Randomized Pilot Study to Improve Postprostatectomy Incontinence and Potency by Application of Dried Human Amnion Graft
Overview
- Phase
- Phase 2
- Intervention
- dHAM
- Conditions
- Continence
- Sponsor
- German Centre for Assessment and Evaluation of Innovative Techniques in Medicine
- Enrollment
- 328
- Locations
- 1
- Primary Endpoint
- Change in urine loss
- Status
- Not yet recruiting
- Last Updated
- 7 years ago
Overview
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.
Investigators
Dimitri Barski
Principal Investigator
Lukas-Krankenhaus GmbH
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
Arms & Interventions
dHAM
dHAM wrap is placed during RRP.
Intervention: dHAM
Standard
A standard RRP is performed.
Intervention: No dHAM
Outcomes
Primary Outcomes
Change in urine loss
Time Frame: From baseline (1 week after surgery) to 12 months after surgery
Urine loss is assessed by 24 hrs pad-test (in gram)
Secondary Outcomes
- Biochemical recurrence(at 6 weeks, 3 months and 12 months)
- Change in erectile function (EF)(From baseline (4 weeks before surgery) to 12 months after surgery)
- Complications(perioperative, at 6 weeks, 3 months and 12 months)
- Postoperative catheter removal(through study completion, an average of 1 year)