Vaginal Diazepam for the Treatment of Female Pelvic Pain

NCT01938092 | Completed Phase 2 Results

• 1 other identifier: 1208827
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pelvic Floor Disorders; Pelvic Pain

Keywords

High-tone pelvic floor dysfunction; Spasm; Pelvic pain; Diazepam; Female; Randomized trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Pelvic Floor Distress Inventory-20 (PFDI-20) Questionnaire Score at 4 Weeks.

  4 weeks

• McGill Pain Questionnaire Score (PRI) at 4 Weeks

  4 weeks

Study Arms (2)

Diazepam

ACTIVE COMPARATOR

Participated will be instructed to insert one 10mg tablet vaginally 1-2 times per day as needed for pain.

Drug: Diazepam

Placebo

PLACEBO COMPARATOR

Participated will be instructed to insert one 10mg tablet vaginally 1-2 times per day as needed for pain.

Drug: Placebo

Interventions

Diazepam DRUG

Also known as: Valium

Diazepam

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Raymond Foster: lead

Study Sites (1)

Missouri Center for Female Continence and Advanced Pelvic Surgery, University of Missouri Health System

Columbia, Missouri, 65201, United States

Location

Related Publications (1)

• 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.

  PMID: 29280763 DERIVED

MeSH Terms

Conditions

Pelvic Floor Disorders; Pelvic Pain; Spasm

Interventions

Diazepam

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neuromuscular Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

1. 92% of participants Caucasian; results may differ in diverse populations 2. participants in placebo group more likely to use vaginal estrogen 3. Powered to detect a 20% difference if present; underpowered to detect a smaller difference.

Results Point of Contact

• Title: Erma Z. Drobnis, Associate Director, Research Success Center
• Organization: University of Missouri-Columibia, Dept. Ob/Gyn

drobnise@health.missouri.edu

573-817-3124

Study Officials

• Raymond T Foster, MD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 30, 2013
• First Posted: September 10, 2013
• Study Start: September 1, 2013
• Primary Completion: March 1, 2017
• Study Completion: July 1, 2017
• Last Updated: September 3, 2024
• Results First Posted: September 3, 2024

Record last verified: 2024-08

Locations

US (1)