Pelvic Floor DyssynergiaBDSNCT03427216
Baclofen/Diazepam Supps for Treatment of Pelvic Floor Myalgia
A study testing Baclofen/diazepam in people with Pelvic Floor Dyssynergia, run by Dr. John A. Thiel Medical Professional Corporation.
Trial summary
This study is a randomized, placebo controlled double blind cross over trial. Patients presenting with pelvic floor myalgia will be asked to complete a series of standardized questionnaires to assess their pain, quality of life and sexual function and satisfaction. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Floor Dyssynergia
- What is being tested?
- Baclofen/diazepam
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2018to 31 Dec 2018
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with significant pelvic floor dyssynergia and pain during sexual activity.
Who cannot join
- Decide you do not wish to participate
- Are pregnant
- Have active pelvic inflammatory disease
- Have an active sexually transmitted infection (STI)
- Have a known or suspected cancer of the genital tract
- Have untreated or unevaluated changes in your Pap smear
Show all 9Show fewer
- Are not currently sexually active
- Have an allergy to either baclofen or valium
- Are unable to complete the necessary study questionnaires
About this study
Official title: A Randomized Double Blind Placebo Controlled Cross-over Trial of Baclofen and Diazepam Suppositories for the Management of Pelvic Floor Myalgia
This study is a randomized, placebo controlled double blind cross over trial. Patients presenting with pelvic floor myalgia will be asked to complete a series of standardized questionnaires to assess their pain, quality of life and sexual function and satisfaction. They will be randomized to either a treatment group or placebo group and will use the supplied suppositories once daily for 2 months. They will then undergo a one month "washout" after which they will be placed in the cross over group for a second two months of treatment.
Primary outcome measure: change in Visual Analogue Scale for Pain (VAS-P) scores before and after treatment Secondary outcome measures: change in Female Sexual Function Index (FSFI), Patient Global Impression of Improvement (PGI-I), and Short Form Health Survey (SF-12) before and after treatment
Read the detailed description
Chronic pelvic pain is a complex multi-faceted problem that places a substantial burden on the healthcare resources. In Canada, the average hospital related cost for women requiring surgery or inpatient admission for chronic pelvic pain is $25 million each year. Chronic pelvic pain is defined as either persistent pain for at least 6 months or "recurrent episodes of abdominal/pelvic pain, hypersensitivity, or discomfort, often associated with elimination changes and sexual dysfunction in the absence of an organic etiology." Chronic pelvic pain is common and affects women of all ages and backgrounds. 15-20% of women have chronic pelvic pain lasting for more than 1 year.
Pelvic floor myalgia is an important and common contributor to chronic pelvic pain that may be present alone or may co-exist with other gynecological, urological, colorectal, and musculoskeletal medical conditions. The International Urogynecological Association/International Continence Society joint report published in February 2017 defines pelvic floor myalgia as pain in the musculature of the pelvic floor.6 Patients with high-tone pelvic floor dysfunction (HTPFD) have levator hypercontractility and present with pain with internal vaginal examination and intercourse. In a 2011 prospective cross-sectional study by Fitzgerald et al., 63% of patients with self-reported chronic pelvic pain examined by a physician and 73.7% of patients examined by a physiotherapist were found to have pelvic floor myalgia. Although pelvic floor myalgia is a common condition encountered in gynecology, it is frequently an unrecognized and under-treated component of chronic pelvic pain. Pelvic floor myalgia has a significant impact on the patient's quality of life. Persistent chronic pain may result in patient's anxiety, low mood, depression, sleep disturbances, feeling of hopelessness and helplessness, frustration, and psychological distress.
The first line of treatment for pelvic floor myalgia is pelvic floor muscle relaxation. Reducing the resting tone of pelvic floor musculature has been shown to improve chronic pelvic pain. Current treatment options for pelvic floor myalgia include pelvic floor physiotherapy, Thiele massage, biofeedback with electrical stimulation, behavioural modifications, acupuncture, medications such as antidepressants,1 trigger point injections with botulin A toxin, warm sitz baths, and neuromodulation.
Recently, intravaginal diazepam has been used an off-label treatment option for high-tone pelvic floor myalgia. Diazepam is a benzodiazepine derivative that has both antispasmotic and anxiolytic activity. It is used as a muscle relaxant and enhances the inhibitory action of gamma-amino butyric acid (GABA) on neuronal excitability, resulting in decreased action potentials. The benefit of local therapy is the avoidance of the common side effects of benzodiazepines such as drowsiness, fatigue, and ataxia. Currently, evidence is lacking in regards to the effectiveness of intravaginal diazepam on treatment of chronic pelvic pain. The 2010 retrospective chart review of 26 patients by Rogalski et al. revealed clinically significant reduction in Visual Analogue Scale for Pain (VAS-P) and Female Sexual Function Index (FSFI) with diazepam suppositories used for 30 days as an adjuvant therapy to pelvic floor physiotherapy and intramuscular trigger point injections. Similarly, the 2011 study revealed 62% improvement in symptoms with intravaginal diazepam.
