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

NCT03864939 | Unknown Phase 2 DMC

• 1 other identifier: HAM01
• Study Type: interventional
• Target: 328
• Locations: 1 country
• Sites: 1

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.

Conditions

Continence; Potency; Complication; Biochemical Recurrence

Outcome Measures

Primary Outcomes (4)

• Change in urine loss

  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

  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

  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

  Urine loss is assessed by 24 hrs pad-test (in gram)

  From baseline (1 week after surgery) to 12 months after surgery

Secondary Outcomes (6)

• Change in erectile function (EF)

  From baseline (4 weeks before surgery) to 6 weeks after surgery

• Change in erectile function (EF)

  From baseline (4 weeks before surgery) to 3 months after surgery

• Change in erectile function (EF)

  From baseline (4 weeks before surgery) to 12 months after surgery

• Postoperative catheter removal

  through study completion, an average of 1 year

• Complications

  perioperative, at 6 weeks, 3 months and 12 months

Study Arms (2)

dHAM

EXPERIMENTAL

dHAM wrap is placed during RRP.

Drug: dHAM

Standard

PLACEBO COMPARATOR

A standard RRP is performed.

Drug: No dHAM

Interventions

dHAM DRUG

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).

dHAM

No dHAM DRUG

A standard radical retropubic prostatectomy (RRP) without dHAM is performed (Walsh, 2005).

Standard

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with localized prostate cancer
• indication for radical prostatectomy
• no other treatment of prostate cancer
• availability to informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• German Centre for Assessment and Evaluation of Innovative Techniques in Medicine: lead

Study Sites (1)

Department of Urology, Lukas Hospital

Neuss, 40464, Germany

Location

Related Publications (16)

• Abrams P, Andersson KE, Apostolidis A, Birder L, Bliss D, Brubaker L, Cardozo L, Castro-Diaz D, O'Connell PR, Cottenden A, Cotterill N, de Ridder D, Dmochowski R, Dumoulin C, Fader M, Fry C, Goldman H, Hanno P, Homma Y, Khullar V, Maher C, Milsom I, Newman D, Nijman RJM, Rademakers K, Robinson D, Rosier P, Rovner E, Salvatore S, Takeda M, Wagg A, Wagner T, Wein A; members of the committees. 6th International Consultation on Incontinence. Recommendations of the International Scientific Committee: EVALUATION AND TREATMENT OF URINARY INCONTINENCE, PELVIC ORGAN PROLAPSE AND FAECAL INCONTINENCE. Neurourol Urodyn. 2018 Sep;37(7):2271-2272. doi: 10.1002/nau.23551. Epub 2018 Aug 14. No abstract available.

  PMID: 30106223 BACKGROUND

• Asimakopoulos AD, Miano R, Galfano A, Bocciardi AM, Vespasiani G, Spera E, Gaston R. Retzius-sparing robot-assisted laparoscopic radical prostatectomy: Critical appraisal of the anatomic landmarks for a complete intrafascial approach. Clin Anat. 2015 Oct;28(7):896-902. doi: 10.1002/ca.22576. Epub 2015 Jul 21.

  PMID: 26194970 BACKGROUND

• Barski D, Gerullis H, Ecke T, Varga G, Boros M, Pintelon I, Timmermans JP, Otto T. Human Amniotic Membrane Is Not Suitable for the Grafting of Colon Lesions and Prevention of Adhesions in a Xenograft Rat Model. Surg Innov. 2017 Aug;24(4):313-320. doi: 10.1177/1553350617709828. Epub 2017 May 26.

  PMID: 28548553 BACKGROUND

• Barski D, Gerullis H, Ecke T, Varga G, Boros M, Pintelon I, Timmermans JP, Otto T. Human amniotic membrane dressing for the treatment of an infected wound due to an entero-cutaneous fistula: Case report. Int J Surg Case Rep. 2018;51:11-13. doi: 10.1016/j.ijscr.2018.08.015. Epub 2018 Aug 13.

  PMID: 30130666 BACKGROUND

• Barski D, Gerullis H, Ecke T, Varga G, Boros M, Pintelon I, Timmermans JP, Winter A, Bagner JW, Otto T. Repair of a vesico-vaginal fistula with amniotic membrane - Step 1 of the IDEAL recommendations of surgical innovation. Cent European J Urol. 2015;68(4):459-61. doi: 10.5173/ceju.2015.683. Epub 2015 Nov 13.

  PMID: 26855802 BACKGROUND

• Barski D, Gerullis H, Ecke T, Yang J, Varga G, Boros M, Pintelon I, Timmermans JP, Otto T. Bladder Reconstruction with Human Amniotic Membrane in a Xenograft Rat Model: A Preclinical Study. Int J Med Sci. 2017 Mar 11;14(4):310-318. doi: 10.7150/ijms.18127. eCollection 2017.

