Vaginal Diazepam for the Treatment of Female Pelvic Pain
Primary Purpose
Pelvic Floor Disorders, Pelvic Pain
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Diazepam
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pelvic Floor Disorders focused on measuring High-tone pelvic floor dysfunction, Spasm, Pelvic pain, Diazepam, Female, Randomized trial
Eligibility 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.
Sites / Locations
- Missouri Center for Female Continence and Advanced Pelvic Surgery, University of Missouri Health System
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Diazepam
Placebo
Arm Description
Participated will be instructed to insert one 10mg tablet vaginally 1-2 times per day as needed for pain.
Participated will be instructed to insert one 10mg tablet vaginally 1-2 times per day as needed for pain.
Outcomes
Primary Outcome Measures
Change from baseline in Visual Analog Pain Scale score at 4 weeks, 12 weeks, and 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.
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.
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.
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.
Full Information
NCT ID
NCT01938092
First Posted
August 30, 2013
Last Updated
July 25, 2017
Sponsor
University of Missouri-Columbia
1. Study Identification
Unique Protocol Identification Number
NCT01938092
Brief Title
Vaginal Diazepam for the Treatment of Female Pelvic Pain
Official Title
Intravaginal Diazepam for the Treatment of Pelvic Pain Among Women With Pelvic Floor Hypertonic Disorder: a Double Blind, Randomized, Placebo Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
September 2013 (Actual)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
July 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To determine the efficacy of intravaginal diazepam for the treatment of pelvic pain associated with pelvic floor hypertonic disorder.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Floor Disorders, Pelvic Pain
Keywords
High-tone pelvic floor dysfunction, Spasm, Pelvic pain, Diazepam, Female, Randomized trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diazepam
Arm Type
Active Comparator
Arm Description
Participated will be instructed to insert one 10mg tablet vaginally 1-2 times per day as needed for pain.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participated will be instructed to insert one 10mg tablet vaginally 1-2 times per day as needed for pain.
Intervention Type
Drug
Intervention Name(s)
Diazepam
Other Intervention Name(s)
Valium
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change from baseline in Visual Analog Pain Scale score at 4 weeks, 12 weeks, and 24 weeks.
Description
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.
Time Frame
Initial visit, 4 weeks, 12 weeks, 24 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in Pelvic Floor Distress Inventory-20 Questionnaire score at 4 weeks, 12 weeks, and 24 weeks.
Description
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.
Time Frame
Initial visit, 4 weeks, 12 weeks, 24 weeks
Title
Change from baseline in McGill Pain Questionnaire score at 4 weeks, 12 weeks, and 24 weeks.
Description
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.
Time Frame
Initial visit, 4 weeks, 12 weeks, 24 weeks.
Title
Change from baseline in Global Response Assessment score at 4 weeks, 12 weeks, and 24 weeks.
Description
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.
Time Frame
Initial visit, 4 weeks, 12 weeks, 24 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond T Foster, MD
Organizational Affiliation
University of Missouri-Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Missouri Center for Female Continence and Advanced Pelvic Surgery, University of Missouri Health System
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
29280763
Citation
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.
Results Reference
derived
Learn more about this trial
Vaginal Diazepam for the Treatment of Female Pelvic Pain
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