Urinary incontinence Urological and Genital Diseases Unspecified urinary incontinence
Conditions
Interventions
Active Intervention:
Pelvic floor muscle training and lifestyle advice with selective biofeedback (which may be digital or machine-mediated) with or without bladder training. It consis
Sponsors
University of Aberdeen (UK)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Men (no age limits) who have urinary incontinence after prostate surgery (incontinence defined as a response indicating a loss of urine to either of two questions in the screening questionnaire: (how often do you leak urine? and how much urine do you leak?) 2. Informed consent 3. Ability to comply with intervention
Exclusion criteria
Exclusion criteria: 1. Radiotherapy planned or given during the first three months after surgery for men with prostate cancer 2. Endoscopic resection of prostate carried out as palliation for outflow obstruction in advanced prostate cancer 3. Multiple sclerosis or Parkinson's disease 4. Inability to complete study questionnaires
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Primary clinical outcome: subjective report of urinary continence at 12 months 2. Primary measure of cost effectiveness: incremental cost per quality-adjusted life year | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical 1. Subjective report of continence or improvement of urinary incontinence at six months after randomisation, and improvement at 12 months 2. Number of incontinent episodes in previous week (objective, from diary) 3. Duration of incontinence (based on time of resolution relative to time of operation and randomisation) 4. Use of absorbent pads, penile collecting sheath, bladder catheter or bed/chair pads 5. Number and type of incontinence products used 6. Co-existence, cure or development of urgency or urge incontinence 7. Urinary frequency 8. Nocturia 9. Faecal incontinence (passive or urge) 10. Other bowel dysfunction (urgency, constipation, other bowel diseases) 11. Sexual function at 12 months (including information about erection, ejaculation, retrograde ejaculation, pain, change in sex life and reason for change) Quality of life 1. Incontinence-specific quality of life outcome measure (10-point scale, International Consultation on Incontinence [ICI] questionnaire, Incontinence Quality of Life [I-QOL] questionnaire) 2. General health measures (SF-12® Health Survey, Euroqol EQ-5D) Use of health services for urinary incontinence 1. Need for alternative management for incontinence (e.g., surgery, drugs) 2. Use of GP, nurse, consultant urologist, physiotherapist Other use of health services 1. Visits to GP 2. Visits to practice nurse Effects of interventions 1. Use of pelvic floor muscle training (PFMT) 2. Lifestyle changes (weight, constipation, lifting, coughing, exercise) Economic measures 1. Patient costs (e.g., self care [e.g., pads, laundry], travel to he | — |
Countries
Scotland, United Kingdom
Outcome results
None listed