Pelvic Floor DisordersPhase 2NCT01938092
Vaginal Diazepam for the Treatment of Female Pelvic Pain
A Phase 2 study testing Diazepam in people with Pelvic Floor Disorders and Pelvic Pain, run by Raymond Foster at 1 site in United States.
Trial summary
To determine the efficacy of intravaginal diazepam for the treatment of pelvic pain associated with pelvic floor hypertonic disorder. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Floor Disorders, Pelvic Pain
- What is being tested?
- Diazepam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Jul 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Missouri Center for Female Continence and Advanced Pelvic Surgery, University of Missouri Health System
Columbia, Missouri, 65201
About this study
Official title: Intravaginal Diazepam for the Treatment of Pelvic Pain Among Women With Pelvic Floor Hypertonic Disorder: a Double Blind, Randomized, Placebo Controlled Trial
To determine the efficacy of intravaginal diazepam for the treatment of pelvic pain associated with pelvic floor hypertonic disorder.
Read the 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.
- Conditions
- Pelvic Floor Disorders, Pelvic Pain
- Being tested
- Diazepam, Placebo
- Keywords
- High-tone pelvic floor dysfunction, Spasm, Pelvic pain, Diazepam, Female, Randomized trial
- Medical subject headings
- Pelvic Floor Disorders, Pelvic Pain, Spasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiazepamDrug
Also called Valium
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Diazepam | Active comparator | Participated will be instructed to insert one 10mg tablet vaginally 1-2 times per day as needed for pain. Receives: Drug: Diazepam |
| Placebo | Placebo comparator | Participated will be instructed to insert one 10mg tablet vaginally 1-2 times per day as needed for pain. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 4 weeks
Secondary outcomes (2)
Pelvic Floor Distress Inventory-20 (PFDI-20) Questionnaire Score at 4 Weeks.
The Pelvic Floor Distress Inventory-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 a minimum score of 0 (least distress) to a maximum of 100 (greatest distress), thus a higher score indicates a poorer outcome. The scores from each of the 3 scales are added together to give a summary score (range 0 to 300). The PFDI-20 questionnaire was administered at baseline and at 4 weeks of treatment. The outcome was the score at 4 weeks of treatment.
Measured: 4 weeks
McGill Pain Questionnaire Score (PRI) at 4 Weeks
The McGilll pain questionnaire is a validated instrument that assigns quantitative value to qualitative descriptions of chosen by the patient. The minimum pain score is 0 (would not be seen in a person with true pain) and the maximum pain score: 78. The higher the pain score the greater the pain and the poorer the outcome. measured at 4 weeks.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionMar 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pelvic Floor DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Raymond Foster
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Raymond Foster, University of Missouri-Columbia
- Investigators
- Raymond T Foster, MD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01938092
- Sponsor's protocol ID
- 1208827
- Status last verified
- Aug 2024
- First submitted
- 30 Aug 2013
- Last updated
- 3 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 29280763
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravaginal Diazepam for the Treatment of Pelvic Pain Among Women With Pelvic Floor Hypertonic Disorder: a Double Blind, Randomized, Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT01938092
- Acronym / sponsor ID
- 1208827
- Conditions
- Pelvic Floor Disorders, Pelvic Pain
- Keywords
- High-tone pelvic floor dysfunction, Spasm, Pelvic pain, Diazepam, Female, Randomized trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Raymond FosterUniversity, hospital or other
- Study start
- Sep 2013 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 10 Sep 2013 (estimated)
- Results
- Posted 3 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diazepam | Active comparator | Drug: DiazepamParticipated will be instructed to insert one 10mg tablet vaginally 1-2 times per day as needed for pain. |
| Placebo | Placebo comparator | Drug: PlaceboParticipated will be instructed to insert one 10mg tablet vaginally 1-2 times per day as needed for pain. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- Chronic narcotic use
- Non-English speaking
- Currently serving a prison sentence
- Stage III or greater vaginal prolapse
- Allergies or contraindications to benzodiazepines
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DiazepamAlso: Valium | Drug | Diazepam |
| Placebo | Drug | Placebo |
Primary outcome
Visual Analog Scale (VAS) for Pain
Time frame: Baseline and 4 weeks
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.
2 secondary outcomes
Pelvic Floor Distress Inventory-20 (PFDI-20) Questionnaire Score at 4 Weeks.
Time frame: 4 weeks
McGill Pain Questionnaire Score (PRI) at 4 Weeks
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29280763Holland 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raymond T Foster, MD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Diazepam in people with Pelvic Floor Disorders and Pelvic Pain, run by Raymond Foster at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) for Pain (time frame: Baseline and 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01938092, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2024.