Status:
UNKNOWN
Application of Dried Human Amnion Graft to Improve Postprostatectomy Incontinence and Potency
Lead Sponsor:
German Centre for Assessment and Evaluation of Innovative Techniques in Medicine
Conditions:
Continence
Potency
Eligibility:
MALE
40-80 years
Phase:
PHASE2
PHASE3
Brief Summary
The investigators present a randomized trial of patients undergoing placement of dehydrated human amnion membrane (dHAM) around the neurovascular bundle (NVB) and vesicourethral anastomosis (VUA) duri...
Detailed Description
Patients suffer under incontinence and impotence after RRP, improving techniques and studies are missing. The human amniotic membrane includes growth factors and unique immune tolerance which can impr...
Eligibility Criteria
Inclusion
- patients with localized prostate cancer
- indication for radical prostatectomy
- no other treatment of prostate cancer
- availability to informed consent
Exclusion
- preoperative incontinence (24hrs pad-test)
- preoperative erectile dysfunction (IIEF-5 \< 20)
- metastasized or locally advanced prostate cancer in preoperative assessment
- previous radiation of pelvis
- previous prostate cancer therapy
- psychiatric disease
- participation at another study
Key Trial Info
Start Date :
April 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2025
Estimated Enrollment :
328 Patients enrolled
Trial Details
Trial ID
NCT03864939
Start Date
April 1 2019
End Date
April 1 2025
Last Update
March 6 2019
Active Locations (1)
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1
Department of Urology, Lukas Hospital
Neuss, Germany, 40464