Finished
Trial to Compare Urinary Continence Recovery After Robotic Radical Prostatectomy With or Without Rhabdosphincter Reconstruction.
NCT03302169 · Hospital Universitari Vall d'Hebron Research Institute · Updated 9 Oct 2020
- What is being tested
- Radical prostatectomy with posterior rhabdosphincter reconstruction; Radical prostatectomy without posterior rhabdosphincter reconstruction
- For
- Urinary Incontinence
- Kind of study
- Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
- Who can join
- Ages 18 years to 80 years. About 156 people. The full rules are on the registry page.
- Where
- Spain
- When
- Starts or started 1 Jan 2017, ends 1 Dec 2019. Registered 5 Oct 2017.
- Results
- None posted yet.
In the researchers' words
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.
Sites
- Hospital Universitari Vall d'HebronBarcelona, Spain