Levator Ani Syndrome Clinical Trial
Official title:
Does Adjunctive Treatment With Vaginal Nifedipine Result in Symptomatic Improvement in Patients With Levator Myalgia and Pelvic Floor Pain Who Are Undergoing Pelvic Floor Physical Therapy?
The objective of this study is to perform a randomized controlled trial among female patients with a diagnosis of pelvic floor hypertonus (extreme muscle tension) with associated pain, dysfunctional voiding, dyspareunia, and/ or obstructed defecation.
Given the paucity of information and the magnitude of debilitation that can be associated
with chronic pain syndromes, the potential to ameliorate pain and successfully treat these
symptoms is an area that merits further exploration. In this study, we hypothesize that the
addition of vaginal nifedipine to a physical therapy protocol will result in greater
treatment success than treatment with physical therapy alone.
The objective is to perform a randomized controlled trial among female participants with a
diagnosis of pelvic floor hypertonus with associated pain, dysfunctional voiding,
dyspareunia, and/or obstructed defecation. Group 1 will serve as the control and will
undergo pelvic floor physical therapy and placebo (lanolin and mineral oil base). Group 2
will also undergo pelvic floor physical therapy, but will receive compounded vaginal
nifedipine.
Specific aims include:
1. Comparison of subjective outcome measures, specifically quality of life metrics scales:
Pelvic Floor Distress Inventory, Pelvic Floor Impact Questionnaire, and validated
11-point pain scale.
2. Comparison of objective outcome measures, specifically a validated digital assessment
of pelvic floor strength: the Oxford scale.
Group 1 will serve as the control and will undergo pelvic floor physical therapy and placebo
(lanolin base). Group 2 will also undergo pelvic floor physical therapy, but will receive
compounded vaginal nifedipine. We will collect data on these patients to determine if the
treatment of vaginal nifedipine with physical therapy provides a more successful treatment
for this pelvic floor dysfunction.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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