A Study Examining the Use of Vaginal Nifedipine With Pelvic Floor Physical Therapy for Levator My… (NCT01586286) | Clinical Trial Compass
WithdrawnNot Applicable
A Study Examining the Use of Vaginal Nifedipine With Pelvic Floor Physical Therapy for Levator Myalgia and Pelvic Pain
Stopped: No patients were recruited over a 12 month period
United States0Started 2012-07
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).