NCT02352103

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2015

Typical duration for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 2, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

September 18, 2019

Completed
Last Updated

February 25, 2022

Status Verified

February 1, 2022

Enrollment Period

1.2 years

First QC Date

January 22, 2015

Results QC Date

February 22, 2019

Last Update Submit

February 11, 2022

Conditions

Urinary Incontinence

Keywords

prostate cancerUrinary continencerobotic assisted radical prostatectomyVattikuti Urology Institute (VIP) radical prostatectomyRetzius sparing radical prostatectomy

Outcome Measures

Primary Outcomes (1)

  • Urinary Continence Recovery

    24-hour pad weights

    One week after the removal of the suprapubic urinary catheter

Secondary Outcomes (5)

  • Number of Participants With Urinary Continence Recovery

    within 3 months from the intervention

  • Number of Participants With Peri and Postoperative Complications

    1-year median follow up

  • Number of Participants Who Regained Potency Postoperatively (as Measured by Sexual Health Inventory for Men (SHIM) Score of 17 or Greater)

    1-year median follow up

  • Number of Participants Who Had Biochemical Recurrence (Post-operative Prostate-Specific Antigen (PSA) Value >=0.2 ng/ml)

    1-year median follow up

  • Post-operative Urinary Function and Urinary Function-related Quality of Life

    Within 3 months from the intervention

Other Outcomes (2)

  • Number of Patients Who Regained Urinary Continence Postoperatively

    1 year median follow up

  • Post-operative Urinary Function and Urinary Function-related Quality of Life

    1 year median follow up

Study Arms (2)

Control arm

ACTIVE COMPARATOR

Vattikuti Urology Institute radical prostatectomy da Vinci Surgical System

Procedure: Vattikuti Urology Institute radical prostatectomyDevice: da Vinci Surgical System

Treatment arm

EXPERIMENTAL

Retzius sparing radical prostatectomy da Vinci Surgical System

Procedure: Retzius sparing radical prostatectomyDevice: da Vinci Surgical System

Interventions

Retzius sparing radical prostatectomyPROCEDURE

Robotic assisted laparoscopic radical prostatectomy based on Retzius sparing technique

Treatment arm
Vattikuti Urology Institute radical prostatectomyPROCEDURE

Robotic assisted laparoscopic radical prostatectomy based on Vattikuti Urology Institute technique

Control arm
da Vinci Surgical SystemDEVICE

The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery.

Control armTreatment arm

Eligibility Criteria

Age40 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Henry Ford West Bloomfield Hospital

West Bloomfield, Michigan, 48322, United States

Location

Related Publications (2)

  • Dalela D, Jeong W, Prasad MA, Sood A, Abdollah F, Diaz M, Karabon P, Sammon J, Jamil M, Baize B, Simone A, Menon M. A Pragmatic Randomized Controlled Trial Examining the Impact of the Retzius-sparing Approach on Early Urinary Continence Recovery After Robot-assisted Radical Prostatectomy. Eur Urol. 2017 Nov;72(5):677-685. doi: 10.1016/j.eururo.2017.04.029. Epub 2017 May 6.

    PMID: 28483330RESULT

  • Menon M, Dalela D, Jamil M, Diaz M, Tallman C, Abdollah F, Sood A, Lehtola L, Miller D, Jeong W. Functional Recovery, Oncologic Outcomes and Postoperative Complications after Robot-Assisted Radical Prostatectomy: An Evidence-Based Analysis Comparing the Retzius Sparing and Standard Approaches. J Urol. 2018 May;199(5):1210-1217. doi: 10.1016/j.juro.2017.11.115. Epub 2017 Dec 7.

    PMID: 29225060RESULT

Related Links

MeSH Terms

Conditions

Urinary IncontinenceProstatic Neoplasms

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsGenital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesProstatic Diseases

Results Point of Contact

Title
Deepansh Dalela, MD
Organization
Vattikuti Urology Institute, Henry Ford Hospital
ddalela1@hfhs.org
3139162600

Study Officials

  • Mani Menon, MD

    Henry Ford Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Vattikuti Urology Institute

Study Record Dates

First Submitted

January 22, 2015

First Posted

February 2, 2015

Study Start

January 1, 2015

Primary Completion

April 1, 2016

Study Completion

May 1, 2018

Last Updated

February 25, 2022

Results First Posted

September 18, 2019

Record last verified: 2022-02

Locations

US(2)