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?

NCT01586286 NA WITHDRAWN

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.

Details

Lead sponsor	Vanderbilt University
Phase	NA
Status	WITHDRAWN
Start date	2012-07
Completion	2014-05

Conditions

• Levator Ani Syndrome

Interventions

• Nifedipine
• Placebo Ointment Base

Primary outcomes

• Improvement in Quality of Life — To be assessed 1 month post-treatment.
  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).

Countries

United States