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Pelvic Floor Muscle Training and Biofeedback or Standard Therapy in Men Who Have Undergone Radical Prostatectomy or Transurethral Resection of the Prostate
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), December 2008
First Received: March 7, 2008   Last Updated: July 14, 2009   History of Changes
Sponsor: Aberdeen Royal Infirmary
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00632138
  Purpose

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 Intervention Phase
Precancerous/Nonmalignant Condition
Prostate Cancer
Psychosocial Effects of Cancer and Its Treatment
Sexual Dysfunction and Infertility
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 III

Study Type: Interventional
Study Design: Supportive Care, Randomized, Active Control
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]

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Subjective report of urinary continence at 12 months [ Designated as safety issue: No ]
  • Incremental cost per quality-adjusted year [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subjective report of continence or improvement of urinary incontinence at 3, 6, and 9 months after randomization and improvement at 12 months [ Designated as safety issue: No ]
  • Objective report of the number of incontinent episodes in the previous week from the urinary diary [ Designated as safety issue: No ]
  • Duration of incontinence based on time of resolution relative to time of operation and randomization [ Designated as safety issue: No ]
  • Use of absorbent pads, penile collecting sheath, bladder catheter, or bed/chair pads [ Designated as safety issue: No ]
  • Number and type of incontinence products used [ Designated as safety issue: No ]
  • Co-existence, cure or development of urgency, or urge incontinence [ Designated as safety issue: No ]
  • Urinary frequency [ Designated as safety issue: No ]
  • Nocturia [ Designated as safety issue: No ]
  • Fecal incontinence (passive or urge) [ Designated as safety issue: No ]
  • Other bowel dysfunction (i.e., urgency, constipation, or other bowel diseases) [ Designated as safety issue: No ]
  • Sexual function at 12 months including information about erection, ejaculation, retrograde ejaculation, pain, change in sex life, and reason for change [ Designated as safety issue: No ]
  • Incontinence-specific quality of life outcome measure using the 10-point scale and ICI questionnaire [ Designated as safety issue: No ]
  • General health measures [ Designated as safety issue: No ]
  • Need for alternative management for incontinence (e.g., surgery or drugs) [ Designated as safety issue: No ]
  • Use of GP, nurse, consultant urologist, or physiotherapist [ Designated as safety issue: No ]
  • Visits to GP [ Designated as safety issue: No ]
  • Visits to practice nurse [ Designated as safety issue: No ]
  • Use of pelvic floor muscle training [ Designated as safety issue: No ]
  • Lifestyle changes (i.e., weight, constipation, lifting, coughing, or exercise) [ Designated as safety issue: No ]
  • Patient costs (e.g., self care [e.g., pads or laundry], travel to health services, or sick leave) [ Designated as safety issue: No ]
  • Cost of conservative trial treatment [ Designated as safety issue: No ]
  • 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) [ Designated as safety issue: No ]
  • Other measures of cost-effectiveness (e.g., incremental cost per additional man continent at 12 months) [ Designated as safety issue: No ]

Estimated Enrollment: 800
Study Start Date: January 2005
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
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

