Clinical Trial: Comparison of Biofeedback vs. Botox Injection to Treat Levator Ani Syndrome
Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Comparison of Biofeedback Therapy and Botulinum Toxin Type A Injections for Treatment of Painful Levator Ani Syndrome in Women: A Randomized, Prospective Trial
Brief Summary:
Purpose: To assess whether EMG directed biofeedback therapy or Botulinum toxin type A injection of the levator ani muscles has any effect on pain from the levator ani syndrome, and, in addition, to what extent either treatment is superior to the other in terms of anorectal physiologic measurements, and quality of life.
Study Design: Randomized, prospective, unblinded double-armed study with crossover.
Methodology: Female subjects, aged 18 and over, with painful levator ani muscle spasm for at least one month duration will be randomized to receive either biofeedback therapy or Botulinum toxin type A injection. After randomization they will all undergo visual analog pain scoring, anorectal manometry, colonoscopy (if clinically indicated), and self-reported SF-36 quality of life measurement. Each patient will also complete numerical pain scale scoring, an SF-36, and a satisfaction questionnaire at each treatment visit and follow-up visit. Patients will submit these by mail. Identification numbers will be assigned to each subject for use on the SF-36 and Satisfaction Questionnaires throughout the study. Subjects will again undergo anorectal manometry at the end of their treatment arms. In the biofeedback arm patients will be treated biweekly for up to eight treatments and be provided exercises to practice at home based on their muscle function noted during the biofeedback training session. Subjects will keep a treatment diary of the exercises they do at home to help ensure compliance with the protocol. In the Botulinum toxin injection arm patients will be treated with scheduled injections of the levator ani muscles every six weeks for up to three total injections of 100U each. These injections will be directed to the painful areas of the levator muscles as guided by physical exam and EMG measurements. Should any patient fail t
Detailed Summary:
Sponsor: Walter Reed Army Medical Center
Current Primary Outcome: Pain reduction from treatment with either Biofeedback, Botox injection, or both [ Time Frame: Two years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Anorectal physiologic changes - increase or decrease in anal sphincter pressures [ Time Frame: Two years ]
- Overall patient satisfaction [ Time Frame: Two years ]
- Patient quality of life [ Time Frame: Two years ]
Original Secondary Outcome: Same as current
Information By: Walter Reed Army Medical Center
Dates:
Date Received: November 26, 2007
Date Started: August 2007
Date Completion: August 2009
Last Updated: November 26, 2007
Last Verified: November 2007
