Does Posterior Reconstruction of the Rhabdosphincter Improve Early Recovery of Continence After Robotic-Assisted Radical Prostatectomy? (PRR)

Institute of Hospitalization and Scientific Care (IRCCS)

Status and phase: Unknown; Phase 3

Conditions: Urinary Incontinence

Treatments: Procedure: Posterior reconstruction of the rhabdosphincter

Study type: Interventional

Funder types: Other

Identifiers

NCT01809522

Posterior Reconstruction

Details and patient eligibility

About

The present study is a multicenter randomized, controlled trial, whose aim is to verify the effect of the posterior reconstruction of the rhabdosphincter after robot-assisted radical prostatectomy on early recovery of urinary continence.

Enrollment: 1,500 estimated patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥18 and ≤ 80 years;
• Biopsy proven clinically localized prostate cancer;
• Informed consent obtained and signed;
• Understanding of, and willingness to comply with, the study procedures.

Exclusion criteria

• Pre-operative incontinence;
• Salvage prostatectomy (defined as a prostatectomy prescribed after the failure of a different primary treatment);
• Surgical posterior plane at the peri - rectal fat, without preserving an edge of the Denonvilliers;
• History of psychiatric or addictive disorder or other medical condition that, in the opinion of the investigator, would preclude the patient from meeting the trial requirements;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,500 participants in 2 patient groups

Posterior reconstruction of the musculofascial plate

Experimental group

Description:

These patients will receive reconstruction of the muscolofascial plate after radical prostatectomy. The reconstruction will be performed using two 3-0 Poliglecaprone sutures (on RB-1 needles) tied together, with each individual length being 12-15 cm. seven - Ten knots will be placed when tying the sutures to provide a bolster. The free edge of the remaining Denonvillier's fascia will be identified after the prostatectomy and approximated to the posterior aspect of the rhabdosphincter and the posterior median raphe using one arm of the continuous suture. As a rule, four passes will be taken from the right to the left and the suture is locked. The second layer of the reconstruction will be then performed with the other arm of the suture approximating the posterior lip of the bladder neck (full thickness) and the vesicoprostatic muscle to the posterior urethral edge and to the already reconstructed median raphe .This suture will be then tied to the end of the first suture arm.

Treatment:

Procedure: Posterior reconstruction of the rhabdosphincter

Standard radical prostectomy

No Intervention group