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

Vanderbilt University

Status

Withdrawn

Conditions

Levator Ani Syndrome

Treatments

Drug: Placebo Ointment Base

Drug: Nifedipine

Study type

Interventional

Funder types

Other

Identifiers

NCT01586286

111573

Details and patient eligibility

About

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.

Full description

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.

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).