Continence and Potency Following Multi-Layer Perinatal Issue alloGraft

NCT05081232 | Withdrawn FDA Device

• 1 other identifier: IRB00076844
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this research is to determine the effectiveness of using human Umbilical Cord (UC) allograft to help improve return to erectile function and bladder control in patients following robot-assisted radical prostatectomy (RARP).

Conditions

Post Operative Recovery

Keywords

Multi-Layered Perinatal Tissue Allograft; Robot-Assisted Radical Prostatectomy; Erectile Dysfunction

Outcome Measures

Primary Outcomes (9)

• Average time for return to potency

  Early recovery in potency will be measured as + 4 points of total Sexual Health Inventory for Men (SHIM) score in relation to baseline score. Return to potency will be defined as the ability to achieve an erection sufficient for intercourse more than 50% of the time or at least 50% rigidity post-robot-assisted radical prostatectomy (RARP) (Tool: SHIM, Q2 \> 3)

  1 month post-op

• Average time for return to potency

  Early recovery in potency will be measured as + 4 points of total SHIM score in relation to baseline score. Return to potency will be defined as the ability to achieve an erection sufficient for intercourse more than 50% of the time or at least 50% rigidity post-RARP (Tool: SHIM, Q2 \> 3)

  3 month post-op

• Average time for return to potency

  Early recovery in potency will be measured as + 4 points of total SHIM score in relation to baseline score. Return to potency will be defined as the ability to achieve an erection sufficient for intercourse more than 50% of the time or at least 50% rigidity post-RARP (Tool: SHIM, Q2 \> 3)

  6 month post-op

• Average time for return to potency

  Early recovery in potency will be measured as + 4 points of total SHIM score in relation to baseline score. Return to potency will be defined as the ability to achieve an erection sufficient for intercourse more than 50% of the time or at least 50% rigidity post-RARP (Tool: SHIM, Q2 \> 3)

  12 month post-op

• Average time for return to continence

  Return to continence will be defined as use of \< 1 pad post-RARP

  1-2 days post-op

• Average time for return to continence

  Return to continence will be defined as use of \< 1 pad post-RARP

  1 month post-op

• Average time for return to continence

  Return to continence will be defined as use of \< 1 pad post-RARP

  3 month post-op

• Average time for return to continence

  Return to continence will be defined as use of \< 1 pad post-RARP

  6 month post-op

• Average time for return to continence

  Return to continence will be defined as use of \< 1 pad post-RARP

  12 month post-op

Secondary Outcomes (5)

• Expanded prostate cancer index composite-26 (EPIC-26) Score

  Months 1, 3, 6, and 12

• Abdominal VAS (Visual Analog Scale) Pain Score

  Post-op Days 1 and 2

• Value analysis for a historical subset of patients who underwent same surgery as sexual health inventory for men (SHIM)-matched controls

  Month 1 post-op

• Costs of prescription

  Month 12 post-op

• Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) scores

  Day 1 post-op

Study Arms (1)

Umbilical Cord Allograft Recipients

EXPERIMENTAL

Male patients undergoing Robot Assisted Radical Prostectomy with bilateral nerve sparing technique will remain eligible to receive allograft during the surgery.

Device: MLG (Multi-Layered Perinatal Issue Allograft) Allograft

Interventions

MLG (Multi-Layered Perinatal Issue Allograft) Allograft DEVICE

MLG allografts contains more than 450 bioactive proteins including growth factors and cytokines known to modulate inflammation and promote tissue healing. MLG is supplied as sterile sheets having dimensions of 2cm x 2cm and a thickness of approximately 0.8-1.0mm thick. Participants receiving MLG will have it placed around the neurovascular bundle. Placement of the graft should not take over 5 minutes of time to impact overall surgical time length significantly.

Umbilical Cord Allograft Recipients

Eligibility Criteria

• Age: 30 Years - 65 Years
• Gender Eligibility Details: Male patients with Prostate Cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male subjects with at least age of 30 to 65
• Primary diagnosis of prostate cancer selected for surgical intervention (Radical Prostatectomy)
• Primary diagnosis of organ confined untreated prostate cancer
• Planned elective radical prostatectomy with bilateral nerve sparing technique
• Negative urinalysis within 30 days prior to date of surgery
• Patient has no erectile dysfunction (SHIM Score \< 14 ) prior to date of surgery
• Patient has the willingness to comply with instruction of the investigator
• Patient has the willingness to comply with follow-up surveys
• Have ability to provide full written consent.

You may not qualify if:

• High-risk cancer planned for neoadjuvant therapy, full or partial excision of neurovascular bundles
• Is unable to comply with learning and documenting penile rehabilitation, including oral 5-phosphodiesterase inhibitor use, vacuum pump therapy use, and/or injectable medications
• Patients with a history of more than two weeks treatment with immuno-suppressants (including systemic corticosteroids), cytotoxic chemotherapy within one month prior to initial screening, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study
• Patients that have had prior hormonal therapy such as Lupron or oral anti-androgens
• Patients with poor urinary control at baseline requiring the use of pads for leakage
• Previous history of pelvic radiation
• Previous history of simple prostatectomy or transurethral prostate surgery
• Patients with obesity defined as BMI \> 40 kg/m2
• History of open pelvic surgery within 5 years except for hernia repair
• Poorly controlled diabetes (A1C \>8.5%)
• Scheduled at the time of screening to undergo chemotherapy, radiation, hormone therapy, or open surgery during the study period
• Any neurologic disorder or psychiatric disorder that might confound postsurgical assessments
• Has any condition(s), which seriously compromises the subject's ability to participate in this study, sign consent, or has a known history of poor adherence with medical treatment
• In the opinion of the PI, has a history of drug or alcohol abuse within last 12 months
• Is allergic to Aminoglycoside antibiotics (such as Gentamicin and/or Streptomycin)

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Related Publications (15)

• Neumaier MF, Segall CH Junior, Hisano M, Rocha FET, Arap S, Arap MA. Factors affecting urinary continence and sexual potency recovery after robotic-assisted radical prostatectomy. Int Braz J Urol. 2019 Jul-Aug;45(4):703-712. doi: 10.1590/S1677-5538.IBJU.2018.0704.

