ClinicalTrials.gg
Status unknownNCT03427216BDSUpdated Jun 7, 2018

Baclofen/Diazepam Supps for Treatment of Pelvic Floor Myalgia

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

The sponsor has not verified this record recently (last verified Jun 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Female
01

Study 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. 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.

02

Conditions studied

  • Pelvic Floor Dyssynergia

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03

In context

Ataxia

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 →

Lead sponsor

Dr. John A. Thiel Medical Professional Corporation is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with significant pelvic floor dyssynergia and pain during sexual activity.

Exclusion criteria

Exclusion Criteria:

  • 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
  • Are not currently sexually active
  • Have an allergy to either baclofen or valium
  • Are unable to complete the necessary study questionnaires
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Vaginal Baclofen/diazepam supp

    Insert vaginal suppository once daily

    Drug: Baclofen/diazepam

  • Placebo comparator
    Vaginal Placebo supp

    Insert vaginal suppository once daily

    Drug: Vaginal placebo

Interventions

  • DrugBaclofen/diazepam

    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

  • DrugVaginal placebo

    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

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Change in Female Sexual Function Index (FSFI)

    Self report measure of female sexual dysfunction

    Time frame: 5 months

  2. 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

  3. Short form Health Survey (SF-12)

    Standardized self assessment tool to measure overall health status

    Time frame: 5 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — only pooled data will be shared outside of the research team

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

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.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 26, 2018
First posted
Feb 9, 2018
StartEst.
Sep 1, 2018
Primary completionEst.
Dec 31, 2018
CompletionEst.
Dec 31, 2018
Last update
Jun 7, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 7, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03427216
Lead sponsor
Dr. John A. Thiel Medical Professional Corporation
Responsible party
John Thiel (Clinical Professor, Dr. John A. Thiel Medical Professional Corporation) — Principal investigator
First posted
Feb 9, 2018
Start date
Sep 1, 2018 (estimated)
Primary completion
Dec 31, 2018 (estimated)
Completion
Dec 31, 2018 (estimated)
Last update
Jun 7, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Baclofen · Diazepam

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