Localized Prostate Cancer, Urinary Incontinence
Conditions
Keywords
prostatic neoplasms, prostatectomy, robotics, urinary incontinence
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.
Interventions
PROCEDUREPosterior reconstruction
Sponsors
Seoul National University Bundang Hospital
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete recovery of urinary continence | 6 months | Duration of complete continence recovery defined as no pad use measured by question 5 of EPIC questionnaire. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complication | 6 months | Complication by modified Clavien-Dindo grade |
| Duration of social continence recovery | 6 months | Defined as 0 or 1 measured by EPIC question 5. |
| Continence score at 3 months | 3 months | By EPIC question 5. * 0 vs. 1-3 * mean value |
| Estimated blood loss | At the day of surgery | — |
| Self perception (QoL) of urinary function at 3 months | 3 months | By EPIC question 7, * 0-1 vs. 2-4 * mean value |
| Total operative time | At the day of surgery | * Total operative time * Console time |
| Urinary leak at 3 months | 3 months | By EPIC question 1, * 1-3 vs. 4-5 * mean value |
Countries
South Korea
Outcome results
None listed