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Application of Dried Human Amnion Graft to Improve Post-Prostatectomy Incontinence and Potency: A Randomized Exploration Study Protocol

Dimitri Barski, Holger Gerullis, Thorsten Ecke, Mihaly Boros, Jan Brune, Ulrich Beutner, Igor Tsaur, Albert Ramon & Thomas Otto

abstract

INTRODUCTION
Incontinence (up to 20%) and erectile dysfunction (up to 70%) occur frequently after radical prostatectomy (RP) in patients with localized prostate cancer. Human amniotic membrane (HAM) can improve tissue regeneration and functional outcome after RP owing to the growth factors and unique immune tolerance. Preliminary studies showed the potential value of HAM in the reconstruction of the urinary tract and nerve protection during RP.

METHODS
A protocol is developed for a prospective, randomized, single-blind, single-surgeon, placebo-controlled exploration study of the efficacy and safety of dehydrated human amnion membrane placed around the neurovascular bundle (NVB) and vesicourethral anastomosis (VUA) during RP for the treatment of localized prostate cancer. Eligible for inclusion are patients with localized prostate cancer, requiring a surgical procedure and exclusion of preoperative incontinence and erectile dysfunction. The patients are randomized 1:1 to HAM vs. placebo and blinded during the study period. According to the T test with an alpha of 0.05 and a power of 80% and expecting a dropout of 20% of the patients, an adjusted sample size per arm of 164 patients is required.

PLANNED OUTCOMES
The primary outcome is a postoperative continence measured as 24-h pad test up to 12 months postoperatively. Secondary outcomes are potency, time of postoperative catheter removal, postoperative complications, and biochemical recurrence. The protocol for this randomized exploration study defines the conditions to assess the efficacy and safety of HAM application during RP in order to improve the postoperative functional outcome. This trial should pave the way for future studies of tissue engineering in an effort to reduce the morbidity of RP.

TRIAL REGISTRATION
Clinicaltrials.gov, identifier NCT03864939.
   
citation Barski D, Gerullis H, Ecke T, Boros M, Brune J, Beutner U, Tsaur I, Ramon A, Otto T. Application of Dried Human Amnion Graft to Improve Post-Prostatectomy Incontinence and Potency: A Randomized Exploration Study Protocol. Adv Ther 2019; 37:592-602.
   
type journal paper/review (English)
date of publishing 28-11-2019
journal title Adv Ther (37/1)
ISSN electronic 1865-8652
pages 592-602
PubMed 31782131
DOI 10.1007/s12325-019-01158-3