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Compares treatment options for High Tone Pelvic Floor Dysfunction
Official title Comparing Adjuvant Treatments for High Tone Pelvic Floor Dysfunction
ClinicalTrials.gov ID: NCT07404397
What this study is testing
What is Cyclobenzaprine?
Cyclobenzaprine is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for high tone pelvic floor dysfunction.
Also referred to as Flexeril.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The researchers are comparing two treatments for high tone pelvic floor dysfunction (HTPFD) in conjunction with pelvic floor physical therapy (PFPT). The goal of this study is to find out which of two extra treatments works better for people with HTPFD when they also do regular PFPT.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65, women only
You may be able to join if
- Self-reported moderate to severe chronic pelvic pain for \>6 months duration at time of screening visit. Moderate to severe chronic pain is defined...
- Diagnosis of high tone pelvic floor dysfunction (HTPFD), defined as \>12/60 summative pelvic floor tenderness score on standardized pelvic...
- Referred to pelvic floor physical therapy (PFPT) by their chronic pelvic pain specialist for management of HTPFD
- Willing to undergo a 12-session course of PFPT for HTPFD, including internal/vaginal tissue manipulation per standardized protocol
- Willing to delay start of PFPT until Phase 2 of the trial
You likely can't join if
- Hypersensitivity or allergy to cyclobenzaprine or any component of cyclobenzaprine
- Underwent PFPT within 6 months of screening date
- Pregnancy at any point during study period (self-reported home urine pregnancy test or serum b-Hcg test, positive urine pregnancy test at baseline...
- Currently breastfeeding at time of screening visit
- Scheduled for or are planning moderate/major gynecologic surgery (including hysterectomy, excision of endometriosis, ovarian cystectomy/oopherectomy...
- Current (at time of screening visit) diagnosis of postural orthostatic tachycardia syndrome
See the full eligibility criteria
- Self-reported moderate to severe chronic pelvic pain for \>6 months duration at time of screening visit. Moderate to severe chronic pain is defined as \>4 on 0-10 (worst daily pain) for \>14 days per month. Pelvic pain...
- Diagnosis of high tone pelvic floor dysfunction (HTPFD), defined as \>12/60 summative pelvic floor tenderness score on standardized pelvic examination by chronic pelvic pain specialist (MD or NP) within the past year
- Referred to pelvic floor physical therapy (PFPT) by their chronic pelvic pain specialist for management of HTPFD
- Willing to undergo a 12-session course of PFPT for HTPFD, including internal/vaginal tissue manipulation per standardized protocol
- Willing to delay start of PFPT until Phase 2 of the trial
- Willing to be assigned by chance to either daily use of cyclobenzaprine or use of vibrating pelvic floor muscle massage wand for total of 18 weeks
- Willing to undergo standardized pelvic floor myofascial exam three times over the study period (baseline, end of Phase 1, end of Phase 2)
- Willing to undergo quantitative sensory testing (QST) two times over the study period (baseline, end of Phase 1)
- Willing to undergo blood draw two times over the study period (baseline, end of Phase 1)
- Ability to read and speak English to allow for written informed consent, phenotyping, and patient-reported outcome measures
- No plans for pregnancy within the next 12 months
- Hypersensitivity or allergy to cyclobenzaprine or any component of cyclobenzaprine
- Underwent PFPT within 6 months of screening date
- Pregnancy at any point during study period (self-reported home urine pregnancy test or serum b-Hcg test, positive urine pregnancy test at baseline, post-Phase 1, or post-Phase 2 study visits).
- Currently breastfeeding at time of screening visit
- Scheduled for or are planning moderate/major gynecologic surgery (including hysterectomy, excision of endometriosis, ovarian cystectomy/oopherectomy, myomectomy) within the following 6 months of screening date
- Current (at time of screening visit) diagnosis of postural orthostatic tachycardia syndrome
- Current significant neurologic or musculoskeletal conditions that would preclude participation in PFPT (cerebral palsy, severe hip/back osteoarthritis that would prevent lithotomy position during sessions)
- Unwilling to avoid or stop baseline use of cyclobenzaprine and other muscle relaxants (including methocarbamol, tizanidine, baclofen, carisoprodol, metaxalone)
- Current use of tricyclic antidepressants
- Current use of monoamine oxidase inhibitor
- Current use of vaginally delivered benzodiazepine such as diazepam (more than once per month) and unwilling to stop use of vaginally delivered benzodiazepine for the duration of this study
- Current diagnosis of hyperthyroidism
- Current diagnosis of moderate or severe hepatic impairment
- Myocardial infarction within prior 12 months
- Current diagnosis of congestive heart failure
- Current cardiac pacemaker in place
- Current diagnosis of closed angle glaucoma
- Current major psychiatric condition (including psychosis or suicidal ideation within past year)
The study team makes the final eligibility decision.
Where it's taking place
- Ann Arbor, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ann Arbor, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.