Clinical trial · Interventional
Prospective RCT on Post Prostatectomy Urine Leak
A Prospective Randomized Controlled Study Comparing the Efficacy of Pelvic Floor Muscle Training and Oral Duloxetine in the Recovery of Continence After Robotic Assisted Radical Prostatectomy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 pad"or "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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Urinary Incontinence | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Duloxetine | Drug | — | UNRESOLVED |
| Pelvic Floor Muscle Training | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- NO_INTERVENTION
- label
- Control
- description
- Keigel's exercise
- type
- ACTIVE_COMPARATOR
- label
- Duloxetine
- description
- Duloxetine 60mg for 3 months
- interventionNames
- Drug: Duloxetine
- type
- ACTIVE_COMPARATOR
- label
- Duloxetine + PMFT
- description
- Duloxetine 60mg for 3 months PMFT weekly for 3 months
- interventionNames
- Drug: Duloxetine
- Behavioral: Pelvic Floor Muscle Training
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
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
References
Publications (0)
Data not yet available