Pelvic Floor Muscle Training and Biofeedback or Standard Therapy in Men Who Have Undergone Radical Prostatectomy or Transurethral Resection of the Prostate

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00632138
Recruitment Status : Completed
First Posted : March 10, 2008
Last Update Posted : August 7, 2013
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Nonmalignant Neoplasm Prostate Cancer Psychosocial Effects of Cancer and Its Treatment Sexual Dysfunction Urinary Incontinence Behavioral: exercise intervention Other: questionnaire administration Procedure: biofeedback Procedure: management of therapy complications Procedure: psychosocial assessment and care Procedure: quality-of-life assessment Phase 3

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Primary Purpose: Supportive Care
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 Start Date : January 2005
Actual Primary Completion Date : December 2008
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Subjective report of urinary continence at 12 months
  2. Incremental cost per quality-adjusted year

Secondary Outcome Measures :
  1. Subjective report of continence or improvement of urinary incontinence at 3, 6, and 9 months after randomization and improvement at 12 months
  2. Objective report of the number of incontinent episodes in the previous week from the urinary diary
  3. Duration of incontinence based on time of resolution relative to time of operation and randomization
  4. Use of absorbent pads, penile collecting sheath, bladder catheter, or bed/chair pads
  5. Number and type of incontinence products used
  6. Co-existence, cure or development of urgency, or urge incontinence
  7. Urinary frequency
  8. Nocturia
  9. Fecal incontinence (passive or urge)
  10. Other bowel dysfunction (i.e., urgency, constipation, or other bowel diseases)
  11. Sexual function at 12 months including information about erection, ejaculation, retrograde ejaculation, pain, change in sex life, and reason for change
  12. Incontinence-specific quality of life outcome measure using the 10-point scale and ICI questionnaire
  13. General health measures
  14. Need for alternative management for incontinence (e.g., surgery or drugs)
  15. Use of GP, nurse, consultant urologist, or physiotherapist
  16. Visits to GP
  17. Visits to practice nurse
  18. Use of pelvic floor muscle training
  19. Lifestyle changes (i.e., weight, constipation, lifting, coughing, or exercise)
  20. Patient costs (e.g., self care [e.g., pads or laundry], travel to health services, or sick leave)
  21. Cost of conservative trial treatment
  22. 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)
  23. Other measures of cost-effectiveness (e.g., incremental cost per additional man continent at 12 months)

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • 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


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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00632138

United Kingdom
Tameside General Hospital
Ashton-Under-Lyne, England, United Kingdom, OL6 9RW
Southmead Hospital
Bristol, England, United Kingdom, BS10 5NB
Bristol Royal Infirmary
Bristol, England, United Kingdom, BS2 8HW
Mid Cheshire Hospitals Trust- Leighton Hopsital
Crewe, England, United Kingdom, CW1 4QJ
Royal Bolton Hospital
Farnworth, England, United Kingdom, BL4 0JR
King George Hospital
Ilford, Essex, England, United Kingdom, IG3 8YB
Ipswich Hospital
Ipswich, England, United Kingdom, IP4 5PD
Airedale General Hospital
Keighley, England, United Kingdom, BD20 6TD
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom, LS9 7TF
St. Mary's Hospital
London, England, United Kingdom, W2 1NY
Macclesfield District General Hospital
Macclesfield, England, United Kingdom, SK10 3BL
James Cook University Hospital
Middlesbrough, England, United Kingdom, TS4 3BW
Freeman Hospital
Newcastle-Upon-Tyne, England, United Kingdom, NE7 7DN
Norfolk and Norwich University Hospital
Norwich, England, United Kingdom, NR4 7UY
Nottingham City Hospital
Nottingham, England, United Kingdom, NG5 1PB
Berkshire Cancer Centre at Royal Berkshire Hospital
Reading, England, United Kingdom, RG1 5AN
Queens Hospital
Romford, England, United Kingdom, RM3 0BE
Hope Hospital
Salford, England, United Kingdom, M6 8HD
Royal Hallamshire Hospital
Sheffield, England, United Kingdom, S1O 2JF
Lister Hospital
Stevenage, England, United Kingdom, SG1 4AB
Stepping Hill Hospital
Stockport, England, United Kingdom, SK2 7JE
Taunton and Somerset Hospital
Taunton, England, United Kingdom, TA1 5DA
Hillingdon Hospital
Uxbridge, England, United Kingdom, UB8 3NN
New Cross Hospital
Wolverhampton, England, United Kingdom, WV10 0QP
Yeovil District Hospital
Yeovil, England, United Kingdom, BA21 4AT
Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom, AB25 2ZN
Ayr Hospital
Ayr, Scotland, United Kingdom, KA6 6DX
Ninewells Hospital
Dundee, Scotland, United Kingdom, DD1 9SY
Queen Margaret Hospital - Dunfermline
Dunfermline, Scotland, United Kingdom, KY12 0SU
Edinburgh Cancer Centre at Western General Hospital
Edinburgh, Scotland, United Kingdom, EH4 2XU
Falkirk and District Royal Infirmary
Falkirk, Scotland, United Kingdom, FK1 5QE
Southern General Hospital
Glasgow, Scotland, United Kingdom, G51 4TF
Inverclyde Royal Hospital
Greenock, Scotland, United Kingdom, PA16 0XN
Raigmore Hospital
Inverness, Scotland, United Kingdom, 1V2 3UJ
Pinderfields General Hospital
Wakefield, Scotland, United Kingdom, WF1 4DG
Morriston Hospital NHS Trust
West Glamorgen, Scotland, United Kingdom, SA6 6NL
University Hospital of Wales
Cardiff, Wales, United Kingdom, CF14 4XW
Sponsors and Collaborators
Aberdeen Royal Infirmary
Study Chair: Cathryn Glazener, MD Aberdeen Royal Infirmary Identifier: NCT00632138     History of Changes
Obsolete Identifiers: NCT00237029
Other Study ID Numbers: ABROIN-MAPS
CDR0000586420 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: March 10, 2008    Key Record Dates
Last Update Posted: August 7, 2013
Last Verified: December 2008

Keywords provided by National Cancer Institute (NCI):
sexual dysfunction
psychosocial effects of cancer and its treatment
prostate cancer
benign prostatic hyperplasia
urinary incontinence

Additional relevant MeSH terms:
Prostatic Neoplasms
Urinary Incontinence
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders