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

NCT ID: NCT01586286

Last Updated: 2014-05-22

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2014-05-31

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.

Conditions

Levator Ani Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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).

Group Type: PLACEBO_COMPARATOR

Placebo Ointment Base

Intervention Type: DRUG

Placebo administered twice per day for 28 days; as a vaginal ointment applied to vulvar and vaginal area

Nifedipine Ointment

Patients in this arm will undergo pelvic floor physical therapy, but will receive compounded vaginal nifedipine.

Group Type: ACTIVE_COMPARATOR

Nifedipine

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Placebo Ointment Base

Placebo administered twice per day for 28 days; as a vaginal ointment applied to vulvar and vaginal area

Intervention Type: DRUG

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University

OTHER

Sponsor Role: lead

Responsible Party

Daniel Biller

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel Biller, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

References

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Other Identifiers

111573

Identifier Type: -

Identifier Source: org_study_id