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Objectives:
Primary: Comparison of proportion of patient achieving continence between the four arms at 6 months.
Secondary:
Primary outcome/ time frame: Proportion of patient achieving continence at 6 months. Continence is defined as "using no pad"or "only security pad".
Secondary outcome:
No. of subjects entered: 300 patients informed and included, 240 patients will be randomized.
Statistical methods
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Keigel's exercise | |
| Duloxetine | Active Comparator | Duloxetine 60mg for 3 months |
|
| Duloxetine + PMFT | Active Comparator | Duloxetine 60mg for 3 months PMFT weekly for 3 months |
|
| Pelvic Floor Muscle Training | Active Comparator | PMFT weekly for 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duloxetine | Drug | Duloxetine 60mg OD for 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Urinary continence proportion | Proportion of patient achieving continence at 6 months | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary continence time | time to achieve continence | 6 months |
| Urinary quality of life | Quality of life tested in relation to incontinence using questionnaire at 6 months |
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Inclusion Criteria:
1. All consecutive patients undergoing Robotic Assisted Radical Prostatectomy for clinically organ confined prostate cancer
Exclusion Criteria:
Prior urethral, bladder or prostate surgery
Pelvic radiotherapy.
Overactive bladder
Known neurological disease associated to LUTS
Hepatic impairment with hepatic insufficiency.
Severe renal impairment (creatinine clearance < 30ml/min)
Hypersensitivity to duloxetine
Uncontrolled hypertension
Narrow angle glaucoma
Post-operative criteria:
Post-void residual urine volume > 100ml measured 15 days after the RARP
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rafael Sanchez-Salas, MD | Contact | 0156616617 | rafael.sanchez-salas@imm.fr |
| Name | Affiliation | Role |
|---|---|---|
| Rafael Sanchez-Salas, MD | Institute Mutualiste Montsouris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Mutualiste montsouris | Recruiting | Paris | 75014 | France |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000068736 | Duloxetine Hydrochloride |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Pelvic Floor Muscle Training | Behavioral | PMFT weekly for 3 months |
|
|
| 6 months |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006571 |
| Heterocyclic Compounds |