NCT03864939

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

Randomized Pilot Study to Improve Postprostatectomy Incontinence and Potency by Application of Dried Human Amnion Graft

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 328 (estimated)
• Sponsor: German Centre for Assessment and Evaluation of Innovative Techniques in Medicine · Academic / Other
• Sex: Male
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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 improve tissue regeneration. The preliminary studies could prove the potential value of dHAM in the reconstruction of the urinary tract and nerve protection. The investigators initially present a randomized trial to improve postoperative continence and potency of patients undergoing placement of dehydrated human amnion membrane (dHAM) around the neurovascular bundle (NVB) and vesicourethral anastomosis (VUA) during RRP for the treatment of prostate cancer. RRP is performed in a standardized way by one experienced surgeon. The patients are randomized 1:1 to dHAM vs. placebo and blinded during the study period. The primary outcome is a postoperative continence measure as 24hrs pad test up to 12mos postoperatively. Secondary outcomes are potency, insufficiency of VUA, postoperative complications and biochemical recurrence. Using the T-test with an alpha of 0.05 and a power of 80% and expecting a drop-out of 20% of the patients, an adjusted sample size per arm of 164 patients is required.

Conditions

• Continence
• Potency
• Complication
• Biochemical Recurrence

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2019-04-01
• Primary completion: 2024-04-01
• Completion: 2025-04-01
• First posted: 2019-03-06
• Last updated: 2019-03-06

Locations

1 site across 1 country: Germany