Clinical trial NCT03302169: Trial to Compare Urinary Continence Recovery After Robotic Radical Prostatectomy With or Without Rhabdosphincter Reconstruction.
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
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Keywords: Prostate Cancer
Urinary incontinence
Radical prostatectomy
Rhabdosphincter
Robotic Surgery
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2017-10-05
Enrollment: 156
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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
timeFrame: 1 month after surgery
measure: Number of patients using 0-1 PAD/d (EPIC-26 question_5) at 6th month
timeFrame: 6 months after surgery
Secondary outcomes:
measure: early urinary recovery quantification in Grams (PAD-test 24h)
timeFrame: one day before catheter removal, 2 weeks before and 1 month before
measure: Number of patients using 0-1 PAD/d (EPIC-26 question_5) at 12th month
timeFrame: 12 months after surgery
measure: Erectile function
timeFrame: 1, 6 and 12 months
measure: Quality of life I: urinary and bowel function
timeFrame: 1, 6 and 12 months
measure: Quality of life II: urinary function
timeFrame: 1, 6 and 12 months
measure: Quality of life III: urinary function
timeFrame: 1, 6 and 12 months
measure: Oncological outcome: Biochemical free-recurrence status
timeFrame: 1, 6 and 12 months
measure: Anatomopathological parameters: Surgical margins
timeFrame: 1 month
measure: Anatomopathological parameters: pTNM classification
timeFrame: 1 month
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
Study officials:
affiliation: Hospital Vall d'Hebron
name: Juan Morote, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.