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

August 6, 2013 updated by: Aberdeen Royal Infirmary

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]

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

800

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Subjective report of urinary continence at 12 months
Incremental cost per quality-adjusted year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aberdeen Royal Infirmary

Investigators

  • Study Chair: Cathryn Glazener, MD, Aberdeen Royal Infirmary

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

March 7, 2008

First Submitted That Met QC Criteria

March 7, 2008

First Posted (Estimate)

March 10, 2008

Study Record Updates

Last Update Posted (Estimate)

August 7, 2013

Last Update Submitted That Met QC Criteria

August 6, 2013

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABROIN-MAPS
  • CDR0000586420 (Registry Identifier: PDQ (Physician Data Query))
  • ISRCTN87696430

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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