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

NCT03302169 | Completed

• 1 other identifier: PR(AG)330/2016
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence

Keywords

Prostate Cancer; Urinary incontinence; Radical prostatectomy; Rhabdosphincter; Robotic Surgery

Outcome Measures

Primary Outcomes (2)

• 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)

  1 month after surgery

• Number of patients using 0-1 PAD/d (EPIC-26 question_5) at 6th month

  Absence of urinary incontinence (number of PADs/d)

  6 months after surgery

Secondary Outcomes (9)

• early urinary recovery quantification in Grams (PAD-test 24h)

  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

  12 months after surgery

• Erectile function

  1, 6 and 12 months

• Quality of life I: urinary and bowel function

  1, 6 and 12 months

• Quality of life II: urinary function

  1, 6 and 12 months

Study Arms (2)

Posterior Rhabdosphincter Reconstruction

EXPERIMENTAL

Patients in who posterior rhabdosphincter reconstruction is performed

Procedure: Radical prostatectomy with posterior rhabdosphincter reconstruction

Standard Technique

ACTIVE COMPARATOR

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

Procedure: Radical prostatectomy without posterior rhabdosphincter reconstruction

Interventions

Radical prostatectomy with posterior rhabdosphincter reconstruction PROCEDURE

To suture the Denonvilliers fascia and bladder to the median dorsal raphe according to Rocco technique.

Also known as: Rocco reconstruction technique, Posterior reconstruction, Rocco Stitch

Posterior Rhabdosphincter Reconstruction

Radical prostatectomy without posterior rhabdosphincter reconstruction PROCEDURE

Standard technique with a running suture to perform the urethrovesical anastomosis

Standard Technique

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological confirmation of prostate cancer
• Localized or locally advanced prostate cancer
• Informed consent signed

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (1)

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Related Publications (2)

• 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.

  PMID: 35272967 DERIVED

• 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.

  PMID: 33653674 DERIVED

MeSH Terms

Conditions

Urinary Incontinence; Prostatic Neoplasms

Interventions

Posterior Cruciate Ligament Reconstruction

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Prostatic Diseases

Intervention Hierarchy (Ancestors)

Orthopedic Procedures; Therapeutics; Arthroplasty; Surgical Procedures, Operative; Plastic Surgery Procedures

Study Officials

• Juan Morote, PhD

  Hospital Vall d'Hebron

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 15, 2017
• First Posted: October 5, 2017
• Study Start: January 1, 2017
• Primary Completion: November 1, 2019
• Study Completion: December 1, 2019
• Last Updated: October 9, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)