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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Continence, Potency, Complication, Biochemical Recurrence

Intervention / Treatment
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* Drug: dHAM
* Drug: No dHAM


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dHAM<br>dHAM wrap is placed during RRP. | Drug: dHAM<br>* 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).<br>|
| Placebo Comparator: Standard<br>A standard RRP is performed. | Drug: No dHAM<br>* A standard radical retropubic prostatectomy (RRP) without dHAM is performed (Walsh, 2005).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in urine loss | Urine loss is assessed by 24 hrs pad-test (in gram) | From baseline (1 week after surgery) to 3 weeks after surgery | 
| Change in urine loss | Urine loss is assessed by 24 hrs pad-test (in gram) | From baseline (1 week after surgery) to 6 weeks after surgery | 
| Change in urine loss | Urine loss is assessed by 24 hrs pad-test (in gram) | From baseline (1 week after surgery) to 3 months after surgery | 
| Change in urine loss | Urine loss is assessed by 24 hrs pad-test (in gram) | From baseline (1 week after surgery) to 12 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in erectile function (EF) | EF is assessed by IIEF-5 (the International Index of Erectile Function) questionnaire. | From baseline (4 weeks before surgery) to 6 weeks after surgery | 
| Change in erectile function (EF) | EF is assessed by IIEF-5 (the International Index of Erectile Function) questionnaire. | From baseline (4 weeks before surgery) to 3 months after surgery | 
| Change in erectile function (EF) | EF is assessed by IIEF-5 (the International Index of Erectile Function) questionnaire. | From baseline (4 weeks before surgery) to 12 months after surgery | 
| Postoperative catheter removal | Time of postoperative catheter removal (days) | through study completion, an average of 1 year | 
| Complications | Complications are assessed according to Clavien-Dindo classification. | perioperative, at 6 weeks, 3 months and 12 months | 
| Biochemical recurrence | Measurement of prostate-specific antigen (PSA) | at 6 weeks, 3 months and 12 months |