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00632138

Locations
United Kingdom, England
Airedale General Hospital Recruiting
Keighley, England, United Kingdom, BD20 6TD
Contact: Contact Person     44-153-565-2511        
Berkshire Cancer Centre at Royal Berkshire Hospital Recruiting
Reading, England, United Kingdom, RG1 5AN
Contact: Contact Person     44-118-322-8948        
Bristol Royal Infirmary Recruiting
Bristol, England, United Kingdom, BS2 8HW
Contact: Contact Person     44-117-980-4118        
Freeman Hospital Recruiting
Newcastle-Upon-Tyne, England, United Kingdom, NE7 7DN
Contact: Contact Person     44-191-233-6161        
Hillingdon Hospital Recruiting
Uxbridge, England, United Kingdom, UB8 3NN
Contact: Contact Person     44-189-523-8282        
Hope Hospital Recruiting
Salford, England, United Kingdom, M6 8HD
Contact: Contact Person     44-161-789-7373        
Ipswich Hospital Recruiting
Ipswich, England, United Kingdom, IP4 5PD
Contact: Contact Person     44-147-370-3689        
James Cook University Hospital Recruiting
Middlesbrough, England, United Kingdom, TS4 3BW
Contact: Contact Person     44-164-285-4712        
King George Hospital Recruiting
Ilford, Essex, England, United Kingdom, IG3 8YB
Contact: Contact Person     44-208-8983-8000        
Royal Bolton Hospital Recruiting
Farnworth, England, United Kingdom, BL4 0JR
Contact: Contact Person     44-120-439-0445        
Lister Hospital Recruiting
Stevenage, England, United Kingdom, SG1 4AB
Contact: Contact Person     44-143-831-4333        
Macclesfield District General Hospital Recruiting
Macclesfield, England, United Kingdom, SK10 3BL
Contact: Contact Person     44-161-419-4299        
Mid Cheshire Hospitals Trust- Leighton Hopsital Recruiting
Crewe, England, United Kingdom, CW1 4QJ
Contact: Contact Person     44-127-061-2395        
New Cross Hospital Recruiting
Wolverhampton, England, United Kingdom, WV10 0QP
Contact: Contact Person     44-190-264-2822        
Norfolk and Norwich University Hospital Recruiting
Norwich, England, United Kingdom, NR4 7UY
Contact: Contact Person     44-160-328-6774        
Nottingham City Hospital NHS Trust Recruiting
Nottingham, England, United Kingdom, NG5 1PB
Contact: Contact Person     44-115-969-1169        
Queens Hospital Recruiting
Romford, England, United Kingdom, RM3 0BE
Contact: Contact Person     44-1708-345-533        
Leeds Cancer Centre at St. James's University Hospital Recruiting
Leeds, England, United Kingdom, LS9 7TF
Contact: Contact Person     44-113-206-6994        
Royal Hallamshire Hospital Recruiting
Sheffield, England, United Kingdom, S1O 2JF
Contact: Contact Person     44-114-226-1369        
Southmead Hospital Recruiting
Bristol, England, United Kingdom, BS10 5NB
Contact: Contact Person     44-117-950-5050        
St. Mary's Hospital Recruiting
London, England, United Kingdom, W2 1NY
Contact: Contact Person     44-207-886-1006        
Stepping Hill Hospital Recruiting
Stockport, England, United Kingdom, SK2 7JE
Contact: Contact Person     44-161-419-4299        
Tameside General Hospital Recruiting
Ashton-Under-Lyne, England, United Kingdom, OL6 9RW
Contact: Contact Person     44-161-419-4299        
Taunton and Somerset Hospital Recruiting
Taunton, England, United Kingdom, TA1 5DA
Contact: Contact Person     44-182-334-2111        
Yeovil District Hospital Recruiting
Yeovil, England, United Kingdom, BA21 4AT
Contact: Contact Person     44-193-538-4227        
United Kingdom, Scotland
Aberdeen Royal Infirmary Recruiting
Aberdeen, Scotland, United Kingdom, AB25 2ZN
Contact: Contact Person     44-122-455-0516     claire.cochran@abdn.ac.uk    
Ayr Hospital Recruiting
Ayr, Scotland, United Kingdom, KA6 6DX
Contact: Contact Person     44-129-261-0555 ext. 4354        
Edinburgh Cancer Centre at Western General Hospital Recruiting
Edinburgh, Scotland, United Kingdom, EH4 2XU
Contact: Contact Person     44-777-034-0960        
Falkirk & District Royal Infirmary Recruiting
Falkirk, Scotland, United Kingdom, FK1 5QE
Contact: Contact Person     44-132-461-6026        
Inverclyde Royal Hospital Recruiting
Greenock, Scotland, United Kingdom, PA16 0XN
Contact: Contact Person     44-147-563-3777        
Morriston Hospital NHS Trust Recruiting
West Glamorgen, Scotland, United Kingdom, SA6 6NL
Contact: Contact Person     44-179-270-2222        
Ninewells Hospital Recruiting
Dundee, Scotland, United Kingdom, DD1 9SY
Contact: Contact Person     44-138-266-0111 ext. 35635        
Pinderfields General Hospital Recruiting
Wakefield, Scotland, United Kingdom, WF1 4DG
Contact: Contact Person     44-192-421-2416        
Queen Margaret Hospital - Dunfermline Recruiting
Dunfermline, Scotland, United Kingdom, KY12 0SU
Contact: Contact Person     44-138-362-3623 ext. 3143        
Raigmore Hospital Recruiting
Inverness, Scotland, United Kingdom, 1V2 3UJ
Contact: Contact Person     44-146-370-4000 ext. 5590        
Southern General Hospital Recruiting
Glasgow, Scotland, United Kingdom, G51 4TF
Contact: Contact Person     44-141-201-1511        
United Kingdom, Wales
University Hospital of Wales Recruiting
Cardiff, Wales, United Kingdom, CF14 4XW
Contact: Contact Person     44-292-074-5094        
Sponsors and Collaborators
Aberdeen Royal Infirmary
Investigators
Study Chair: Cathryn Glazener, MD Aberdeen Royal Infirmary
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000586420, ABROIN-MAPS, ISRCTN87696430
Study First Received: March 7, 2008
Last Updated: July 14, 2009
ClinicalTrials.gov Identifier: NCT00632138     History of Changes
Health Authority: Unspecified

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

Additional relevant MeSH terms:
Infertility
Prostatic Diseases
Precancerous Conditions
Genital Neoplasms, Male
Urination Disorders
Urogenital Neoplasms
Genital Diseases, Male
Genital Diseases, Female
Urological Manifestations
Signs and Symptoms
Neoplasms
Neoplasms by Site
Urologic Diseases
Urinary Incontinence
Prostatic Neoplasms

ClinicalTrials.gov processed this record on November 05, 2009