Clinical trial NCT00632138: Pelvic Floor Muscle Training and Biofeedback or Standard Therapy in Men Who Have Undergone Radical Prostatectomy or Transurethral Resection of the Prostate
Official title: 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]
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Nonmalignant Neoplasm
Prostate Cancer
Psychosocial Effects of Cancer and Its Treatment
Sexual Dysfunction
Urinary Incontinence
Keywords: sexual dysfunction
psychosocial effects of cancer and its treatment
prostate cancer
benign prostatic hyperplasia
urinary incontinence
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2008-03-10
Enrollment: 800
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: SUPPORTIVE_CARE

Brief summary: RATIONALE: Personalized training by a health professional may improve urinary incontinence. It is not yet known whether pelvic floor muscle training and biofeedback are more effective than standard therapy in improving urinary continence after radical prostatectomy or transurethral resection of the prostate.

PURPOSE: This randomized phase III trial is studying pelvic floor muscle training and biofeedback to see how well it works compared with standard therapy in men who have undergone radical prostatectomy or transurethral resection.

Detailed description: OBJECTIVES:

* 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.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Men who have undergone a radical prostatectomy for prostate cancer or men who have undergone a transurethral resection of the prostate for benign prostatic hypertrophy
* Urinary incontinence at six weeks after prostate surgery

  * Incontinence is defined as a response on the screening questionnaire indicating a loss of urine including how often and how much

PATIENT CHARACTERISTICS:

* Able to comply with intervention
* Able to complete study questionnaires

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No referral for formal therapy (teaching of pelvic floor muscle training) due to prostate surgery
* No concurrent or planned radiotherapy during the first 3 months after surgery
* No palliative endoscopic resection of prostate due to outflow obstruction for advanced prostate cancer

Primary outcomes:
measure: Subjective report of urinary continence at 12 months
measure: Incremental cost per quality-adjusted year
Secondary outcomes:
measure: Subjective report of continence or improvement of urinary incontinence at 3, 6, and 9 months after randomization and improvement at 12 months
measure: Objective report of the number of incontinent episodes in the previous week from the urinary diary
measure: Duration of incontinence based on time of resolution relative to time of operation and randomization
measure: Use of absorbent pads, penile collecting sheath, bladder catheter, or bed/chair pads
measure: Number and type of incontinence products used
measure: Co-existence, cure or development of urgency, or urge incontinence
measure: Urinary frequency
measure: Nocturia
measure: Fecal incontinence (passive or urge)
measure: Other bowel dysfunction (i.e., urgency, constipation, or other bowel diseases)
measure: Sexual function at 12 months including information about erection, ejaculation, retrograde ejaculation, pain, change in sex life, and reason for change
measure: Incontinence-specific quality of life outcome measure using the 10-point scale and ICI questionnaire
measure: General health measures
measure: Need for alternative management for incontinence (e.g., surgery or drugs)
measure: Use of GP, nurse, consultant urologist, or physiotherapist
measure: Visits to GP
measure: Visits to practice nurse
measure: Use of pelvic floor muscle training
measure: Lifestyle changes (i.e., weight, constipation, lifting, coughing, or exercise)
measure: Patient costs (e.g., self care [e.g., pads or laundry], travel to health services, or sick leave)
measure: Cost of conservative trial treatment
measure: Cost of alternative or additional NHS treatments (e.g., pads, catheters, drugs [e.g., adrenergic agonists, anticholinergics, or oral medication for erectile dysfunction], hospital admissions, or further surgery)
measure: Other measures of cost-effectiveness (e.g., incremental cost per additional man continent at 12 months)
Other outcomes:
Locations:
city: Ashton-Under-Lyne
country: United Kingdom
facility: Tameside General Hospital
state: England
city: Bristol
country: United Kingdom
facility: Southmead Hospital
state: England
city: Bristol
country: United Kingdom
facility: Bristol Royal Infirmary
state: England
city: Crewe
country: United Kingdom
facility: Mid Cheshire Hospitals Trust- Leighton Hopsital
state: England
city: Farnworth
country: United Kingdom
facility: Royal Bolton Hospital
state: England
city: Ilford, Essex
country: United Kingdom
facility: King George Hospital
state: England
city: Ipswich
country: United Kingdom
facility: Ipswich Hospital
state: England
city: Keighley
country: United Kingdom
facility: Airedale General Hospital
state: England
city: Leeds
country: United Kingdom
facility: Leeds Cancer Centre at St. James's University Hospital
state: England
city: London
country: United Kingdom
facility: St. Mary's Hospital
state: England
city: Macclesfield
country: United Kingdom
facility: Macclesfield District General Hospital
state: England
city: Middlesbrough
country: United Kingdom
facility: James Cook University Hospital
state: England
city: Newcastle-Upon-Tyne
country: United Kingdom
facility: Freeman Hospital
state: England
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospital
state: England
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital
state: England
city: Reading
country: United Kingdom
facility: Berkshire Cancer Centre at Royal Berkshire Hospital
state: England
city: Romford
country: United Kingdom
facility: Queens Hospital
state: England
city: Salford
country: United Kingdom
facility: Hope Hospital
state: England
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital
state: England
city: Stevenage
country: United Kingdom
facility: Lister Hospital
state: England
city: Stockport
country: United Kingdom
facility: Stepping Hill Hospital
state: England
city: Taunton
country: United Kingdom
facility: Taunton and Somerset Hospital
state: England
city: Uxbridge
country: United Kingdom
facility: Hillingdon Hospital
state: England
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital
state: England
city: Yeovil
country: United Kingdom
facility: Yeovil District Hospital
state: England
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
state: Scotland
city: Ayr
country: United Kingdom
facility: Ayr Hospital
state: Scotland
city: Dundee
country: United Kingdom
facility: Ninewells Hospital
state: Scotland
city: Dunfermline
country: United Kingdom
facility: Queen Margaret Hospital - Dunfermline
state: Scotland
city: Edinburgh
country: United Kingdom
facility: Edinburgh Cancer Centre at Western General Hospital
state: Scotland
city: Falkirk
country: United Kingdom
facility: Falkirk and District Royal Infirmary
state: Scotland
city: Glasgow
country: United Kingdom
facility: Southern General Hospital
state: Scotland
city: Greenock
country: United Kingdom
facility: Inverclyde Royal Hospital
state: Scotland
city: Inverness
country: United Kingdom
facility: Raigmore Hospital
state: Scotland
city: Wakefield
country: United Kingdom
facility: Pinderfields General Hospital
state: Scotland
city: West Glamorgen
country: United Kingdom
facility: Morriston Hospital NHS Trust
state: Scotland
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales
state: Wales
Study officials:
affiliation: Aberdeen Royal Infirmary
name: Cathryn Glazener, MD
role: STUDY_CHAIR
References: