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Application of Dried Human Amnion Graft to Improve Postprostatectomy Incontinence and Potency

NCT03864939 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 328

Last updated 2019-03-06

No results posted yet for this study

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) during radical retropubic prostatectomy (RRP) in a tertiary center in Germany.

Conditions

  • Continence
  • Potency
  • Complication
  • Biochemical Recurrence

Interventions

DRUG

dHAM

A dehydrated human amnion membrane (dHAM, 1x3cm) is placed around the neurovascular bundle (NVB) on the left and right side and vesicourethral anastomosis (VUA) during radical retropubic prostatectomy (RRP).

DRUG

No dHAM

A standard radical retropubic prostatectomy (RRP) without dHAM is performed (Walsh, 2005).

Sponsors & Collaborators

  • German Centre for Assessment and Evaluation of Innovative Techniques in Medicine

    lead OTHER

Principal Investigators

  • Dimitri Barski, PhD · Department of Urology, Lukas Hospital Neuss

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2024-04-01
Completion
2025-04-01

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03864939 on ClinicalTrials.gov