Trial to Compare Urinary Continence Recovery After Robotic Radical Prostatectomy With or Without Rhabdosphincter Reconstruction. (RHABDO-PROST)

Vall d'Hebron University Hospital (HUVH)

Status: Completed

Conditions: Urinary Incontinence

Treatments: Procedure: Radical prostatectomy without posterior rhabdosphincter reconstruction; Procedure: Radical prostatectomy with posterior rhabdosphincter reconstruction

Study type: Interventional

Funder types: Other

Identifiers

NCT03302169

PR(AG)330/2016

Details and patient eligibility

About

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.

Enrollment: 156 patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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156 participants in 2 patient groups

Posterior Rhabdosphincter Reconstruction

Experimental group

Description:

Patients in who posterior rhabdosphincter reconstruction is performed

Treatment:

Procedure: Radical prostatectomy with posterior rhabdosphincter reconstruction

Standard Technique

Active Comparator group

Description:

Patients in who posterior rhabdosphincter reconstruction is NOT performed, Standard technique.

Treatment:

Procedure: Radical prostatectomy without posterior rhabdosphincter reconstruction