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

Prostate Cancer Clinical Trial

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]

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00632138
• Other study ID #: ABROIN-MAPS
• Secondary ID: CDR0000586420ISR
• Status: Completed
• Phase: Phase 3
• First received: March 7, 2008
• Last updated: August 6, 2013
• Start date: January 2005
• Est. completion date: July 2011

Study information

• Verified date: December 2008
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00237029

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: July 2011
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Nonmalignant Neoplasm
• Prostate Cancer
• Prostatic Neoplasms
• Psychosocial Effects of Cancer and Its Treatment
• Sexual Dysfunction
• Urinary Incontinence

Intervention

Behavioral:
• exercise intervention

Other:
• questionnaire administration

Procedure:
• biofeedback

• management of therapy complications

• psychosocial assessment and care

• quality-of-life assessment

Locations

Country	Name	City	State
United Kingdom	Aberdeen Royal Infirmary	Aberdeen	Scotland
United Kingdom	Tameside General Hospital	Ashton-Under-Lyne	England
United Kingdom	Ayr Hospital	Ayr	Scotland
United Kingdom	Bristol Royal Infirmary	Bristol	England
United Kingdom	Southmead Hospital	Bristol	England
United Kingdom	University Hospital of Wales	Cardiff	Wales
United Kingdom	Mid Cheshire Hospitals Trust- Leighton Hopsital	Crewe	England
United Kingdom	Ninewells Hospital	Dundee	Scotland
United Kingdom	Queen Margaret Hospital - Dunfermline	Dunfermline	Scotland
United Kingdom	Edinburgh Cancer Centre at Western General Hospital	Edinburgh	Scotland
United Kingdom	Falkirk and District Royal Infirmary	Falkirk	Scotland
United Kingdom	Royal Bolton Hospital	Farnworth	England
United Kingdom	Southern General Hospital	Glasgow	Scotland
United Kingdom	Inverclyde Royal Hospital	Greenock	Scotland
United Kingdom	King George Hospital	Ilford, Essex	England
United Kingdom	Raigmore Hospital	Inverness	Scotland
United Kingdom	Ipswich Hospital	Ipswich	England
United Kingdom	Airedale General Hospital	Keighley	England
United Kingdom	Leeds Cancer Centre at St. James's University Hospital	Leeds	England
United Kingdom	St. Mary's Hospital	London	England
United Kingdom	Macclesfield District General Hospital	Macclesfield	England
United Kingdom	James Cook University Hospital	Middlesbrough	England
United Kingdom	Freeman Hospital	Newcastle-Upon-Tyne	England
United Kingdom	Norfolk and Norwich University Hospital	Norwich	England
United Kingdom	Nottingham City Hospital	Nottingham	England
United Kingdom	Berkshire Cancer Centre at Royal Berkshire Hospital	Reading	England
United Kingdom	Queens Hospital	Romford	England
United Kingdom	Hope Hospital	Salford	England
United Kingdom	Royal Hallamshire Hospital	Sheffield	England
United Kingdom	Lister Hospital	Stevenage	England
United Kingdom	Stepping Hill Hospital	Stockport	England
United Kingdom	Taunton and Somerset Hospital	Taunton	England
United Kingdom	Hillingdon Hospital	Uxbridge	England
United Kingdom	Pinderfields General Hospital	Wakefield	Scotland
United Kingdom	Morriston Hospital NHS Trust	West Glamorgen	Scotland
United Kingdom	New Cross Hospital	Wolverhampton	England
United Kingdom	Yeovil District Hospital	Yeovil	England

Sponsors (1)

Lead Sponsor	Collaborator
Aberdeen Royal Infirmary

Country where clinical trial is conducted

United Kingdom, 

Outcome

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