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

This study has been withdrawn prior to enrollment.
(No patients were recruited over a 12 month period)
Sponsor:
Information provided by (Responsible Party):
Daniel Biller, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01586286
First received: April 20, 2012
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Levator Ani Syndrome
Drug: Nifedipine
Drug: Placebo Ointment Base

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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?

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Improvement in Quality of Life [ Time Frame: To be assessed 1 month post-treatment. ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Improvement in Hypertonic Pelvic Floor Muscles [ Time Frame: To be assessed at baseline and the following post-treatment intervals: 1, 2, 3, and 6 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 0
Study Start Date: July 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Ointment Base
Patients in this arm will serve as the control and will undergo pelvic floor physical therapy and receive placebo (lanolin and mineral oil base).
Drug: Placebo Ointment Base
Placebo administered twice per day for 28 days; as a vaginal ointment applied to vulvar and vaginal area
Active Comparator: Nifedipine Ointment
Patients in this arm will undergo pelvic floor physical therapy, but will receive compounded vaginal nifedipine.
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01586286

Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Daniel Biller, MD Vanderbilt University
  More Information

Publications:

Responsible Party: Daniel Biller, Assistant Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01586286     History of Changes
Other Study ID Numbers: 111573
Study First Received: April 20, 2012
Last Updated: May 21, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Vanderbilt University:
Levator Myalgia
Pelvic Pain
Vaginismus
Myofascial pain syndromes

Additional relevant MeSH terms:
Pelvic Pain
Anus Diseases
Pain
Signs and Symptoms
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Neurologic Manifestations
Nervous System Diseases
Nifedipine
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on July 24, 2014