Baclofen is a skeletal muscle relaxant. It is a GABA-B receptor agonist which is commonly used for treating spasticity. The literature on topical baclofen use in pelvic floor dysfunction is minimal. Topical therapy is advantageous to avoid the common systemic side effects such as drowsiness, hypotonia, hypotension, and headache. A retrospective study examining the use of topical baclofen for provoked vulvodynia showed an improvement in pain and sexual function.
Baclofen may also be used in combination with diazepam for treatment of pelvic floor myalgia. A 2016 retrospective chart review performed at the University of Saskatchewan revealed a reduction in both dyspareunia and pelvic floor muscle spasm with the use of baclofen and diazepam vaginal suppositories.
- Conditions
- Pelvic Floor Dyssynergia
- Being tested
- Baclofen/diazepam, Vaginal placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baclofen/diazepamDrug
Also called Lioresal
Vaginal suppository placed once daily, patients will record pelvic pain daily on a VAS scale, sexual satisfaction and quality of life on a standardized questionnaire weekly
Vaginal placeboDrug
Also called suppository
Vaginal suppository placed once daily, patient will record pelvic pain daily on a VAS scale, sexual satisfaction and quality of life on a standardized questionnaire weeky.
| Study group | Role | What they receive |
|---|---|---|
| Vaginal Baclofen/diazepam supp | Active comparator | Insert vaginal suppository once daily Receives: Drug: Baclofen/diazepam |
| Vaginal Placebo supp | Placebo comparator | Insert vaginal suppository once daily Receives: Drug: Vaginal placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visual Analogue Scale for Pain (VAS-P) scores before and after treatment
The scale ranges from 0 (no pain) to 10 (worst pain ever experienced)
Measured: 5 months
Secondary outcomes (3)
Change in Female Sexual Function Index (FSFI)
Self report measure of female sexual dysfunction
Measured: 5 months
Patient Global Impression of Improvement (PGI-I)
Ranks patients overall feeling about health from 1 (very much better) to 7 (very much worse)
Measured: 5 months
Short form Health Survey (SF-12)
Standardized self assessment tool to measure overall health status
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study start1 Sep 2018 (estimated)
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Floor DyssynergiaStudies 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. John A. Thiel Medical Professional Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Thiel, Dr. John A. Thiel Medical Professional Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03427216
- Sponsor's protocol ID
- Jthiel
- Acronym
- BDS
- Status last verified
- Jun 2018
- First submitted
- 26 Jan 2018
- Last updated
- 7 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: only pooled data will be shared outside of the research team
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double Blind Placebo Controlled Cross-over Trial of Baclofen and Diazepam Suppositories for the Management of Pelvic Floor Myalgia
- ClinicalTrials.gov ID
- NCT03427216
- Acronym / sponsor ID
- BDS / Jthiel
- Conditions
- Pelvic Floor Dyssynergia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Dr. John A. Thiel Medical Professional CorporationUniversity, hospital or other
- Study start
- 1 Sep 2018 (estimated)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 9 Feb 2018 (actual)
- 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.
This study is a randomized, placebo controlled double blind cross over trial. Patients presenting with pelvic floor myalgia will be asked to complete a series of standardized questionnaires to assess their pain, quality of life and sexual function and satisfaction. They will be randomized to either a treatment group or placebo group and will use the supplied suppositories once daily for 2 months. They will then undergo a one month "washout" after which they will be placed in the cross over group for a second two months of treatment.
Primary outcome measure: change in Visual Analogue Scale for Pain (VAS-P) scores before and after treatment Secondary outcome measures: change in Female Sexual Function Index (FSFI), Patient Global Impression of Improvement (PGI-I), and Short Form Health Survey (SF-12) before and after treatment
Detailed description
Chronic pelvic pain is a complex multi-faceted problem that places a substantial burden on the healthcare resources. In Canada, the average hospital related cost for women requiring surgery or inpatient admission for chronic pelvic pain is $25 million each year. Chronic pelvic pain is defined as either persistent pain for at least 6 months or "recurrent episodes of abdominal/pelvic pain, hypersensitivity, or discomfort, often associated with elimination changes and sexual dysfunction in the absence of an organic etiology." Chronic pelvic pain is common and affects women of all ages and backgrounds. 15-20% of women have chronic pelvic pain lasting for more than 1 year.
Pelvic floor myalgia is an important and common contributor to chronic pelvic pain that may be present alone or may co-exist with other gynecological, urological, colorectal, and musculoskeletal medical conditions. The International Urogynecological Association/International Continence Society joint report published in February 2017 defines pelvic floor myalgia as pain in the musculature of the pelvic floor.6 Patients with high-tone pelvic floor dysfunction (HTPFD) have levator hypercontractility and present with pain with internal vaginal examination and intercourse. In a 2011 prospective cross-sectional study by Fitzgerald et al., 63% of patients with self-reported chronic pelvic pain examined by a physician and 73.7% of patients examined by a physiotherapist were found to have pelvic floor myalgia. Although pelvic floor myalgia is a common condition encountered in gynecology, it is frequently an unrecognized and under-treated component of chronic pelvic pain. Pelvic floor myalgia has a significant impact on the patient's quality of life. Persistent chronic pain may result in patient's anxiety, low mood, depression, sleep disturbances, feeling of hopelessness and helplessness, frustration, and psychological distress.
