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

March 5, 2019 updated by: Dimitri Barski, German Centre for Assessment and Evaluation of Innovative Techniques in Medicine

Randomized Pilot Study to Improve Postprostatectomy Incontinence and Potency by Application of Dried Human Amnion Graft

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

328

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Neuss, Germany, 40464
        • Department of Urology, Lukas Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: dHAM
dHAM wrap is placed during RRP.
Drug: 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).
Placebo Comparator: Standard
A standard RRP is performed.
Drug: No dHAM
A standard radical retropubic prostatectomy (RRP) without dHAM is performed (Walsh, 2005).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in urine loss
Time Frame: From baseline (1 week after surgery) to 3 weeks after surgery
Urine loss is assessed by 24 hrs pad-test (in gram)
From baseline (1 week after surgery) to 3 weeks after surgery
Change in urine loss
Time Frame: From baseline (1 week after surgery) to 6 weeks after surgery
Urine loss is assessed by 24 hrs pad-test (in gram)
From baseline (1 week after surgery) to 6 weeks after surgery
Change in urine loss
Time Frame: From baseline (1 week after surgery) to 3 months after surgery
Urine loss is assessed by 24 hrs pad-test (in gram)
From baseline (1 week after surgery) to 3 months after surgery
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)
From baseline (1 week after surgery) to 12 months after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

German Centre for Assessment and Evaluation of Innovative Techniques in Medicine

Investigators

  • Principal Investigator: Dimitri Barski, PhD, Department of Urology, Lukas Hospital Neuss

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2019

Primary Completion (Anticipated)

April 1, 2024

Study Completion (Anticipated)

April 1, 2025

Study Registration Dates

First Submitted

March 3, 2019

First Submitted That Met QC Criteria

March 5, 2019

First Posted (Actual)

March 6, 2019

Study Record Updates

Last Update Posted (Actual)

March 6, 2019

Last Update Submitted That Met QC Criteria

March 5, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HAM01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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