Levator Ani Syndrome Clinical Trial
Official title:
Does Adjunctive Treatment With Vaginal Nifedipine Result in Symptomatic Improvement in Patients With Levator Myalgia and Pelvic Floor Pain Who Are Undergoing Pelvic Floor Physical Therapy?
Verified date | May 2014 |
Source | Vanderbilt University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | May 2014 |
Est. primary completion date | May 2014 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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). |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University |
United States,
Bornstein J, Tuma R, Farajun Y, Azran A, Zarfati D. Topical nifedipine for the treatment of localized provoked vulvodynia: a placebo-controlled study. J Pain. 2010 Dec;11(12):1403-9. doi: 10.1016/j.jpain.2010.03.016. Epub 2010 May 26. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | To be assessed 1 month post-treatment. | No |
Secondary | 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. | To be assessed at baseline and the following post-treatment intervals: 1, 2, 3, and 6 months | No |
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