Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
NCT Number: NCT01714219
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.
Looking for future studies?
Notify MeMale
Interventional
Not applicable
Seongnam-si, Gyeonggi-do, South Korea
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 6 months
Duration of complete continence recovery defined as no pad use measured by question 5 of EPIC questionnaire.
Time frame: 6 months
Defined as 0 or 1 measured by EPIC question 5.
Time frame: 3 months
By EPIC question 5.
Time frame: 3 months
By EPIC question 1,
Time frame: 3 months
By EPIC question 7,
Time frame: At the day of surgery
Time frame: At the day of surgery
Time frame: 6 months
Complication by modified Clavien-Dindo grade
Seoul National University Hospital
Other
Effect of New Posterior Reconstruction Method on Recovery of Continence After Robot-assisted Laparoscopic Prostatectomy: Prospective, Single-blinded, Randomized Controlled Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT01902680
Genital Diseases, Genital Diseases, Male
Toulouse, France
View Trial DetailsNCT02435472
Active Surveillance for Prostate Cancer, Behavior
San Francisco, California, United States
View Trial DetailsNCT01931046
Genital Diseases, Genital Diseases, Male
San Diego, California, United States
View Trial DetailsNCT02297386
Genital Diseases, Genital Diseases, Male
New York, United States
View Trial Details