Clinical trial NCT01586286: A Study Examining the Use of Vaginal Nifedipine With Pelvic Floor Physical Therapy for Levator Myalgia and Pelvic Pain
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?
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Levator Ani Syndrome
Keywords: Levator Myalgia
Pelvic Pain
Vaginismus
Myofascial pain syndromes
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2012-04-26
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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:

1. 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.
2. 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.

Eligibility 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).

Primary outcomes:
measure: Improvement in Quality of Life
timeFrame: To be assessed 1 month post-treatment.
Secondary outcomes:
measure: Improvement in Hypertonic Pelvic Floor Muscles
timeFrame: To be assessed at baseline and the following post-treatment intervals: 1, 2, 3, and 6 months
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Daniel Biller, MD
role: PRINCIPAL_INVESTIGATOR
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