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

NCT01714219 | Completed DMC

• 1 other identifier: SNUBH-URO-2012-02
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Localized Prostate Cancer; Urinary Incontinence

Keywords

prostatic neoplasms; prostatectomy; robotics; urinary incontinence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Duration of social continence recovery

  6 months

• Continence score at 3 months

  3 months

• Urinary leak at 3 months

  3 months

• Self perception (QoL) of urinary function at 3 months

  3 months

• Total operative time

  At the day of surgery

Study Arms (2)

Posterior reconstruction

EXPERIMENTAL

* 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 posterior reconstruction

NO INTERVENTION

* 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

Interventions

Posterior reconstruction PROCEDURE

Posterior reconstruction

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Seoul National University Bundang Hospital: collaborator

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, Gyeonggi-do, South Korea

Location

MeSH Terms

Conditions

Urinary Incontinence; Prostatic Neoplasms

Interventions

Posterior Cruciate Ligament Reconstruction

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Prostatic Diseases

Intervention Hierarchy (Ancestors)

Orthopedic Procedures; Therapeutics; Arthroplasty; Surgical Procedures, Operative; Plastic Surgery Procedures

Study Officials

• Sang Eun Lee, M.D., Ph.D.

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 19, 2012
• First Posted: October 25, 2012
• Study Start: October 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: September 29, 2014

Record last verified: 2014-09

Locations

KR (1)