Trial to Compare Urinary Continence Recovery After Robotic Radical Prostatectomy With or Without Rhabdosphincter Reconstruction.

Not Applicable

Completed

• Conditions: Urinary Incontinence

• Registration Number: NCT03302169
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Brief Summary

This is a prospective randomized controlled trail to assess early urinary continence recovery rates after robotic assisted radical prostatectomy when a posterior rhabdosphincter reconstruction is performed or not. A hundred forty-six patients with clinically localized and histological confirmed prostate cancer will be enrolled. Continence recovery is defined in the present study as declared urinary continence (absence of incontinence episodes) in the physician interview as no pad use. Continence rates will be explored also by EPIC, ICIQ-SF, IPSS questionnaires 1, 6 and 12 months after the procedure. The sexual function as the secondary objective will be assessed by SHIM questionnaire.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2017-08-15
• Study First Submitted QC: 2017-09-30
• Study First Posted: 2017-10-05
• Primary Completion: 2019-11-01
• Study Completion: 2019-12-01
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-07
• Last Update Posted: 2020-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 156

Inclusion Criteria

• Histological confirmation of prostate cancer
• Localized or locally advanced prostate cancer
• Informed consent signed

Exclusion Criteria

• Presence of urinary incontinence prior to the procedure
• Previous radiation therapy of the prostate or pelvis
• Presence of any prostatic surgery prior to the procedure
• Prior medical history of psychiatric diseases or drug addiction
• Any condition that contraindicates a radical prostatectomy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of patients using 0-1 PAD/d (EPIC-26 question_5) at 6th month	6 months after surgery	Absence of urinary incontinence (number of PADs/d)
Number of patients using 0-1 PAD/d (EPIC-26 question_5) at 1st monthNumber of patients using 0-1 PAD/d (EPIC-26 question_5) at 1st month	1 month after surgery	Absence of urinary incontinence (number of PADs/d)

Secondary Outcome Measures

Name	Time	Method
Quality of life II: urinary function	1, 6 and 12 months	ICIQ-SF assessment of urinary function
early urinary recovery quantification in Grams (PAD-test 24h)	one day before catheter removal, 2 weeks before and 1 month before	PAD-test during the first month after surgery
Erectile function	1, 6 and 12 months	SHIM assessment
Number of patients using 0-1 PAD/d (EPIC-26 question_5) at 12th month	12 months after surgery	Absence of urinary incontinence (number of PADs/d)
Quality of life I: urinary and bowel function	1, 6 and 12 months	EPIC-26 urinary and digestive function
Anatomopathological parameters: pTNM classification	1 month	Pathological pTNM in prostatectomy specimens
Quality of life III: urinary function	1, 6 and 12 months	IPSS assessment of urinary function
Oncological outcome: Biochemical free-recurrence status	1, 6 and 12 months	serum PSA assessment. Biochemical free-recurrence status = PSA \<0.2
Anatomopathological parameters: Surgical margins	1 month	Surgery margins in prostatectomy specimens

Trial Locations

Locations (1)

Hospital Universitari Vall d'Hebron; 🇪🇸 Barcelona, Spain