Clinical trial NCT03864939: Application of Dried Human Amnion Graft to Improve Postprostatectomy Incontinence and Potency
Official title: Randomized Pilot Study to Improve Postprostatectomy Incontinence and Potency by Application of Dried Human Amnion Graft
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Continence
Potency
Complication
Biochemical Recurrence
Lead sponsor: German Centre for Assessment and Evaluation of Innovative Techniques in Medicine
Sponsor class: OTHER
First posted: 2019-03-06
Enrollment: 328
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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) 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.

Eligibility 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

Primary outcomes:
measure: Change in urine loss
timeFrame: From baseline (1 week after surgery) to 3 weeks after surgery
measure: Change in urine loss
timeFrame: From baseline (1 week after surgery) to 6 weeks after surgery
measure: Change in urine loss
timeFrame: From baseline (1 week after surgery) to 3 months after surgery
measure: Change in urine loss
timeFrame: From baseline (1 week after surgery) to 12 months after surgery
Secondary outcomes:
measure: Change in erectile function (EF)
timeFrame: From baseline (4 weeks before surgery) to 6 weeks after surgery
measure: Change in erectile function (EF)
timeFrame: From baseline (4 weeks before surgery) to 3 months after surgery
measure: Change in erectile function (EF)
timeFrame: From baseline (4 weeks before surgery) to 12 months after surgery
measure: Postoperative catheter removal
timeFrame: through study completion, an average of 1 year
measure: Complications
timeFrame: perioperative, at 6 weeks, 3 months and 12 months
measure: Biochemical recurrence
timeFrame: at 6 weeks, 3 months and 12 months
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: Department of Urology, Lukas Hospital
Study officials:
affiliation: Department of Urology, Lukas Hospital Neuss
name: Dimitri Barski, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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