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

• Status: Withdrawn
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt University
• Treatments: Nifedipine

Criteria

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).