The first line of treatment for pelvic floor myalgia is pelvic floor muscle relaxation. Reducing the resting tone of pelvic floor musculature has been shown to improve chronic pelvic pain. Current treatment options for pelvic floor myalgia include pelvic floor physiotherapy, Thiele massage, biofeedback with electrical stimulation, behavioural modifications, acupuncture, medications such as antidepressants,1 trigger point injections with botulin A toxin, warm sitz baths, and neuromodulation.
Recently, intravaginal diazepam has been used an off-label treatment option for high-tone pelvic floor myalgia. Diazepam is a benzodiazepine derivative that has both antispasmotic and anxiolytic activity. It is used as a muscle relaxant and enhances the inhibitory action of gamma-amino butyric acid (GABA) on neuronal excitability, resulting in decreased action potentials. The benefit of local therapy is the avoidance of the common side effects of benzodiazepines such as drowsiness, fatigue, and ataxia. Currently, evidence is lacking in regards to the effectiveness of intravaginal diazepam on treatment of chronic pelvic pain. The 2010 retrospective chart review of 26 patients by Rogalski et al. revealed clinically significant reduction in Visual Analogue Scale for Pain (VAS-P) and Female Sexual Function Index (FSFI) with diazepam suppositories used for 30 days as an adjuvant therapy to pelvic floor physiotherapy and intramuscular trigger point injections. Similarly, the 2011 study revealed 62% improvement in symptoms with intravaginal diazepam.
Baclofen is a skeletal muscle relaxant. It is a GABA-B receptor agonist which is commonly used for treating spasticity. The literature on topical baclofen use in pelvic floor dysfunction is minimal. Topical therapy is advantageous to avoid the common systemic side effects such as drowsiness, hypotonia, hypotension, and headache. A retrospective study examining the use of topical baclofen for provoked vulvodynia showed an improvement in pain and sexual function.
Baclofen may also be used in combination with diazepam for treatment of pelvic floor myalgia. A 2016 retrospective chart review performed at the University of Saskatchewan revealed a reduction in both dyspareunia and pelvic floor muscle spasm with the use of baclofen and diazepam vaginal suppositories.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaginal Baclofen/diazepam supp | Active comparator | Drug: Baclofen/diazepamInsert vaginal suppository once daily |
| Vaginal Placebo supp | Placebo comparator | Drug: Vaginal placeboInsert vaginal suppository once daily |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with significant pelvic floor dyssynergia and pain during sexual activity.
Key exclusion criteria (9 listed)
- Decide you do not wish to participate
- Are pregnant
- Have active pelvic inflammatory disease
- Have an active sexually transmitted infection (STI)
- Have a known or suspected cancer of the genital tract
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 |
|---|---|---|
| Baclofen/diazepamAlso: LioresalVaginal suppository placed once daily, patients will record pelvic pain daily on a VAS scale, sexual satisfaction and quality of life on a standardized questionnaire weekly | Drug | Vaginal Baclofen/diazepam supp |
| Vaginal placeboAlso: suppositoryVaginal suppository placed once daily, patient will record pelvic pain daily on a VAS scale, sexual satisfaction and quality of life on a standardized questionnaire weeky. | Drug | Vaginal Placebo supp |
Primary outcome
Change in Visual Analogue Scale for Pain (VAS-P) scores before and after treatment
Time frame: 5 months
The scale ranges from 0 (no pain) to 10 (worst pain ever experienced)
3 secondary outcomes
Change in Female Sexual Function Index (FSFI)
Time frame: 5 months
Patient Global Impression of Improvement (PGI-I)
Time frame: 5 months
Short form Health Survey (SF-12)
Time frame: 5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2018.
- Individual participant dataSharing planned: No. only pooled data will be shared outside of the research team
Related trials for Pelvic Floor Dyssynergia
Recruiting
Efficacy of Low-intensity Shockwave vs Radial Wave for Treatment of Erectile Dysfunction and Pelvic Pain
Erectile Dysfunction Due to Arterial Insufficiency, Erectile Dysfunction
Not yet recruitingObservational study
Dynamics of Pelvic Floor Muscles With Different Phonation Patterns Among Female Students
Pelvic Floor Dyssynergia, Phonation Disorder
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Baclofen/diazepam in people with Pelvic Floor Dyssynergia, run by Dr. John A. Thiel Medical Professional Corporation.
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 1 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 7 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Change in Visual Analogue Scale for Pain (VAS-P) scores before and after treatment (time frame: 5 months). 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 7 Jun 2018.