Prospective RCT on Post Prostatectomy Urine Leak

Phase 3

• Conditions: Prostate Cancer; Urinary Incontinence
• Interventions: Behavioral: Pelvic Floor Muscle Training; Drug: Duloxetine

• Registration Number: NCT02367404
• Lead Sponsor: Institut Mutualiste Montsouris

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 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-02-13
• Study First Submitted QC: 2015-02-19
• Study First Posted: 2015-02-20
• Study Start: 2015-05
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-12
• Last Update Posted: 2016-09-13
• Primary Completion: 2017-02
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pelvic Floor Muscle Training	Pelvic Floor Muscle Training	PMFT weekly for 3 months
Duloxetine + PMFT	Pelvic Floor Muscle Training	Duloxetine 60mg for 3 months PMFT weekly for 3 months
Duloxetine + PMFT	Duloxetine	Duloxetine 60mg for 3 months PMFT weekly for 3 months
Duloxetine	Duloxetine	Duloxetine 60mg for 3 months

Primary Outcome Measures

Name	Time	Method
Urinary continence proportion	6 months	Proportion of patient achieving continence at 6 months

Secondary Outcome Measures

Name	Time	Method
Urinary quality of life	6 months	Quality of life tested in relation to incontinence using questionnaire at 6 months
Urinary continence time	6 months	time to achieve continence

Trial Locations

Locations (1)

Institut Mutualiste montsouris; 🇫🇷 Paris, France