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

Does the Posterior Reconstruction of the Rhabdosphincter Improve Early Recovery of Continence After Robotic-Assisted Radical Prostatectomy? A Multicenter Randomized Controlled Trial. A Phase III Open-label Prospective International Multicenter Randomized Controlled Study for the Evaluation of the Efficacy of PRR, in Patients Subjected to RALP, Measured in Terms of Early Recovery of the Continence.

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01809522

Acronym

PRR

Enrollment

1500

Registered

2013-03-12

Start date

2013-01-31

Completion date

Unknown

Last updated

2013-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Incontinence

Keywords

Robotic-assisted radical prostatectomy, Urinary continence, Posterior reconstruction of the rhabdosphincter, Posterior musculofascial plate reconstruction

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.

Interventions

PROCEDUREPosterior reconstruction of the rhabdosphincter

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 80 Years

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;

Design outcomes

Primary

Measure	Time frame	Description
Urinary continence	12 months	No urinary leakages, assessed with the EPIC Questionnaire.

Secondary

Measure	Time frame	Description
Oncologic radicality	12 months	PSA \< 0,2 ng/ml.
Sexual potency	12 months	Potency sufficient for intercourse, with or without use of PDE5i, assessed with the IIEF Questionnaire.

Countries

Italy

Contacts

Primary ContactBernardo Rocco, MD

bernardo.rocco@gmail.com+390255034549

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026