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

Levator Ani Syndrome Clinical Trial

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?

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01586286
• Other study ID #: 111573
• Status: Withdrawn
• Phase: N/A
• First received: April 20, 2012
• Last updated: May 21, 2014
• Start date: July 2012
• Est. completion date: May 2014

Study information

• Verified date: May 2014
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Study Design

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

Related Conditions & MeSH terms

• Levator Ani Syndrome
• Myalgia

Intervention

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

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2005 Aug 10. — View Citation

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. — View Citation

Nelson R. Non surgical therapy for anal fissure. Cochrane Database Syst Rev. 2006 Oct 18;(4):CD003431. Review. Update in: Cochrane Database Syst Rev. 2012;2:CD003431. — View Citation

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):205-19. — View Citation

Reiter RC. A profile of women with chronic pelvic pain. Clin Obstet Gynecol. 1990 Mar;33(1):130-6. Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	Improvement in Hypertonic Pelvic Floor Muscles	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.	To be assessed at baseline and the following post-treatment intervals: 1, 2, 3, and 6 months	No