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

Withdrawn before enrolling · Not applicable · Has a placebo group

Conditions studied: Levator Ani Syndrome

In brief

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.

Key facts

Study ID

NCT01586286

Run by

Vanderbilt University

People needed

0

Starts

2012-07-01

Expected to finish

2014-05-01

Last updated by the study team

2014-05-22

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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).

Where it is running

• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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