Prostate CancerPhase 3NCT02367404
Prospective RCT on Post Prostatectomy Urine Leak
A Phase 3 study testing Duloxetine and Pelvic Floor Muscle Training in people with Prostate Cancer and Urinary Incontinence, run by Institut Mutualiste Montsouris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer, Urinary Incontinence
- What is being tested?
- Duloxetine and Pelvic Floor Muscle Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteFrance
- Study dates
- May 2015to Jun 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1. All consecutive patients undergoing Robotic Assisted Radical Prostatectomy for clinically organ confined prostate cancer
Who cannot join
- 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)
Show all 11Show fewer
- Hypersensitivity to duloxetine
- Uncontrolled hypertension
- Narrow angle glaucoma
- Post-operative criteria:
- Post-void residual urine volume > 100ml measured 15 days after the RARP
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Institut Mutualiste montsouris
Paris, 75014
About this study
Official title: 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
Objectives:
Primary: Comparison of proportion of patient achieving continence between the four arms at 6 months.
Read more
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
- Prostate Cancer, Urinary Incontinence
- Being tested
- Duloxetine, Pelvic Floor Muscle Training
- Medical subject headings
- Prostatic Neoplasms, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuloxetineDrug
Also called Cymbalta
Duloxetine 60mg OD for 3 months
Pelvic Floor Muscle TrainingBehavioural
Also called Pelvic Physiotherqpy
PMFT weekly for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Keigel's exercise |
| Duloxetine | Active comparator | Duloxetine 60mg for 3 months Receives: Drug: Duloxetine |
| Duloxetine + PMFT | Active comparator | Duloxetine 60mg for 3 months PMFT weekly for 3 months Receives: Drug: Duloxetine; Behavioral: Pelvic Floor Muscle Training |
| Pelvic Floor Muscle Training | Active comparator | PMFT weekly for 3 months Receives: Behavioral: Pelvic Floor Muscle Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary continence proportion
Proportion of patient achieving continence at 6 months
Measured: 6 months
Secondary outcomes (2)
Urinary continence time
time to achieve continence
Measured: 6 months
Urinary quality of life
Quality of life tested in relation to incontinence using questionnaire at 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2015 (estimated)
- Study startMay 2015
- Primary completionFeb 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Mutualiste Montsouris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rafael Sanchez-Salas, MD, Principal investigator, Institute Mutualiste Montsouris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02367404
- Sponsor's protocol ID
- URO-01-2014
- Status last verified
- Sep 2016
- First submitted
- 13 Feb 2015
- Last updated
- 13 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02367404
- Acronym / sponsor ID
- URO-01-2014
- Conditions
- Prostate Cancer, Urinary Incontinence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Institut Mutualiste MontsourisUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 20 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Keigel's exercise |
| Duloxetine | Active comparator | Drug: DuloxetineDuloxetine 60mg for 3 months |
| Duloxetine + PMFT | Active comparator | Drug: Duloxetine, Behavioral: Pelvic Floor Muscle TrainingDuloxetine 60mg for 3 months PMFT weekly for 3 months |
| Pelvic Floor Muscle Training | Active comparator | Behavioral: Pelvic Floor Muscle TrainingPMFT weekly for 3 months |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 1. All consecutive patients undergoing Robotic Assisted Radical Prostatectomy for clinically organ confined prostate cancer
Key exclusion criteria (11 listed)
- Prior urethral, bladder or prostate surgery
- Pelvic radiotherapy.
- Overactive bladder
- Known neurological disease associated to LUTS
- Hepatic impairment with hepatic insufficiency.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DuloxetineAlso: CymbaltaDuloxetine 60mg OD for 3 months | Drug | Duloxetine, Duloxetine + PMFT |
| Pelvic Floor Muscle TrainingAlso: Pelvic PhysiotherqpyPMFT weekly for 3 months | Behavioural | Duloxetine + PMFT, Pelvic Floor Muscle Training |
Primary outcome
Urinary continence proportion
Time frame: 6 months
Proportion of patient achieving continence at 6 months
2 secondary outcomes
Urinary continence time
Time frame: 6 months
Urinary quality of life
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rafael Sanchez-Salas, MD principal investigator
Institute Mutualiste Montsouris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Duloxetine and Pelvic Floor Muscle Training in people with Prostate Cancer and Urinary Incontinence, run by Institut Mutualiste Montsouris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rafael Sanchez-Salas, MD (0156616617, rafael.sanchez-salas@imm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary continence proportion (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2016.