional Corporation
• Treatments: Baclofen; Diazepam

Criteria

Inclusion Criteria:

• Patients with significant pelvic floor dyssynergia and pain during sexual activity.

Exclusion Criteria:

• Decide you do not wish to participate

• Are pregnant

• Have active pelvic inflammatory disease

• Have an active sexually transmitted infection (STI)

• Have a known or suspected cancer of the genital tract

• Have untreated or unevaluated changes in your Pap smear

• Are not currently sexually active

• Have an allergy to either baclofen or valium

• Are unable to complete the necessary study questionnaires