NCT03302169

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 156 (actual)
• Sponsor: Hospital Universitari Vall d'Hebron Research Institute · Academic / Other
• Sex: Male
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	Radical prostatectomy with posterior rhabdosphincter reconstruction	To suture the Denonvilliers fascia and bladder to the median dorsal raphe according to Rocco technique.
PROCEDURE	Radical prostatectomy without posterior rhabdosphincter reconstruction	Standard technique with a running suture to perform the urethrovesical anastomosis

Timeline

• Start date: 2017-01-01
• Primary completion: 2019-11-01
• Completion: 2019-12-01
• First posted: 2017-10-05
• Last updated: 2020-10-09

Locations

1 site across 1 country: Spain