Vaginal Diazepam for the Treatment of Female Pelvic Pain

Intravaginal Diazepam for the Treatment of Pelvic Pain Among Women With Pelvic Floor Hypertonic Disorder: a Double Blind, Randomized, Placebo Controlled Trial

To determine the efficacy of intravaginal diazepam for the treatment of pelvic pain associated with pelvic floor hypertonic disorder.

Study Overview

• Status: Completed
• Conditions: Pelvic Pain; Pelvic Floor Disorders
• Intervention / Treatment: Drug: Placebo; Drug: Diazepam

Detailed Description

Women who are asked to participate will already be receiving a standard conservative therapy consisting of a psyllium-based bowel regimen, heat therapy, pelvic stretching exercises, and Kegel exercises. Participants will randomly be assigned by a computer-derived random number sequence (after pregnancy is ruled out) to either the treatment group (intravaginal diazepam) or the placebo group Investigators and patients will be blinded to group assignment. The placebo or diazepam tablet will be distributed to the participant in the examining room on the day of allocation. The participant will be instructed to insert the diazepam or placebo tablet into her vagina at home. The treatment group will insert the diazepam 10 mg vaginal tablet 1-2 times daily as needed in addition to the standard conservative therapy. The placebo group will receive the standard conservative therapy, and an intravaginal tablet (visually indistinguishable from diazepam) commercially produced by the university pharmacy. After 4 weeks, patients from either group will have the option of enrolling into a standard routine program (not research) of comprehensive pelvic floor rehabilitation therapy. The Visual Analog Pain Scale, Pelvic Floor Distress Inventory-20 Questionnaire, McGill Pain Questionnaire and Global Response Assessment will be completed by the participant at the initial visit, 4 weeks, 8 weeks and 12 weeks. Participants will be given the option of choosing one or more methods for returning questionnaires: electronic mail, self-addressed home envelope, or telephone call.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Columbia, Missouri, United States, 65201
      • Missouri Center for Female Continence and Advanced Pelvic Surgery, University of Missouri Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Diazepam; Participated will be instructed to insert one 10mg tablet vaginally 1-2 times per day as needed for pain.	Drug: Diazepam; Other Names: Valium
Placebo Comparator: Placebo; Participated will be instructed to insert one 10mg tablet vaginally 1-2 times per day as needed for pain.	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale (VAS) for Pain	Ten centimeter (100 mm) linear pain scale where patients mark their self-perceived level of pain on a paper with a 10 cm line indicating that the 0 cm position indicates no pain and the 10 cm position indicates the worst pain imaginable. The score is measured as the distance between the zero position and the patient's mark is measured in cm to the nearest mm. A higher score indicates a worse outcome. The change in pain score is calculated by from the value at baseline minus the value at 4 weeks. Potential range is -100 to 100, with a higher value indicating a better outcome.	Baseline and 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pelvic Floor Distress Inventory-20 (PFDI-20) Questionnaire Score at 4 Weeks.	The Pelvic Floor Distress Inventory-20 is both a symptom inventory and a measure of the degree of bother and distress (quality-of-life) caused by pelvic floor symptoms. Includes 20 questions and 3 scales. Each of the 3 scales is scored from a minimum score of 0 (least distress) to a maximum of 100 (greatest distress), thus a higher score indicates a poorer outcome. The scores from each of the 3 scales are added together to give a summary score (range 0 to 300). The PFDI-20 questionnaire was administered at baseline and at 4 weeks of treatment. The outcome was the score at 4 weeks of treatment.	4 weeks
McGill Pain Questionnaire Score (PRI) at 4 Weeks	The McGilll pain questionnaire is a validated instrument that assigns quantitative value to qualitative descriptions of chosen by the patient. The minimum pain score is 0 (would not be seen in a person with true pain) and the maximum pain score: 78. The higher the pain score the greater the pain and the poorer the outcome. measured at 4 weeks.	4 weeks

Collaborators and Investigators

• Sponsor: Raymond Foster
• Investigators: Principal Investigator: Raymond T Foster, MD, University of Missouri-Columbia

Publications and helpful links

General Publications

• Holland MA, Joyce JS, Brennaman LM, Drobnis EZ, Starr JA, Foster RT Sr. Intravaginal Diazepam for the Treatment of Pelvic Floor Hypertonic Disorder: A Double-Blind, Randomized, Placebo-Controlled Trial. Female Pelvic Med Reconstr Surg. 2019 Jan/Feb;25(1):76-81. doi: 10.1097/SPV.0000000000000514.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2013
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: August 30, 2013
• First Submitted That Met QC Criteria: September 4, 2013
• First Posted (Estimated): September 10, 2013

Study Record Updates

• Last Update Posted (Actual): September 3, 2024
• Last Update Submitted That Met QC Criteria: August 29, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Pelvic pain; Female; Randomized trial; High-tone pelvic floor dysfunction; Spasm; Diazepam
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pregnancy Complications; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pelvic Floor Disorders; Pelvic Pain; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Antiemetics; Gastrointestinal Agents; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Anticonvulsants; Neuromuscular Agents; Muscle Relaxants, Central; Diazepam
• Other Study ID Numbers: 1208827

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No