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

Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03864939
• Other study ID #: HAM01
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: April 1, 2019
• Est. completion date: April 1, 2025

Study information

• Verified date: March 2019
• Source: German Centre for Assessment and Evaluation of Innovative Techniques in Medicine
• Contact: Dimitri Barski, PhD
• Phone: 004921318882401
• Email: dbarski[@]lukasneuss.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 328
• Est. completion date: April 1, 2025
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Biochemical Recurrence
• Complication
• Continence
• Potency
• Recurrence

Intervention

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).
• No dHAM
A standard radical retropubic prostatectomy (RRP) without dHAM is performed (Walsh, 2005).

Locations

Country	Name	City	State
Germany	Department of Urology, Lukas Hospital	Neuss

Sponsors (1)

Lead Sponsor	Collaborator
German Centre for Assessment and Evaluation of Innovative Techniques in Medicine

Country where clinical trial is conducted

Germany, 

References & Publications (15)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Walsh PC. Re: Anatomical radical retropubic prostatectomy: detailed description of the surgical technique. J Urol. 2005 Jan;173(1):324. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

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

External Links

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