MAPS (Men After Prostate Surgery) : Conservative Treatment for Men With Urinary Incontinence After Prostate Surgery; Multicentre Randomised Controlled Trial of Pelvic Floor Muscle Training and Biofeedback [MAPS]
- To establish whether conservative physical treatment delivered personally by a trained
health professional results in better urinary and other outcomes compared with standard
management in men who are incontinence after prostate surgery.
OUTLINE: This is a multicenter study. Patients are stratified according to type of operation
(radical prostatectomy vs transurethral resection of prostate). Patients are randomized to 1
of 2 treatment arms.
- Arm I (intervention group): At 6 weeks after surgery, patients undergo an assessment of
their symptoms by a physiotherapist or continence nurse. All patients are taught pelvic
floor muscle training and men with urgency or urge incontinence are also taught bladder
training. Pelvic floor training consists of 3 maximum pelvic floor contractions in 3
positions (standing, sitting, and lying down) twice a day, lifting of the pelvic floor
while walking, tightening of the pelvic muscles before activities, and tightening of
the pelvic muscles after urinating to squeeze out any last drops. The strength of the
pelvic floor contractions is monitored by biofeedback involving digital anal assessment
and relaying the information back to men in order that they know when they are
performing contractions correctly and to inform them when they are increasing the
strength or duration of their contractions. Therapists may use machine-mediated
biofeedback with an anal biofeedback probe at their discretion in addition to digital
anal assessment. Bladder training consists of gradually delaying urination by pelvic
floor muscle contraction and distracting activities to teach the bladder to hold
increasing volumes of urine. Patients also receive a customized Pelvic Floor Exercise
Booklet describing pelvic floor muscle training in addition to a customized Lifestyle
Advice Booklet giving general lifestyle advice. Patients have reinforcement sessions at
approximately 2, 6, and 12 weeks after the first appointment.
- Arm II (control group): Patients receive a customized Lifestyle Advice Booklet
containing supportive lifestyle advice only (without reference to pelvic floor muscle
training) by mail following randomization. Patients do not receive formal assessment or
treatment but will be able to access usual care and routine NHS services if they feel
they need help, including written advice if this is part of routine hospital care.
All patients keep a urinary diary at 3, 6, 9, and 12 months that includes frequency of
urination (day and night), daily episodes of incontinence and quantity of loss, daily use of
pads, and the need to change clothing or bedding. A Health Care Utilization Questionnaire
will be obtained at 3 and 9 months. Additional questionnaires are obtained at baseline and 6
and 12 months.
The use of NHS services, pads, and practice of pelvic floor muscle training is documented in
both groups using information from questionnaires and Urinary Diaries.
Six months after the last patient has been recruited, a check for Scottish men only is
performed to compare self-reported operations, diagnoses, and hospital admissions with
centrally collected data to validate a proportion of the data.
After completion of study treatment, patients are followed at 6 and 12 months.
Allocation: Randomized, Primary Purpose: Supportive Care
Subjective report of urinary continence at 12 months
Cathryn Glazener, MD
Aberdeen Royal Infirmary