Prostate Cancer Clinical Trial

Impact of Robot-assisted Radical Prostatectomy Technique on Short-term Continence Recovery

Summary

To assess and compare the short-term post-operative continence recovery rate in two cohorts of men undergoing Robot Assisted Radical Prostatectomy (RARP), each randomized to undergo RARP with Vattikuti Institute technique or Retzius sparing technique.

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Full Description

Traditionally, RARP is performed using a trans-peritoneal technique that pass anteriorly to the bladder. This technique necessitates the dissection and/or manipulation of many structures, which might compromise post-operative urinary continence recovery. These structures include the pubo-prostatic ligament, Santorini plexus, neurovascular bundle, and veil of Aphrodite. Recently, a "Retzius-sparing" technique to perform RARP has beed described. This approach passes posteriorly to the bladder, through the space of Douglas, which should minimize the damaged to the aforementioned structure. Theoretically, the latter technique should improve post-operative urinary continence recovery. However, a randomized comparison between the "traditional" RARP and "Retzius-sparing" RARP is still lacking.

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Eligibility Criteria

Inclusion Criteria:

All patients with newly diagnosed prostate cancer undergoing robotic-assisted radical prostatectomy at the Vattikuti Urology Institute (performed by single surgeon, MM) as the primary treatment modality
Be able to read and speak English and be able to provide written informed consent

Exclusion Criteria:

patients with high risk prostate cancer,defined as a biopsy Gleason score ≥8 and/or a pre-operative prostate specific antigen value ≥20 ng/ml.
evidence of clinical nodal involvement (cN1) or metastatic disease (M1)
patients participating in a competing study
patients with pre-operative urinary incontinence.

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

120

Study ID:

NCT02352103

Recruitment Status:

Completed

Sponsor:

Henry Ford Health System

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How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

120

Study ID:

NCT02352103

Recruitment Status:

Completed

Sponsor:


Henry Ford Health System

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