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

NCT00632138 | Completed Phase 3

• 3 other identifiers: ABROIN-MAPSCDR0000586420ISRCTN87696430
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 37

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.

Conditions

Nonmalignant Neoplasm; Prostate Cancer; Psychosocial Effects of Cancer and Its Treatment; Sexual Dysfunction; Urinary Incontinence

Keywords

sexual dysfunction; psychosocial effects of cancer and its treatment; prostate cancer; benign prostatic hyperplasia; urinary incontinence

Outcome Measures

Primary Outcomes (2)

• Subjective report of urinary continence at 12 months

• Incremental cost per quality-adjusted year

Secondary Outcomes (23)

• 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

Interventions

exercise intervention BEHAVIORAL

questionnaire administration OTHER

biofeedback PROCEDURE

management of therapy complications PROCEDURE

psychosocial assessment and care PROCEDURE

quality-of-life assessment PROCEDURE

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Aberdeen Royal Infirmary: lead

Study Sites (37)

Tameside General Hospital

Ashton-under-Lyne, England, OL6 9RW, United Kingdom

Location

Southmead Hospital

Bristol, England, BS10 5NB, United Kingdom

Location

Bristol Royal Infirmary

Bristol, England, BS2 8HW, United Kingdom

Location

Mid Cheshire Hospitals Trust- Leighton Hopsital

Crewe, England, CW1 4QJ, United Kingdom

Location

Royal Bolton Hospital

Farnworth, England, BL4 0JR, United Kingdom

Location

King George Hospital

Ilford, Essex, England, IG3 8YB, United Kingdom

Location

Ipswich Hospital

Ipswich, England, IP4 5PD, United Kingdom

Location

Airedale General Hospital

Keighley, England, BD20 6TD, United Kingdom

Location

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

Location

St. Mary's Hospital

London, England, W2 1NY, United Kingdom

Location

Macclesfield District General Hospital

Macclesfield, England, SK10 3BL, United Kingdom

Location

James Cook University Hospital

Middlesbrough, England, TS4 3BW, United Kingdom

Location

Freeman Hospital

Newcastle upon Tyne, England, NE7 7DN, United Kingdom

Location

Norfolk and Norwich University Hospital

Norwich, England, NR4 7UY, United Kingdom

Location

Nottingham City Hospital

Nottingham, England, NG5 1PB, United Kingdom

Location

Berkshire Cancer Centre at Royal Berkshire Hospital

Reading, England, RG1 5AN, United Kingdom

Location

Queens Hospital

Romford, England, RM3 0BE, United Kingdom

Location

Hope Hospital

Salford, England, M6 8HD, United Kingdom

Location

Royal Hallamshire Hospital

Sheffield, England, S1O 2JF, United Kingdom

Location

Lister Hospital

Stevenage, England, SG1 4AB, United Kingdom

Location

Stepping Hill Hospital

Stockport, England, SK2 7JE, United Kingdom

Location

Taunton and Somerset Hospital

Taunton, England, TA1 5DA, United Kingdom

Location

Hillingdon Hospital

Uxbridge, England, UB8 3NN, United Kingdom

Location

New Cross Hospital

Wolverhampton, England, WV10 0QP, United Kingdom

Location

Yeovil District Hospital

Yeovil, England, BA21 4AT, United Kingdom

Location

Aberdeen Royal Infirmary

Aberdeen, Scotland, AB25 2ZN, United Kingdom

Location

Ayr Hospital

Ayr, Scotland, KA6 6DX, United Kingdom

Location

Ninewells Hospital

Dundee, Scotland, DD1 9SY, United Kingdom

Location

Queen Margaret Hospital - Dunfermline

Dunfermline, Scotland, KY12 0SU, United Kingdom

Location

Edinburgh Cancer Centre at Western General Hospital

Edinburgh, Scotland, EH4 2XU, United Kingdom

Location

Falkirk and District Royal Infirmary

Falkirk, Scotland, FK1 5QE, United Kingdom

Location

Southern General Hospital

Glasgow, Scotland, G51 4TF, United Kingdom

Location

Inverclyde Royal Hospital

Greenock, Scotland, PA16 0XN, United Kingdom

Location

Raigmore Hospital

Inverness, Scotland, 1V2 3UJ, United Kingdom

Location

Pinderfields General Hospital

Wakefield, Scotland, WF1 4DG, United Kingdom

Location

Morriston Hospital NHS Trust

West Glamorgen, Scotland, SA6 6NL, United Kingdom

Location

University Hospital of Wales

Cardiff, Wales, CF14 4XW, United Kingdom

Location

Related Publications (1)

• Johnson EE, Mamoulakis C, Stoniute A, Omar MI, Sinha S. Conservative interventions for managing urinary incontinence after prostate surgery. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD014799. doi: 10.1002/14651858.CD014799.pub2.

  PMID: 37070660 DERIVED

MeSH Terms

Conditions

Neoplasms; Prostatic Neoplasms; Sexual Dysfunction, Physiological; Urinary Incontinence; Prostatic Hyperplasia

Interventions

Biofeedback, Psychology; Psychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological; Rehabilitation; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Cathryn Glazener, MD

  Aberdeen Royal Infirmary

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: SUPPORTIVE CARE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 7, 2008
• First Posted: March 10, 2008
• Study Start: January 1, 2005
• Primary Completion: December 1, 2008
• Study Completion: July 1, 2011
• Last Updated: August 7, 2013

Record last verified: 2008-12

Locations

GB (37)