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Vaginal Diazepam for the Treatment of Female Pelvic Pain

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01938092
First Posted: September 10, 2013
Last Update Posted: July 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Raymond Foster, University of Missouri-Columbia
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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 Raymond Foster, 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: Initial visit, 4 weeks, 12 weeks, 24 weeks ]
    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 ]
    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. ]
    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 ]
    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.


Enrollment: 50
Actual Study Start Date: September 2013
Study Completion Date: July 2017
Primary Completion Date: March 2017 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01938092


Locations
United States, Missouri
Missouri Center for Female Continence and Advanced Pelvic Surgery, University of Missouri Health System
Columbia, Missouri, United States, 65201
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
Principal Investigator: Raymond T Foster, MD University of Missouri-Columbia
  More Information

Responsible Party: Raymond Foster, Principal Investigator, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT01938092     History of Changes
Other Study ID Numbers: 1208827
First Submitted: August 30, 2013
First Posted: September 10, 2013
Last Update Posted: July 26, 2017
Last Verified: July 2017

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

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