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

Primary Purpose

Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Radical prostatectomy with posterior rhabdosphincter reconstruction
Radical prostatectomy without posterior rhabdosphincter reconstruction
Sponsored by
Hospital Universitari Vall d'Hebron Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence focused on measuring Prostate Cancer, Urinary incontinence, Radical prostatectomy, Rhabdosphincter, Robotic Surgery

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Universitari Vall d'Hebron

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Posterior Rhabdosphincter Reconstruction

Standard Technique

Arm Description

Patients in who posterior rhabdosphincter reconstruction is performed

Patients in who posterior rhabdosphincter reconstruction is NOT performed, Standard technique.

Outcomes

Primary Outcome Measures

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
Absence of urinary incontinence (number of PADs/d)
Number of patients using 0-1 PAD/d (EPIC-26 question_5) at 6th month
Absence of urinary incontinence (number of PADs/d)

Secondary Outcome Measures

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

Full Information

First Posted
August 15, 2017
Last Updated
October 7, 2020
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03302169
Brief Title
Trial to Compare Urinary Continence Recovery After Robotic Radical Prostatectomy With or Without Rhabdosphincter Reconstruction.
Acronym
RHABDO-PROST
Official Title
Prospective Randomized Controlled Trial to Compare Early Urinary Continence Recovery After Robotic Assisted Radical Prostatectomy With or Without Posterior Rhabdosphincter Reconstruction.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
November 1, 2019 (Actual)
Study Completion Date
December 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Universitari Vall d'Hebron Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
Keywords
Prostate Cancer, Urinary incontinence, Radical prostatectomy, Rhabdosphincter, Robotic Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
156 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Posterior Rhabdosphincter Reconstruction
Arm Type
Experimental
Arm Description
Patients in who posterior rhabdosphincter reconstruction is performed
Arm Title
Standard Technique
Arm Type
Active Comparator
Arm Description
Patients in who posterior rhabdosphincter reconstruction is NOT performed, Standard technique.
Intervention Type
Procedure
Intervention Name(s)
Radical prostatectomy with posterior rhabdosphincter reconstruction
Other Intervention Name(s)
Rocco reconstruction technique, Posterior reconstruction, Rocco Stitch
Intervention Description
To suture the Denonvilliers fascia and bladder to the median dorsal raphe according to Rocco technique.
Intervention Type
Procedure
Intervention Name(s)
Radical prostatectomy without posterior rhabdosphincter reconstruction
Intervention Description
Standard technique with a running suture to perform the urethrovesical anastomosis
Primary Outcome Measure Information:
Title
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
Description
Absence of urinary incontinence (number of PADs/d)
Time Frame
1 month after surgery
Title
Number of patients using 0-1 PAD/d (EPIC-26 question_5) at 6th month
Description
Absence of urinary incontinence (number of PADs/d)
Time Frame
6 months after surgery
Secondary Outcome Measure Information:
Title
early urinary recovery quantification in Grams (PAD-test 24h)
Description
PAD-test during the first month after surgery
Time Frame
one day before catheter removal, 2 weeks before and 1 month before
Title
Number of patients using 0-1 PAD/d (EPIC-26 question_5) at 12th month
Description
Absence of urinary incontinence (number of PADs/d)
Time Frame
12 months after surgery
Title
Erectile function
Description
SHIM assessment
Time Frame
1, 6 and 12 months
Title
Quality of life I: urinary and bowel function
Description
EPIC-26 urinary and digestive function
Time Frame
1, 6 and 12 months
Title
Quality of life II: urinary function
Description
ICIQ-SF assessment of urinary function
Time Frame
1, 6 and 12 months
Title
Quality of life III: urinary function
Description
IPSS assessment of urinary function
Time Frame
1, 6 and 12 months
Title
Oncological outcome: Biochemical free-recurrence status
Description
serum PSA assessment. Biochemical free-recurrence status = PSA <0.2
Time Frame
1, 6 and 12 months
Title
Anatomopathological parameters: Surgical margins
Description
Surgery margins in prostatectomy specimens
Time Frame
1 month
Title
Anatomopathological parameters: pTNM classification
Description
Pathological pTNM in prostatectomy specimens
Time Frame
1 month

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan Morote, PhD
Organizational Affiliation
Hospital Vall d'Hebron
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35272967
Citation
Salazar A, Regis L, Planas J, Celma A, Trilla E, Morote J. Continence definition and prognostic factors for early urinary continence recovery in posterior rhabdosphincter reconstruction after robot-assisted radical prostatectomy. Post-hoc analysis of a randomised controlled trial. Actas Urol Esp (Engl Ed). 2022 Apr;46(3):159-166. doi: 10.1016/j.acuroe.2021.06.012. Epub 2022 Mar 7. English, Spanish.
Results Reference
derived
PubMed Identifier
33653674
Citation
Salazar A, Regis L, Planas J, Celma A, Santamaria A, Trilla E, Morote J. A Randomised Controlled Trial to Assess the Benefit of Posterior Rhabdosphincter Reconstruction in Early Urinary Continence Recovery after Robot-assisted Radical Prostatectomy. Eur Urol Oncol. 2022 Aug;5(4):460-463. doi: 10.1016/j.euo.2021.02.005. Epub 2021 Feb 27.
Results Reference
derived

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Trial to Compare Urinary Continence Recovery After Robotic Radical Prostatectomy With or Without Rhabdosphincter Reconstruction.

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