Prostate Cancer, Urinary Incontinence
Conditions
Brief summary
Objectives: Primary: Comparison of proportion of patient achieving continence between the four arms at 6 months. Secondary: * Comparison of time to achieve continence between the four arms. * Comparison of urinary symptoms and quality of life improvement between the four arms. * Assessment of adverse events in Duloxetine arms. Primary outcome/ time frame: Proportion of patient achieving continence at 6 months. Continence is defined as using no pador only security pad. Secondary outcome: * time to achieve continence * Quality of life tested in relation to incontinence according to Visual Analog Scale (VAS) and King's Health Questionnaire (KQH). * Urinary symptoms measured with International Prostate Symptom Score (IPSS). No. of subjects entered: 300 patients informed and included, 240 patients will be randomized. Statistical methods * Proportion of patients who achieve continence and time to achieve continence will be compared between the four arms. * Comparison of quality of life outcomes between the four arms * Comparison of clinical variables that can affect the primary/secondary outcome - univariate and multivariate analysis (ITT).
Interventions
DRUGDuloxetine
Duloxetine 60mg OD for 3 months
BEHAVIORALPelvic Floor Muscle Training
PMFT weekly for 3 months
Sponsors
Institut Mutualiste Montsouris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
Inclusion criteria
1\. All consecutive patients undergoing Robotic Assisted Radical Prostatectomy for clinically organ confined prostate cancer
Exclusion criteria
1. Prior urethral, bladder or prostate surgery 2. Pelvic radiotherapy. 3. Overactive bladder 4. Known neurological disease associated to LUTS 5. Hepatic impairment with hepatic insufficiency. 6. Severe renal impairment (creatinine clearance \< 30ml/min) 7. Hypersensitivity to duloxetine 8. Uncontrolled hypertension 9. Narrow angle glaucoma Post-operative criteria: 10. Post-void residual urine volume \> 100ml measured 15 days after the RARP
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urinary continence proportion | 6 months | Proportion of patient achieving continence at 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Urinary continence time | 6 months | time to achieve continence |
| Urinary quality of life | 6 months | Quality of life tested in relation to incontinence using questionnaire at 6 months |
Countries
France
Contacts
Primary ContactRafael Sanchez-Salas, MD
Outcome results
None listed