Levator Ani Syndrome With Pain and/or Constipation Symptoms. Clinical Trial
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
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 their initial randomized treatment assignment (failure defined as "very dissatisfied"
or "dissatisfied" on the satisfaction questionnaire), they will then be allowed to cross
over to the other study arm. In addition to numerical pain scale scoring, an SF-36
questionnaire and anorectal manometry will also be repeated at the time of crossover. We
intend to include all randomized patients in the final data analysis (according to their
originally assigned treatment arm), regardless of outcome or reason for dropout, thus making
this an "intent-to-treat" analysis.
Pivotal Study Definitions: The definition of adequate pain reduction, for the purposes of
data analysis, will be a reduction in a subject's mean pain score of two on a numerical pain
scale (0-10). Failure of either therapy will be defined as a response of "very dissatisfied"
or "dissatisfied" on the satisfaction questionnaire at the end of either biofeedback (eight
treatment visits) or Botulinum toxin (three injections) both before and after crossover.
Outcomes: We will determine the following for biofeedback therapy and Botulinum toxin type A
injection: mean pain reduction, any differences in anorectal physiologic measurements (such
as mean resting anal sphincter pressure), any changes in self-reported quality of life, and
overall patient satisfaction.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment