Female Patients With High Tone Pelvic Floor DysfunctionNCT01233791
Diazepam Vaginal Suppositories for High Tone Pelvic Floor Dysfunction.
A study testing Vaginal Diazepam Suppository in people with Female Patients With High Tone Pelvic Floor Dysfunction, run by TriHealth Inc. at 1 site in United States.
Trial summary
The purpose of this study is to determine whether vaginal diazepam suppositories are an effective treatment of high tone pelvic floor dysfunction. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Female Patients With High Tone Pelvic Floor Dysfunction
- What is being tested?
- Vaginal Diazepam Suppository
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- candidates from the Division of Urogynecology at Good Samaritan Hospital in Cincinnati, OH
- aged 18-65
- high tone pelvic floor dysfunction
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diazepam Vaginal Suppositories as a Treatment Option for High Tone PElvic Floor Dysfunction: A Randomized Controlled Trial.
The purpose of this study is to determine whether vaginal diazepam suppositories are an effective treatment of high tone pelvic floor dysfunction.
Read the 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.
- Being tested
- Vaginal Diazepam Suppository, Placebo Suppository
- Keywords
- high tone pelvic floor dysfunction, levator pain, dyspareunia
- Medical subject headings
- Dyspareunia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal Diazepam SuppositoryDrug
10mg compounded vaginal suppository
Placebo SuppositoryDrug
Patients will be asked to use one vaginal suppository every night for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Vaginal Diazepam Suppository | Experimental | Patients in this arm will be asked to use one vaginal suppository every night for 28 days Receives: Drug: Vaginal Diazepam Suppository |
| Vaginal Placebo Suppository | Placebo comparator | Patients will be asked to use one vaginal suppository every night for 28 days Receives: Drug: Placebo Suppository |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surface EMG
A baseline sEMG will be compared to sEMG after 28 days of treatment.
Measured: After 28 days of treatment
Secondary outcomes (6)
Surface EMG Midpoint
A baseline sEMG will be compared to sEMG after 14 days of treatment.
Measured: 14 days after treatment
FSFI
Baseline FSFI scores will be compared to scores after 4 weeks of treatment to asses sexual function
Measured: 28 days
VAS
Visual analog scale for pain will be collected at baseline and compared to VAS after 28 days of treatment
Measured: 28 days
SF-12
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.
Measured: 28 days
PGI-I
Patient Global Impression of Improvement will be asked after 28 days of treatment to determine if the patient felt the treatment was helpful
Measured: 28 days
PGI-S
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
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Patients With High Tone Pelvic Floor DysfunctionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- TriHealth Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catrina C Crisp, MD, Principal investigator, TriHealth Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01233791
- Sponsor's protocol ID
- 10025-10-021
- Status last verified
- Jul 2015
- First submitted
- 2 Nov 2010
- Last updated
- 10 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diazepam Vaginal Suppositories as a Treatment Option for High Tone PElvic Floor Dysfunction: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT01233791
- Acronym / sponsor ID
- 10025-10-021
- Keywords
- high tone pelvic floor dysfunction, levator pain, dyspareunia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- TriHealth Inc.University, hospital or other
- Study start
- Nov 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 3 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether vaginal diazepam suppositories are an effective treatment of high tone pelvic floor dysfunction.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaginal Diazepam Suppository | Experimental | Drug: Vaginal Diazepam SuppositoryPatients in this arm will be asked to use one vaginal suppository every night for 28 days |
| Vaginal Placebo Suppository | Placebo comparator | Drug: Placebo SuppositoryPatients will be asked to use one vaginal suppository every night for 28 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- candidates from the Division of Urogynecology at Good Samaritan Hospital in Cincinnati, OH
- aged 18-65
- high tone pelvic floor dysfunction
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Vaginal Diazepam Suppository10mg compounded vaginal suppository | Drug | Vaginal Diazepam Suppository |
| Placebo SuppositoryPatients will be asked to use one vaginal suppository every night for 28 days | Drug | Vaginal Placebo Suppository |
Primary outcome
Surface EMG
Time frame: After 28 days of treatment
A baseline sEMG will be compared to sEMG after 28 days of treatment.
6 secondary outcomes
Surface EMG Midpoint
Time frame: 14 days after treatment
FSFI
Time frame: 28 days
VAS
Time frame: 28 days
SF-12
Time frame: 28 days
PGI-I
Time frame: 28 days
PGI-S
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2015.
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.
Catrina C Crisp, MD principal investigator
TriHealth Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaginal Diazepam Suppository in people with Female Patients With High Tone Pelvic Floor Dysfunction, run by TriHealth Inc. 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 3 inclusion and 7 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 10 Jul 2015. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Surface EMG (time frame: After 28 days of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jul 2015.