  PMID: 28553162 BACKGROUND

• Capogrosso P, Salonia A, Briganti A, Montorsi F. Postprostatectomy Erectile Dysfunction: A Review. World J Mens Health. 2016 Aug;34(2):73-88. doi: 10.5534/wjmh.2016.34.2.73. Epub 2016 Aug 23.

  PMID: 27574591 BACKGROUND

• D'Amico AV, Whittington R, Malkowicz SB, Schultz D, Blank K, Broderick GA, Tomaszewski JE, Renshaw AA, Kaplan I, Beard CJ, Wein A. Biochemical outcome after radical prostatectomy, external beam radiation therapy, or interstitial radiation therapy for clinically localized prostate cancer. JAMA. 1998 Sep 16;280(11):969-74. doi: 10.1001/jama.280.11.969.

  PMID: 9749478 BACKGROUND

• Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.

  PMID: 15273542 BACKGROUND

• Lemke A, Ferguson J, Gross K, Penzenstadler C, Bradl M, Mayer RL, Gerner C, Redl H, Wolbank S. Transplantation of human amnion prevents recurring adhesions and ameliorates fibrosis in a rat model of sciatic nerve scarring. Acta Biomater. 2018 Jan 15;66:335-349. doi: 10.1016/j.actbio.2017.11.042. Epub 2017 Nov 28.

  PMID: 29191510 BACKGROUND

• Ogaya-Pinies G, Kadakia Y, Palayapalayam-Ganapathi H, Woodlief T, Jenson C, Syed J, Patel V. Use of Scaffolding Tissue Biografts To Bolster Vesicourethral Anastomosis During Salvage Robot-assisted Prostatectomy Reduces Leak Rates and Catheter Times. Eur Urol. 2018 Jul;74(1):92-98. doi: 10.1016/j.eururo.2016.10.004. Epub 2016 Oct 14.

  PMID: 27751731 BACKGROUND

• Ogaya-Pinies G, Palayapalam-Ganapathi H, Rogers T, Hernandez-Cardona E, Rocco B, Coelho RF, Jenson C, Patel VR. Can dehydrated human amnion/chorion membrane accelerate the return to potency after a nerve-sparing robotic-assisted radical prostatectomy? Propensity score-matched analysis. J Robot Surg. 2018 Jun;12(2):235-243. doi: 10.1007/s11701-017-0719-8. Epub 2017 Jun 27.

  PMID: 28656504 BACKGROUND

• Patel VR, Samavedi S, Bates AS, Kumar A, Coelho R, Rocco B, Palmer K. Dehydrated Human Amnion/Chorion Membrane Allograft Nerve Wrap Around the Prostatic Neurovascular Bundle Accelerates Early Return to Continence and Potency Following Robot-assisted Radical Prostatectomy: Propensity Score-matched Analysis. Eur Urol. 2015 Jun;67(6):977-980. doi: 10.1016/j.eururo.2015.01.012. Epub 2015 Jan 19.

  PMID: 25613153 BACKGROUND

• Rosen RC, Riley A, Wagner G, Osterloh IH, Kirkpatrick J, Mishra A. The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Urology. 1997 Jun;49(6):822-30. doi: 10.1016/s0090-4295(97)00238-0.

  PMID: 9187685 BACKGROUND

• Walsh PC. Re: Anatomical radical retropubic prostatectomy: detailed description of the surgical technique. J Urol. 2005 Jan;173(1):324. doi: 10.1097/01.ju.0000148246.73337.ad. No abstract available.

  PMID: 15592108 BACKGROUND

• Barski D, Gerullis H, Ecke T, Boros M, Brune J, Beutner U, Tsaur I, Ramon A, Otto T. Application of Dried Human Amnion Graft to Improve Post-Prostatectomy Incontinence and Potency: A Randomized Exploration Study Protocol. Adv Ther. 2020 Jan;37(1):592-602. doi: 10.1007/s12325-019-01158-3. Epub 2019 Nov 28.

  PMID: 31782131 DERIVED

Related Links

• Abrams P, Cardozo L, Khoury S, Wein A. 2005. Incontinence Basics\& Evaluation, 3rd International Consultation on Incontinence. Chapter 13: Imaging and other Investigations.

Study Officials

• Dimitri Barski, PhD

  Department of Urology, Lukas Hospital Neuss

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dimitri Barski, PhD

CONTACT

004921318882401; dbarski@lukasneuss.de

Thomas Otto, Prof

CONTACT

004921318882401; totto@lukasneuss.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients are blinded during the study period.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 3, 2019
• First Posted: March 6, 2019
• Study Start: April 1, 2019
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2025
• Last Updated: March 6, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)