A Study Examining the Use of Vaginal Nifedipine With Pelvic Floor Physical Therapy for Levator Myalgia and Pelvic Pain

Study Overview
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Brief Summary
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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.

Detailed Description
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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: 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. 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.

Official Title
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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?

Conditions
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Levator Ani Syndrome

Intervention / Treatment
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* Drug: Nifedipine
* Drug: Placebo Ointment Base


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has levator myalgia upon appropriate pelvic exam that reproduces HPI pain Subject has symptoms such as voiding dysfunction, dyspareunia, vaginismus, or obstructed defecation Subject is willing and able to give written consent for the study Subject is willing to undergo treatment with pelvic physical therapy & vaginal nifedipine Subject is able to speak, read, and write in English Subject is at least 18 years of age Exclusion Criteria: Subject has previously diagnosed interstitial cystitis Subject has an active case of symptomatic HSV, syphilis, or shingles Subject has a history of uncontrolled hypertension Subject is already taking a calcium channel blocker Subject has a history of MI, CHF, or arrhythmia Subject has a history of neurologic disease Subject has a history of congenital or progressive musculoskeletal disease Subject has a history of bladder or pelvic cancer and/or pelvic radiation Subject is planning to be or currently pregnant Subject has known allergy or adverse reaction to nifedipine Subject has known allergy or adverse reaction to lanolin, mineral oil, petrolatum Subject is undergoing pharmacologic treatment specific to pelvic pain Subject is taking oral beta adrenergic antagonist medication Subject has an active pelvic or vaginal infection Subjects with hypotension on screening physical examination (i.e. confirmed SBP<90 mmHg or DBP<60 mmHg).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Ointment Base<br>Patients in this arm will serve as the control and will undergo pelvic floor physical therapy and receive placebo (lanolin and mineral oil base). | Drug: Placebo Ointment Base<br>* Placebo administered twice per day for 28 days; as a vaginal ointment applied to vulvar and vaginal area<br>|
| Active Comparator: Nifedipine Ointment<br>Patients in this arm will undergo pelvic floor physical therapy, but will receive compounded vaginal nifedipine. | Drug: Nifedipine<br>* Nifedipine - 0.2% concentration in a lanolin base; administered twice per day for 28 days; as a vaginal ointment applied to vulvar and vaginal area<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Quality of Life | The primary outcome will measure quality of life metrics, as reported by the patient herself. We will use the following validated instruments: Pelvic Floor Distress Inventory, Pelvic Floor Impact Questionnaire, and validated 11-point pain scale. The aim is to measure whether the patient experienced improvement in her symptoms when vaginal nifedipine was administered (in addition to physical therapy). | To be assessed 1 month post-treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Hypertonic Pelvic Floor Muscles | The secondary outcome measure will be assessed and reported by the healthcare provider at the above visits. After instructing the patient to voluntarily relax the pelvic floor muscles, the resting tone will be measured using the Oxford scale, which is a validated digital assessment. | To be assessed at baseline and the following post-treatment intervals: 1, 2, 3, and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Levator Myalgia, Pelvic Pain, Vaginismus, Myofascial pain syndromes