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

Urinary Incontinence Clinical Trial

Official title:

The Impact of Retzius-sparing Approach for Robot-assisted Laparoscopic Radical Prostatectomy on Short-term Continence Recovery: Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02352103
• Other study ID #: 9220
• Status: Completed
• Phase: Phase 3
• Start date: January 2015
• Est. completion date: May 2018

Study information

• Verified date: February 2022
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 2018
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Urinary Incontinence

Intervention

Procedure:
• Retzius sparing radical prostatectomy
Robotic assisted laparoscopic radical prostatectomy based on Retzius sparing technique
• Vattikuti Urology Institute radical prostatectomy
Robotic assisted laparoscopic radical prostatectomy based on Vattikuti Urology Institute technique

Device:
• da Vinci Surgical System
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.

Locations

Country	Name	City	State
United States	Henry Ford Hospital	Detroit	Michigan
United States	Henry Ford West Bloomfield Hospital	West Bloomfield	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

References & 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 Rob — View Citation

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 R — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Patients Who Regained Urinary Continence Postoperatively	0 pad per day	1 year median follow up
Other	Post-operative Urinary Function and Urinary Function-related Quality of Life	MSKCC (Memorial Sloan Kettering Cancer Center) STAR questionnaire (symptom tracking and reporting). Score ranges from 0-25, with higher scores indicating better urinary function	1 year median follow up
Primary	Urinary Continence Recovery	24-hour pad weights	One week after the removal of the suprapubic urinary catheter
Secondary	Number of Participants With Urinary Continence Recovery	0 pad per day	within 3 months from the intervention
Secondary	Number of Participants With Peri and Postoperative Complications	Clavien-Dindo complications	1-year median follow up
Secondary	Number of Participants Who Regained Potency Postoperatively (as Measured by Sexual Health Inventory for Men (SHIM) Score of 17 or Greater)	SHIM ranges from 0-25 with higher scores indicating better sexual function; a score of >=22 is normal and >=17 is considered mild ED	1-year median follow up
Secondary	Number of Participants Who Had Biochemical Recurrence (Post-operative Prostate-Specific Antigen (PSA) Value >=0.2 ng/ml)	Patients without biochemical evidence of disease recurrence (i.e. postop PSA >=0.2 ng/mL)	1-year median follow up
Secondary	Post-operative Urinary Function and Urinary Function-related Quality of Life	International Prostatic Symptom Score (continuous score from 0-35, higher scores indicating worse urinary function)	Within 3 months from the intervention

External Links

•   A Pragmatic Randomized Controlled Trial Examining the Impact of the Retzius-sparing Approach on Early Urinary Continence Recovery After Robot-assisted Radical Prostatectomy
•   Functional Recovery, Oncologic Outcomes and Postoperative Complications after Robot-Assisted Radical Prostatectomy: An Evidence-Based Analysis Comparing the Retzius Sparing and Standard Approaches