District of Columbia
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
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.
- Patients should be 18 years of age or older and capable of providing informed consent
indicating awareness of the investigational nature of this trial.
- History of chronic anorectal pain from levator ani spasm three or more months in
- Pain involves only the anorectum, and is part of one of the established variants of
levator ani syndrome including spasm, coccygodynia, proctalgia fugax.
- Written informed consent must be obtained from each patient prior to entering the
- Female patients will not be pregnant. Exclusion of the possibility of pregnancy by
HCG testing (urine or serum) or by history (tubal ligation, hysterectomy, or
menopause) is required prior to inclusion in the study.
- Patients should be willing to be followed within the military healthcare system
during the course of study treatment and follow-up. Follow-up at other military
facilities is acceptable.
- Ability to follow study instructions and likely to complete all required visits.
- Patients with current participation in another clinical investigation of a medical
device or a drug the requirements of which may preclude complete involvement in this
- Active or previous (within 60 days prior to the study screening visit) chemotherapy
- Active or previous (within 60 days prior to the study screening visit) radiation
- Physical or mental disability or geographical concerns (residence not within
reasonable travel distance) that would hamper compliance with required study visits
- The Investigator believes that the subject will be unwilling or unable to comply with
study protocol requirements
- Patients < 18 years of age
- Incapable of providing informed consent
- Subject has chronic (>3 months) vaginal pain not related to levator spasm
- Patients who are pregnant.
- Patients unwilling, or unable, to be followed within the military healthcare system
during the course of study treatment and follow-up.
- Documented urinary tract infection
- Genitourinary (GU) or anorectal malignancy
- Undergoing Botulinum toxin injection therapy or biofeedback therapy at the time of
- Known allergy or sensitivity to any study medication (Botulinum toxin, lidocaine)
- History of infection with Human Immunodeficiency Virus
- History of immunodeficiency disorders
- Patients taking antibiotics at the time of study enrollment
- Diagnosis of myasthenia gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral
Sclerosis, spinal cord injury or any other significant disease which might interfere
with neuromuscular transmission.
- Concurrent use of agents that interfere with neuromuscular transmission
- Profound atrophy or excessive weakness on physical examination of the muscles to be
injected with associated fecal incontinence
- Infection at the injection site
- Is overtly psychotic or suicidal.
- Anismus (inability to empty the rectum adequately during defecation) not associated
with painful levator ani muscles
- History of anorectal or low pelvic surgery within the last year