Vaginal Diazepam for the Treatment of Female Pelvic Pain

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by University of Missouri-Columbia
Sponsor:
Information provided by (Responsible Party):
Raymond Foster, University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT01938092
First received: August 30, 2013
Last updated: October 22, 2013
Last verified: October 2013
  Purpose

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


Condition Intervention Phase
Pelvic Floor Disorders
Pelvic Pain
Drug: Diazepam
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Intravaginal Diazepam for the Treatment of Pelvic Pain Among Women With Pelvic Floor Hypertonic Disorder: a Double Blind, Randomized, Placebo Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Missouri-Columbia:

Primary Outcome Measures:
  • Change from baseline in Visual Analog Pain Scale score at 4 weeks, 12 weeks, and 24 weeks. [ Time Frame: Inital visit, 4 weeks, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
    Ten centimeter linear scale where patients mark their self-perceived level of pain. The change in pain from the initial visit will be measured at 4 weeks, 12 weeks, and 24 weeks.


Secondary Outcome Measures:
  • Change from baseline in Pelvic Floor Distress Inventory-20 Questionnaire score at 4 weeks, 12 weeks, and 24 weeks. [ Time Frame: Initial visit, 4 weeks, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
    The PFDI-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 0 (least distress) to 100 (greatest distress). The change in PFDI-20 score from the initial visit will be measured at 4 weeks, 12 weeks, and 24 weeks.

  • Change from baseline in McGill Pain Questionnaire score at 4 weeks, 12 weeks, and 24 weeks. [ Time Frame: Initial visit, 4 weeks, 12 weeks, 24 weeks. ] [ Designated as safety issue: No ]
    Used to evaluate a person experiencing significant pain. It can be used to monitor the pain over time and to determine the effectiveness of any intervention. It asks the participant what the pain feels like, how it changes with time, and how strong it is. The change in symptoms from baseline measured by this questionnaire will be measured at 4 weeks, 12 weeks ,and 24 weeks.

  • Change from baseline in Global Response Assessment score at 4 weeks, 12 weeks, and 24 weeks. [ Time Frame: Initial visit, 4 weeks, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
    Used to evaluate patients' perceptions of treatment effectiveness. The change in the GRA from from the initial visit will be measured at 4 weeks, 12 weeks, and 24 weeks.


Estimated Enrollment: 50
Study Start Date: September 2013
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01938092

Contacts
Contact: Raymond Foster, MD 573-817-3165 FosterRT@health.missouri.edu
Contact: Michael Holland, DO 573-882-8885 hollandma@health.missouri.edu

Locations
United States, Missouri
Missouri Center for Female Continence and Advanced Pelvic Surgery, University of Missouri Health System Recruiting
Columbia, Missouri, United States, 65201
Contact: Raymond T Foster, MD    573-817-3165    FosterRT@health.missouri.edu   
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
Principal Investigator: Raymond T Foster, MD University of Missouri-Columbia
  More Information

No publications provided

Responsible Party: Raymond Foster, Principal Investigator, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT01938092     History of Changes
Other Study ID Numbers: 1208827
Study First Received: August 30, 2013
Last Updated: October 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Missouri-Columbia:
High-tone pelvic floor dysfunction
Spasm
Pelvic pain
Diazepam
Female
Randomized trial

Additional relevant MeSH terms:
Pelvic Floor Disorders
Disease
Pelvic Pain
Pain
Pathologic Processes
Pregnancy Complications
Signs and Symptoms
Diazepam
Adjuvants, Anesthesia
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Anti-Anxiety Agents
Anticonvulsants
Antiemetics
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
GABA Agents
GABA Modulators
Gastrointestinal Agents
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Muscle Relaxants, Central
Neuromuscular Agents
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs

ClinicalTrials.gov processed this record on October 23, 2014