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

Study Overview
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Brief Summary
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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.

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

Conditions
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Localized Prostate Cancer, Urinary Incontinence

Intervention / Treatment
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* Procedure: Posterior reconstruction


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Posterior reconstruction<br>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<br> <br> |
| No Intervention: No posterior reconstruction<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostatic neoplasms, prostatectomy, robotics, urinary incontinence