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

October 7, 2020 updated by: Hospital Universitari Vall d'Hebron Research Institute

Prospective Randomized Controlled Trial to Compare Early Urinary Continence Recovery After Robotic Assisted Radical Prostatectomy With or Without Posterior Rhabdosphincter Reconstruction.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

156

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Posterior Rhabdosphincter Reconstruction
Patients in who posterior rhabdosphincter reconstruction is performed
Procedure: Radical prostatectomy with posterior rhabdosphincter reconstruction
To suture the Denonvilliers fascia and bladder to the median dorsal raphe according to Rocco technique.
Other Names:
  • Rocco reconstruction technique
  • Posterior reconstruction
  • Rocco Stitch
ACTIVE_COMPARATOR: Standard Technique
Patients in who posterior rhabdosphincter reconstruction is NOT performed, Standard technique.
Procedure: Radical prostatectomy without posterior rhabdosphincter reconstruction
Standard technique with a running suture to perform the urethrovesical anastomosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 1 month after surgery
Absence of urinary incontinence (number of PADs/d)
1 month after surgery
Number of patients using 0-1 PAD/d (EPIC-26 question_5) at 6th month
Time Frame: 6 months after surgery
Absence of urinary incontinence (number of PADs/d)
6 months after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Investigators

  • Principal Investigator: Juan Morote, PhD, Hospital Vall d'Hebron

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2017

Primary Completion (ACTUAL)

November 1, 2019

Study Completion (ACTUAL)

December 1, 2019

Study Registration Dates

First Submitted

August 15, 2017

First Submitted That Met QC Criteria

September 30, 2017

First Posted (ACTUAL)

October 5, 2017

Study Record Updates

Last Update Posted (ACTUAL)

October 9, 2020

Last Update Submitted That Met QC Criteria

October 7, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR(AG)330/2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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