Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE3
240 participants
INTERVENTIONAL
2015-05-31
2017-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Pelvic Floor Muscle Training to Treat Urinary Incontinence After Radical Prostatectomy
NCT00239824
The Efficacy of Pre-operative Educational Pelvic Floor Intervention on Urinary Continence
NCT03714984
Effects of Urinary Bladder Hypertrophy on Urge Urine Incontinence After Radical Prostatectomy
NCT03061760
Physical Therapy for Men Undergoing Prostatectomy
NCT02558946
Urinary Incontinence After Radical Prostatectomy
NCT05625048
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control
Keigel's exercise
No interventions assigned to this group
Duloxetine
Duloxetine 60mg for 3 months
Duloxetine
Duloxetine 60mg OD for 3 months
Duloxetine + PMFT
Duloxetine 60mg for 3 months PMFT weekly for 3 months
Duloxetine
Duloxetine 60mg OD for 3 months
Pelvic Floor Muscle Training
PMFT weekly for 3 months
Pelvic Floor Muscle Training
PMFT weekly for 3 months
Pelvic Floor Muscle Training
PMFT weekly for 3 months
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Duloxetine
Duloxetine 60mg OD for 3 months
Pelvic Floor Muscle Training
PMFT weekly for 3 months
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
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
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Institut Mutualiste Montsouris
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Rafael Sanchez-Salas, MD
Role: PRINCIPAL_INVESTIGATOR
Institute Mutualiste Montsouris
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Institut Mutualiste montsouris
Paris, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
URO-01-2014
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.