A Phase 2/3 interventional study of dHAM and No dHAM in Continence, Potency and Complication, sponsored by German Centre for Assessment and Evaluation of Innovative Techniques in Medicine. Not yet recruiting at 1 site in Germany. Open to male participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-03-06.
Sponsored by German Centre for Assessment and Evaluation of Innovative Techniques in Medicine · Phase 2/3, Interventional, and Prevention
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.
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.
4,279 studies on the registry are indexed under Recurrence; 988 are open to participants now.
This study's planned enrollment of 328 is above the median of 50 across 3,374 interventional studies indexed under Recurrence.
Browse Recurrence studies →This is the only study on the registry with German Centre for Assessment and Evaluation of Innovative Techniques in Medicine as lead sponsor.
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Exclusion Criteria:
dHAM wrap is placed during RRP.
Drug: dHAM
A standard RRP is performed.
Drug: No 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).
A standard radical retropubic prostatectomy (RRP) without dHAM is performed (Walsh, 2005).
Change in urine loss
Urine loss is assessed by 24 hrs pad-test (in gram)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: From baseline (1 week after surgery) to 12 months after surgery
Change in erectile function (EF)
EF is assessed by IIEF-5 (the International Index of Erectile Function) questionnaire.
Time frame: 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.
Time frame: 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.
Time frame: From baseline (4 weeks before surgery) to 12 months after surgery
Postoperative catheter removal
Time of postoperative catheter removal (days)
Time frame: through study completion, an average of 1 year
Complications
Complications are assessed according to Clavien-Dindo classification.
Time frame: perioperative, at 6 weeks, 3 months and 12 months
Biochemical recurrence
Measurement of prostate-specific antigen (PSA)
Time frame: at 6 weeks, 3 months and 12 months
Plan to share: No
This study is not yet recruiting, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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