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

Phase 2

Not yet recruiting

• Conditions: Continence; Potency; Complication; Biochemical Recurrence
• Interventions: Drug: No dHAM; Drug: dHAM

• Registration Number: NCT03864939
• Lead Sponsor: German Centre for Assessment and Evaluation of Innovative Techniques in Medicine

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.

Study Timeline

• Status Verified: 2019-03
• Study First Submitted: 2019-03-03
• Study First Submitted QC: 2019-03-05
• Last Update Submitted: 2019-03-05
• Study First Posted: 2019-03-06
• Last Update Posted: 2019-03-06
• Study Start: 2019-04-01
• Primary Completion: 2024-04-01
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 328

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard	No dHAM	A standard RRP is performed.
dHAM	dHAM	dHAM wrap is placed during RRP.

Primary Outcome Measures

Name	Time	Method
Change in urine loss	From baseline (1 week after surgery) to 12 months after surgery	Urine loss is assessed by 24 hrs pad-test (in gram)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Urology, Lukas Hospital; 🇩🇪 Neuss, Germany