Prospective RCT on Post Prostatectomy Urine Leak

Institut Mutualiste Montsouris

Status and phase: Unknown; Phase 3

Conditions: Prostate Cancer; Urinary Incontinence

Treatments: Drug: Duloxetine; Behavioral: Pelvic Floor Muscle Training

Study type: Interventional

Funder types: Other

Identifiers

NCT02367404

URO-01-2014

Details and patient eligibility

About

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).

Enrollment: 240 estimated patients

Sex: Male

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 4 patient groups

Control

No Intervention group

Description:

Keigel's exercise

Duloxetine

Active Comparator group

Description:

Duloxetine 60mg for 3 months

Treatment:

Drug: Duloxetine

Duloxetine + PMFT

Active Comparator group

Description:

Duloxetine 60mg for 3 months PMFT weekly for 3 months

Treatment:

Behavioral: Pelvic Floor Muscle Training

Drug: Duloxetine

Pelvic Floor Muscle Training

Active Comparator group

Description:

PMFT weekly for 3 months

Treatment:

Behavioral: Pelvic Floor Muscle Training