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

Vanderbilt University

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Conditions

Levator Ani Syndrome

Interventions

NifedipineDRUG

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

Placebo Ointment BaseDRUG

Placebo administered twice per day for 28 days; as a vaginal ointment applied to vulvar and vaginal area

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (1)

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

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).

Time frame: To be assessed 1 month post-treatment.

Secondary Outcomes

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.

Time frame: To be assessed at baseline and the following post-treatment intervals: 1, 2, 3, and 6 months

Data from ClinicalTrials.gov

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