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

Urinary Incontinence Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03302169
• Other study ID #: PR(AG)330/2016
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: December 1, 2019

Study information

• Verified date: October 2020
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: December 1, 2019
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Universitari Vall d'Hebron	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	early urinary recovery quantification in Grams (PAD-test 24h)	PAD-test during the first month after surgery	one day before catheter removal, 2 weeks before and 1 month before
Secondary	Number of patients using 0-1 PAD/d (EPIC-26 question_5) at 12th month	Absence of urinary incontinence (number of PADs/d)	12 months after surgery
Secondary	Erectile function	SHIM assessment	1, 6 and 12 months
Secondary	Quality of life I: urinary and bowel function	EPIC-26 urinary and digestive function	1, 6 and 12 months
Secondary	Quality of life II: urinary function	ICIQ-SF assessment of urinary function	1, 6 and 12 months
Secondary	Quality of life III: urinary function	IPSS assessment of urinary function	1, 6 and 12 months
Secondary	Oncological outcome: Biochemical free-recurrence status	serum PSA assessment. Biochemical free-recurrence status = PSA <0.2	1, 6 and 12 months
Secondary	Anatomopathological parameters: Surgical margins	Surgery margins in prostatectomy specimens	1 month
Secondary	Anatomopathological parameters: pTNM classification	Pathological pTNM in prostatectomy specimens	1 month