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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00632138
First received: March 7, 2008
Last updated: August 6, 2013
Last verified: December 2008
  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
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

Study Type: Interventional
Study Design: 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]

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
Study Completion Date: July 2011
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00632138

Locations
United Kingdom
Tameside General Hospital
Ashton-Under-Lyne, England, United Kingdom, OL6 9RW
Bristol Royal Infirmary
Bristol, England, United Kingdom, BS2 8HW
Southmead Hospital
Bristol, England, United Kingdom, BS10 5NB
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
Investigators
Study Chair: Cathryn Glazener, MD Aberdeen Royal Infirmary
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00632138     History of Changes
Obsolete Identifiers: NCT00237029
Other Study ID Numbers: ABROIN-MAPS, CDR0000586420, ISRCTN87696430
Study First Received: March 7, 2008
Last Updated: August 6, 2013
Health Authority: Unspecified

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 Diseases, Male
Genital Neoplasms, Male
Lower Urinary Tract Symptoms
Neoplasms
Neoplasms by Site
Prostatic Diseases
Signs and Symptoms
Urination Disorders
Urogenital Neoplasms
Urologic Diseases
Urological Manifestations

ClinicalTrials.gov processed this record on October 23, 2014