Prospective RCT on Post Prostatectomy Urine Leak

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02367404
• Other study ID #: URO-01-2014
• Status: Recruiting
• Phase: Phase 3
• First received: February 13, 2015
• Last updated: September 12, 2016
• Start date: May 2015
• Est. completion date: June 2017

Study information

• Verified date: September 2016
• Source: Institut Mutualiste Montsouris
• Contact: Rafael Sanchez-Salas, MD
• Phone: 0156616617
• Email: rafael.sanchez-salas[@]imm.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical 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.

• 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: June 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Enuresis
• Prostate Cancer
• Urinary Incontinence

Intervention

Drug:
• Duloxetine
Duloxetine 60mg OD for 3 months

Behavioral:
• Pelvic Floor Muscle Training
PMFT weekly for 3 months

Locations

Country	Name	City	State
France	Institut Mutualiste montsouris	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Institut Mutualiste Montsouris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary continence proportion	Proportion of patient achieving continence at 6 months	6 months	No
Secondary	Urinary continence time	time to achieve continence	6 months	No
Secondary	Urinary quality of life	Quality of life tested in relation to incontinence using questionnaire at 6 months	6 months	No