NCT01586286

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

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?

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Vanderbilt University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Levator Ani Syndrome

Interventions

Type	Name	Description
DRUG	Nifedipine	Nifedipine - 0.2% concentration in a lanolin base; administered twice per day for 28 days; as a vaginal ointment applied to vulvar and vaginal area
DRUG	Placebo Ointment Base	Placebo administered twice per day for 28 days; as a vaginal ointment applied to vulvar and vaginal area

Timeline

• Start date: 2012-07-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2012-04-26
• Last updated: 2014-05-22

Locations

1 site across 1 country: United States