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

Sponsor

Vanderbilt University (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01586286

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Levator Ani Syndrome	Drug: Nifedipine Drug: Placebo Ointment Base	N/A

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:

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.
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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, 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?

Study Start Date :

Jul 1, 2012

Anticipated Primary Completion Date :

May 1, 2014

Anticipated Study Completion Date :

May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

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).

Secondary Outcome Measures

Improvement in Hypertonic Pelvic Floor Muscles [To be assessed at baseline and the following post-treatment intervals: 1, 2, 3, and 6 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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).