Effect of New Posterior Reconstruction Method on Recovery of Continence After Robot-assisted Laparoscopic Prostatectomy

Effect of New Posterior Reconstruction Method on Recovery of Continence After Robot-assisted Laparoscopic Prostatectomy: Prospective, Single-blinded, Randomized Controlled Trial

Incontinence is one of the most common complications of radical prostatectomy. The continence rate is not significantly improved even by robot-assisted laparoscopic prostatectomy (RALP). However, some reports suggested that posterior reconstruction (PR) behind vesicourethral anastomosis could improve early recovery of continence during open, laparoscopic or robot-assisted radical prostatectomy.

But, recent prospective studies reported no benefit of PR after RALP, which was the opposite result of those of previous studies. However the PR techniques used in these prospective studies seem to be quite different from the previous techniques. They seem to have used single-step PR, which opposes the median dorsal fibrous raphe (MDFR) only to the Denonvilliers' fascia (DF). By contrast, the original technique incorporated additional reconstruction between the MDFR and the posterior bladder wall 1-2 cm from the new bladder neck.

Our group identified this anatomic structure as the posterior counterpart of the detrusor apron (PDA). The PDA is a strong, thick functional tissue containing muscle that is more appropriate for pulling and fixing the MDFR than the DF. As such, we hypothesized that the key proximal structure for PR is not DF, but rather PDA. Furthermore, single-step reconstruction between MDFR and PDA could be enough for PR. We previously investigated whether our new PR technique, which entails opposition of the MDFR solely to the PDA, would improve continence recovery compared with the standard RALP technique without PR. And our retrospective study demonstrated that this new PR technique during RALP significantly shortens the time to the recovery of continence compared with the standard technique, which does not incorporate PR (Int J Urol, 2012;19:683-7).

Thus, we plan to validate this result by a well-designed, prospective, randomized controlled study.

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence; Localized Prostate Cancer
• Intervention / Treatment: Procedure: Posterior reconstruction

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam, Gyeonggi-do, Korea, Republic of, Gyeonggi-do
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• pathologically proven localized prostate cancer (≤cT3a)
• patients to undergo robot-assisted laparoscopic prostatectomy by a single surgeon (Sang Eun Lee)

Exclusion Criteria:

• prior hormone therapy
• prior radiation treatment on prostate or pelvis
• preoperative urinary incontinence
• refused to participate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Posterior reconstruction; New posterior reconstruction, which entails opposition of the median dorsal fibrous raphe solely to the posterior counterpart of the detrusor apron; Vesicourethral anastomosis using the van Velthoven method; Anterior reconstruction, which involved opposing the anterior detrusor apron to the remaining puboprostatic ligaments and dorsal vascular complex	Procedure: Posterior reconstruction
NO_INTERVENTION: No posterior reconstruction; No posterior reconstruction; Vesicourethral anastomosis using the van Velthoven method; Anterior reconstruction, which involved opposing the anterior detrusor apron to the remaining puboprostatic ligaments and dorsal vascular complex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete recovery of urinary continence	Duration of complete continence recovery defined as no pad use measured by question 5 of EPIC questionnaire.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of social continence recovery	Defined as 0 or 1 measured by EPIC question 5.	6 months
Continence score at 3 months	By EPIC question 5.; 0 vs. 1-3; mean value	3 months
Urinary leak at 3 months	By EPIC question 1,; 1-3 vs. 4-5; mean value	3 months
Self perception (QoL) of urinary function at 3 months	By EPIC question 7,; 0-1 vs. 2-4; mean value	3 months
Total operative time	Total operative time; Console time	At the day of surgery
Estimated blood loss		At the day of surgery
Complication	Complication by modified Clavien-Dindo grade	6 months

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Seoul National University Bundang Hospital
• Investigators: Principal Investigator: Sang Eun Lee, M.D., Ph.D., Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (ACTUAL): March 1, 2014
• Study Completion (ACTUAL): March 1, 2014

Study Registration Dates

• First Submitted: October 19, 2012
• First Submitted That Met QC Criteria: October 22, 2012
• First Posted (ESTIMATE): October 25, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): September 29, 2014
• Last Update Submitted That Met QC Criteria: September 25, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: urinary incontinence; robotics; prostatectomy; prostatic neoplasms
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis
• Other Study ID Numbers: SNUBH-URO-2012-02