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

NCT01586286 | Withdrawn

• 1 other identifier: 111573
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Levator Ani Syndrome

Keywords

Levator Myalgia; Pelvic Pain; Vaginismus; Myofascial pain syndromes

Outcome Measures

Primary Outcomes (1)

• Improvement in Quality of Life

  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).

  To be assessed 1 month post-treatment.

Secondary Outcomes (1)

• Improvement in Hypertonic Pelvic Floor Muscles

  To be assessed at baseline and the following post-treatment intervals: 1, 2, 3, and 6 months

Study Arms (2)

Ointment Base

PLACEBO COMPARATOR

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

Nifedipine Ointment

ACTIVE COMPARATOR

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

Drug: Nifedipine

Interventions

Nifedipine 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

Nifedipine Ointment

Placebo Ointment Base DRUG

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

Ointment Base

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (9)

• Mathias SD, Kuppermann M, Liberman RF, Lipschutz RC, Steege JF. Chronic pelvic pain: prevalence, health-related quality of life, and economic correlates. Obstet Gynecol. 1996 Mar;87(3):321-7. doi: 10.1016/0029-7844(95)00458-0.

  PMID: 8598948 BACKGROUND

• Reiter RC. A profile of women with chronic pelvic pain. Clin Obstet Gynecol. 1990 Mar;33(1):130-6. No abstract available.

  PMID: 2178830 BACKGROUND

• Butrick CW. Pelvic floor hypertonic disorders: identification and management. Obstet Gynecol Clin North Am. 2009 Sep;36(3):707-22. doi: 10.1016/j.ogc.2009.08.011.

  PMID: 19932423 BACKGROUND

• Rosenbaum TY, Owens A. The role of pelvic floor physical therapy in the treatment of pelvic and genital pain-related sexual dysfunction (CME). J Sex Med. 2008 Mar;5(3):513-23; quiz 524-5. doi: 10.1111/j.1743-6109.2007.00761.x.

  PMID: 18304280 BACKGROUND

• Onghena P, Van Houdenhove B. Antidepressant-induced analgesia in chronic non-malignant pain: a meta-analysis of 39 placebo-controlled studies. Pain. 1992 May;49(2):205-219. doi: 10.1016/0304-3959(92)90144-Z.

  PMID: 1535121 BACKGROUND

• Bornstein J, Tuma R, Farajun Y, Azran A, Zarfati D. Topical nifedipine for the treatment of localized provoked vulvodynia: a placebo-controlled study. J Pain. 2010 Dec;11(12):1403-9. doi: 10.1016/j.jpain.2010.03.016. Epub 2010 May 26.

  PMID: 20537958 BACKGROUND

• Katsinelos P, Papaziogas B, Koutelidakis I, Paroutoglou G, Dimiropoulos S, Souparis A, Atmatzidis K. Topical 0.5% nifedipine vs. lateral internal sphincterotomy for the treatment of chronic anal fissure: long-term follow-up. Int J Colorectal Dis. 2006 Mar;21(2):179-83. doi: 10.1007/s00384-005-0766-x. Epub 2005 Aug 10.

  PMID: 16091912 BACKGROUND

• Nelson R. Non surgical therapy for anal fissure. Cochrane Database Syst Rev. 2006 Oct 18;(4):CD003431. doi: 10.1002/14651858.CD003431.pub2.

  PMID: 17054170 BACKGROUND

• Hundley AF, Wu JM, Visco AG. A comparison of perineometer to brink score for assessment of pelvic floor muscle strength. Am J Obstet Gynecol. 2005 May;192(5):1583-91. doi: 10.1016/j.ajog.2004.11.015.

  PMID: 15902162 BACKGROUND

MeSH Terms

Conditions

Levator syndrome; Pelvic Pain; Vaginismus; Myofascial Pain Syndromes

Interventions

Nifedipine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Mental Disorders; Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Daniel Biller, MD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 20, 2012
• First Posted: April 26, 2012
• Study Start: July 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: May 22, 2014

Record last verified: 2014-05

Locations

US (1)