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

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ClinicalTrials.gov Identifier: NCT03302169
Recruitment Status : Recruiting
First Posted : October 5, 2017
Last Update Posted : November 21, 2017
Sponsor:
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Urinary Incontinence Procedure: Radical prostatectomy with posterior rhabdosphincter reconstruction Procedure: Radical prostatectomy without posterior rhabdosphincter reconstruction Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 146 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: This is a prospective randomized controlled trial to assess early urinary continence recovery rates after robotic assisted radical prostatectomy when a posterior rhabdosphincter reconstruction is performed or not.
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Prospective Randomized Controlled Trial to Compare Early Urinary Continence Recovery After Robotic Assisted Radical Prostatectomy With or Without Posterior Rhabdosphincter Reconstruction.
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Number of patients using 0-1 PAD/d (EPIC-26 question_3) at 1st monthNumber of patients using 0-1 PAD/d (EPIC-26 question_3) at 1st month [ Time Frame: 1 month after surgery ]
    Absence of urinary incontinence (number of PADs/d)

  2. Number of patients using 0-1 PAD/d (EPIC-26 question_3) at 6th month [ Time Frame: 6 months after surgery ]
    Absence of urinary incontinence (number of PADs/d)


Secondary Outcome Measures :
  1. 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

  2. Number of patients using 0-1 PAD/d (EPIC-26 question_3) at 12th month [ Time Frame: 12 months after surgery ]
    Absence of urinary incontinence (number of PADs/d)

  3. Erectile function [ Time Frame: 1, 6 and 12 months ]
    SHIM assessment

  4. Quality of life I: urinary and bowel function [ Time Frame: 1, 6 and 12 months ]
    EPIC-26 urinary and digestive function

  5. Quality of life II: urinary function [ Time Frame: 1, 6 and 12 months ]
    ICIQ-SF assessment of urinary function

  6. Quality of life III: urinary function [ Time Frame: 1, 6 and 12 months ]
    IPSS assessment of urinary function

  7. Oncological outcome: Biochemical free-recurrence status [ Time Frame: 1, 6 and 12 months ]
    serum PSA assessment. Biochemical free-recurrence status = PSA <0.2

  8. Anatomopathological parameters: Surgical margins [ Time Frame: 1 month ]
    Surgery margins in prostatectomy specimens

  9. Anatomopathological parameters: pTNM classification [ Time Frame: 1 month ]
    Pathological pTNM in prostatectomy specimens



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03302169


Contacts
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Contact: Lucas Regis, PhD +34 934 89 30 00 ext 6370 lregis@vhebron.net
Contact: Juan Morote, PhD +34 934 89 30 00 ext 6370 jmorote@vhebron.net

Locations
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Spain
Hospital Universitari Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Contact: Lucas Regis, PhD    +34 934 89 30 00 ext 6370    lregis@vhebron.net   
Principal Investigator: Juan Morote, PhD         
Principal Investigator: Jacques Planas, PhD         
Sub-Investigator: Lucas Regis, PhD         
Sub-Investigator: Ana Celma, PhD         
Sub-Investigator: Aina Salazar, MD         
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
Investigators
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Principal Investigator: Juan Morote, PhD Hospital Vall d'Hebron

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Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT03302169     History of Changes
Other Study ID Numbers: PR(AG)330/2016
First Posted: October 5, 2017    Key Record Dates
Last Update Posted: November 21, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:
Prostate Cancer
Urinary incontinence
Radical prostatectomy
Rhabdosphincter
Robotic Surgery

Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders