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

• Status: Not yet recruiting
• Trial end date: 2025-04-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• patients with localized prostate cancer

• indication for radical prostatectomy

• no other treatment of prostate cancer

• availability to informed consent

Exclusion Criteria:

• 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