Biochemical Recurrence, Complication, Continence, Potency
Conditions
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.
Interventions
DRUGdHAM
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).
DRUGNo dHAM
A standard radical retropubic prostatectomy (RRP) without dHAM is performed (Walsh, 2005).
Sponsors
German Centre for Assessment and Evaluation of Innovative Techniques in Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
Patients are blinded during the study period.
Eligibility
Sex/Gender
MALE
Age
40 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in urine loss | From baseline (1 week after surgery) to 3 weeks after surgery | Urine loss is assessed by 24 hrs pad-test (in gram) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in erectile function (EF) | From baseline (4 weeks before surgery) to 6 weeks after surgery | EF is assessed by IIEF-5 (the International Index of Erectile Function) questionnaire. |
| Postoperative catheter removal | through study completion, an average of 1 year | Time of postoperative catheter removal (days) |
| Complications | perioperative, at 6 weeks, 3 months and 12 months | Complications are assessed according to Clavien-Dindo classification. |
| Biochemical recurrence | at 6 weeks, 3 months and 12 months | Measurement of prostate-specific antigen (PSA) |
Countries
Germany
Contacts
Primary ContactDimitri Barski, PhD
Backup ContactThomas Otto, Prof
Outcome results
None listed