Diazepam Vaginal Suppositories for High Tone Pelvic Floor Dysfunction.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
TriHealth Inc.
ClinicalTrials.gov Identifier:
NCT01233791
First received: November 2, 2010
Last updated: February 20, 2014
Last verified: February 2014
  Purpose

The purpose of this study is to determine whether vaginal diazepam suppositories are an effective treatment of high tone pelvic floor dysfunction.


Condition Intervention
Female Patients With High Tone Pelvic Floor Dysfunction
Drug: Vaginal Diazepam Suppository
Drug: Placebo Suppository

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Diazepam Vaginal Suppositories as a Treatment Option for High Tone PElvic Floor Dysfunction: A Randomized Controlled Trial.

Resource links provided by NLM:


Further study details as provided by TriHealth Inc.:

Primary Outcome Measures:
  • Surface EMG [ Time Frame: After 28 days of treatment ] [ Designated as safety issue: No ]
    A baseline sEMG will be compared to sEMG after 28 days of treatment.


Secondary Outcome Measures:
  • Surface EMG Midpoint [ Time Frame: 14 days after treatment ] [ Designated as safety issue: No ]
    A baseline sEMG will be compared to sEMG after 14 days of treatment.

  • FSFI [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    Baseline FSFI scores will be compared to scores after 4 weeks of treatment to asses sexual function

  • VAS [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Visual analog scale for pain will be collected at baseline and compared to VAS after 28 days of treatment

  • SF-12 [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    baseline SF-12 scores will be compared to SF-12 scores after 28 days of treatment to asses quality of life in the two domains of mental and physical well-being.

  • PGI-I [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Patient Global Impression of Improvement will be asked after 28 days of treatment to determine if the patient felt the treatment was helpful

  • PGI-S [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Patient Global Impression of Severity will be collected and compared to determine how severe teh patient perceived their condition to be before and after treatment


Enrollment: 48
Study Start Date: November 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vaginal Diazepam Suppository
Patients in this arm will be asked to use one vaginal suppository every night for 28 days
Drug: Vaginal Diazepam Suppository
10mg compounded vaginal suppository
Placebo Comparator: Vaginal Placebo Suppository
Patients will be asked to use one vaginal suppository every night for 28 days
Drug: Placebo Suppository
Patients will be asked to use one vaginal suppository every night for 28 days

Detailed Description:

High tone pelvic floor dysfunction is a common cause of pelvic pain in females. It is thought to be initiated by a sentinel event such as trauma, surgery, or vaginal delivery1. Currently, treatment options include warm baths, stretching, physical therapy with myofascial therapy or biofeedback, or pharmacologic therapy with oral amitriptyline or tiazadine2. Physical therapy can be effective. However, it usually involves frequent visits to a specialized physical therapist to undergo intravaginal treatments consisting of myofascial release, massage, or biofeedback. We would like to find a treatment option for patients that would be effective without the invasive and time consuming nature of physical therapy. It is known that diazepam is a valid treatment option for disorders involving spasticity including spastic cerebral palsy5 and tetanus. A literature search on diazepam and high tone pelvic floor dysfunction revealed one paper. This study has an intrinsic flaw as it is a retrospective chart review, and the results are confounded by concurrent physical therapy. They were, however, able to find that patients treated with diazepam suppositories showed a significant improvement in pelvic floor tone. They also assessed pain and sexual function, but these did not reach statistical significance.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • candidates from the Division of Urogynecology at Good Samaritan Hospital in Cincinnati, OH
  • aged 18-65
  • high tone pelvic floor dysfunction

Exclusion Criteria:

  • allergy to diazepam or any drug in the class of benzodiazepines
  • current pelvic floor physical therapy
  • pelvic surgery within the last 3 months
  • current pregnancy, planning on pregnancy during the study period, or not sure if pregnant
  • regular benzodiazepine, muscle relaxant, or daily alcohol use
  • history of alcohol or drug abuse
  • contraindications to diazepam: hepatic or renal dysfunction, myasthenia gravis, acute narrow angle glaucoma, severe respiratory insufficiency, sleep apnea
  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: NCT01233791

Locations
United States, Ohio
Good Samaritan Hospital
Cincinnati, Ohio, United States, 45220
Sponsors and Collaborators
TriHealth Inc.
Investigators
Principal Investigator: Catrina C Crisp, MD TriHealth Inc.
  More Information

No publications provided

Responsible Party: TriHealth Inc.
ClinicalTrials.gov Identifier: NCT01233791     History of Changes
Other Study ID Numbers: 10025-10-021
Study First Received: November 2, 2010
Last Updated: February 20, 2014
Health Authority: US: Institutional Review Board

Keywords provided by TriHealth Inc.:
high tone pelvic floor dysfunction
levator pain
dyspareunia

Additional relevant MeSH terms:
Diazepam
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
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
Adjuvants, Anesthesia

ClinicalTrials.gov processed this record on July 23, 2014