An interventional study of Baclofen/diazepam and Vaginal placebo in Pelvic Floor Dyssynergia, sponsored by Dr. John A. Thiel Medical Professional Corporation. Status unknown. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-07.
Sponsored by Dr. John A. Thiel Medical Professional Corporation · Not applicable, Interventional, and Treatment
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
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.
149 studies on the registry are indexed under Ataxia; 37 are open to participants now.
This study's planned enrollment of 60 is above the median of 30 across 100 interventional studies indexed under Ataxia.
Browse Ataxia studies →Dr. John A. Thiel Medical Professional Corporation is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Insert vaginal suppository once daily
Drug: Baclofen/diazepam
Insert vaginal suppository once daily
Drug: Vaginal placebo
Drug pages: Baclofen · Diazepam
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
Also known as: Lioresal
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.
Also known as: suppository
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)
Time frame: 5 months
Change in Female Sexual Function Index (FSFI)
Self report measure of female sexual dysfunction
Time frame: 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)
Time frame: 5 months
Short form Health Survey (SF-12)
Standardized self assessment tool to measure overall health status
Time frame: 5 months
No study locations are listed for this record.
Plan to share: No — only pooled data will be shared outside of the research team
No publications or documents are linked to this record.
Start is estimated for Sep 2018; primary completion for Dec 2018, 3 months later.
Of 53 non-industry interventional studies with no phase under Ataxia, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 34. This study's planned 3 months is below that.
Counting every sponsor, half of 55 studies reached it within 19 months; a quarter within 7 and three quarters within 33.
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This study is status unknown, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Baclofen · Diazepam
Dr. John A. Thiel Medical Professional Corporation