  PMID: 31136108 BACKGROUND

• Carlsson S, Drevin L, Loeb S, Widmark A, Lissbrant IF, Robinson D, Johansson E, Stattin P, Fransson P. Population-based study of long-term functional outcomes after prostate cancer treatment. BJU Int. 2016 Jun;117(6B):E36-45. doi: 10.1111/bju.13179. Epub 2015 Jun 23.

  PMID: 25959859 BACKGROUND

• Nelson CJ, Scardino PT, Eastham JA, Mulhall JP. Back to baseline: erectile function recovery after radical prostatectomy from the patients' perspective. J Sex Med. 2013 Jun;10(6):1636-43. doi: 10.1111/jsm.12135. Epub 2013 Apr 3.

  PMID: 23551767 BACKGROUND

• Steineck G, Helgesen F, Adolfsson J, Dickman PW, Johansson JE, Norlen BJ, Holmberg L; Scandinavian Prostatic Cancer Group Study Number 4. Quality of life after radical prostatectomy or watchful waiting. N Engl J Med. 2002 Sep 12;347(11):790-6. doi: 10.1056/NEJMoa021483.

  PMID: 12226149 BACKGROUND

• Sanda MG, Dunn RL, Michalski J, Sandler HM, Northouse L, Hembroff L, Lin X, Greenfield TK, Litwin MS, Saigal CS, Mahadevan A, Klein E, Kibel A, Pisters LL, Kuban D, Kaplan I, Wood D, Ciezki J, Shah N, Wei JT. Quality of life and satisfaction with outcome among prostate-cancer survivors. N Engl J Med. 2008 Mar 20;358(12):1250-61. doi: 10.1056/NEJMoa074311.

  PMID: 18354103 BACKGROUND

• Castiglione F, Ralph DJ, Muneer A. Surgical Techniques for Managing Post-prostatectomy Erectile Dysfunction. Curr Urol Rep. 2017 Sep 30;18(11):90. doi: 10.1007/s11934-017-0735-2.

  PMID: 28965315 BACKGROUND

• Menon M, Kaul S, Bhandari A, Shrivastava A, Tewari A, Hemal A. Potency following robotic radical prostatectomy: a questionnaire based analysis of outcomes after conventional nerve sparing and prostatic fascia sparing techniques. J Urol. 2005 Dec;174(6):2291-6, discussion 2296. doi: 10.1097/01.ju.0000181825.54480.eb.

  PMID: 16280816 BACKGROUND

• Finley DS, Osann K, Skarecky D, Ahlering TE. Hypothermic nerve-sparing radical prostatectomy: rationale, feasibility, and effect on early continence. Urology. 2009 Apr;73(4):691-6. doi: 10.1016/j.urology.2008.09.085. Epub 2009 Feb 28.

  PMID: 19250660 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

• 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 BACKGROUND

• Razdan S, Bajpai RR, Razdan S, Sanchez MA. A matched and controlled longitudinal cohort study of dehydrated human amniotic membrane allograft sheet used as a wraparound nerve bundles in robotic-assisted laparoscopic radical prostatectomy: a puissant adjunct for enhanced potency outcomes. J Robot Surg. 2019 Jun;13(3):475-481. doi: 10.1007/s11701-018-0873-7. Epub 2018 Sep 12.

  PMID: 30209677 BACKGROUND

• Fetterolf DE, Snyder RJ. Scientific and clinical support for the use of dehydrated amniotic membrane in wound management. Wounds. 2012 Oct;24(10):299-307.

  PMID: 25876055 BACKGROUND

• Koob TJ, Rennert R, Zabek N, Massee M, Lim JJ, Temenoff JS, Li WW, Gurtner G. Biological properties of dehydrated human amnion/chorion composite graft: implications for chronic wound healing. Int Wound J. 2013 Oct;10(5):493-500. doi: 10.1111/iwj.12140. Epub 2013 Aug 1.

  PMID: 23902526 BACKGROUND

• Bullard JD, Lei J, Lim JJ, Massee M, Fallon AM, Koob TJ. Evaluation of dehydrated human umbilical cord biological properties for wound care and soft tissue healing. J Biomed Mater Res B Appl Biomater. 2019 May;107(4):1035-1046. doi: 10.1002/jbm.b.34196. Epub 2018 Sep 10.

  PMID: 30199609 BACKGROUND

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Transplantation, Homologous

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative

Study Officials

• Ram A Pathak, MD

  Assistant Professor of Urology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Male patients undergoing Robot-Assisted Radical Prostectomy and eligible will receive Human Umbilical Cord (UC) allograft. It is hypothesized that patients receiving UC allograft placed around the neurovascular bundle will facilitate earlier return to potency and continence compared to those that do not receive UC allografts.

Study Record Dates

• First Submitted: October 4, 2021
• First Posted: October 18, 2021
• Study Start: January 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: August 1, 2023

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: At least 3 years from study completion
• Access Criteria: Contact the principal investigator (Dr. Ram Anil Pathak) or project manager (Sachin Nalin Vyas, MS,PhD)