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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2019-12-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Urinary Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

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 Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Posterior Rhabdosphincter Reconstruction

Patients in who posterior rhabdosphincter reconstruction is performed

Group Type EXPERIMENTAL

Radical prostatectomy with posterior rhabdosphincter reconstruction

Intervention Type PROCEDURE

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

Standard Technique

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

Group Type ACTIVE_COMPARATOR

Radical prostatectomy without posterior rhabdosphincter reconstruction

Intervention Type PROCEDURE

Standard technique with a running suture to perform the urethrovesical anastomosis

Interventions

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Radical prostatectomy with posterior rhabdosphincter reconstruction

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

Intervention Type PROCEDURE

Radical prostatectomy without posterior rhabdosphincter reconstruction

Standard technique with a running suture to perform the urethrovesical anastomosis

Intervention Type PROCEDURE

Other Intervention Names

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Rocco reconstruction technique Posterior reconstruction Rocco Stitch

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No