NCT01809522

Brief Summary

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 12, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Last Updated

March 13, 2013

Status Verified

March 1, 2013

Enrollment Period

2.2 years

First QC Date

March 9, 2013

Last Update Submit

March 12, 2013

Conditions

Urinary Incontinence

Keywords

Robotic-assisted radical prostatectomyUrinary continencePosterior reconstruction of the rhabdosphincterPosterior musculofascial plate reconstruction

Outcome Measures

Primary Outcomes (1)

  • Urinary continence

    No urinary leakages, assessed with the EPIC Questionnaire.

    12 months

Secondary Outcomes (2)

  • Oncologic radicality

    12 months

  • Sexual potency

    12 months

Study Arms (2)

Posterior reconstruction of the musculofascial plate

EXPERIMENTAL

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.

Procedure: Posterior reconstruction of the rhabdosphincter

Standard radical prostectomy

NO INTERVENTION

Interventions

Posterior reconstruction of the rhabdosphincterPROCEDURE
Posterior reconstruction of the musculofascial plate

Eligibility Criteria

Age18 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico

Milan, 20014, Italy

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Bernardo Rocco, MD

CONTACT

+390255034549bernardo.rocco@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 9, 2013

First Posted

March 12, 2013

Study Start

January 1, 2013

Primary Completion

March 1, 2015

Last Updated

March 13, 2013

Record last verified: 2013-03

Locations

IT(1)