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Post Operative RecoveryNCT05081232

Continence and Potency Following Multi-Layer Perinatal Issue alloGraft

A study testing MLG (Multi-Layered Perinatal Issue Allograft) Allograft in people with Post Operative Recovery, run by Wake Forest University Health Sciences.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 30 to 65 years, men only
Conditions the study is for
Post Operative Recovery
What is being tested?
MLG (Multi-Layered Perinatal Issue Allograft) Allograft
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Jan 2024to Aug 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 65 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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.

Who cannot join

  • 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
Show all 16Show fewer
  • 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)
  • Received administration of an investigational drug within 30 days prior to study, and/or has planned administration of another investigational product or procedure during participation in this study

About this study

Official title: Radical Prostectomy (RAP): Prospective Trial Evaluating Return to Continence and Potency Following Radical Prostatectomy Using Novel Multi-Layer Perinatal Issue alloGraft

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).

Read the detailed description

Participation in this study will involve MLG (Multi-Layered Perinatal Tissue Allograft) allograft, which is implanted during the surgery. This allograft is currently FDA approved and used for several type of surgeries.

The Multi-Layered Perinatal Tissue Allograft- (MLG) is processed from tissue according to the American Association of Tissue Banks (AATB) standards, and is regulated as a cell, tissue, or cellular or tissue-based product (HCT/P) under Section 361 of the Public Health Service Act. The grafts are distributed by Samaritan Biologics, LLC; an FDA-registered tissue bank.

The MLG allograft will be placed on each neurovascular bundle (NVB) bilaterally.

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.

Being tested
MLG (Multi-Layered Perinatal Issue Allograft) Allograft
Keywords
Multi-Layered Perinatal Tissue Allograft, Robot-Assisted Radical Prostatectomy, Erectile Dysfunction
Medical subject headings
Erectile Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MLG (Multi-Layered Perinatal Issue Allograft) AllograftDevice

    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.

Study groups in NCT05081232
Study groupRoleWhat they receive
Umbilical Cord Allograft RecipientsExperimentalMale patients undergoing Robot Assisted Radical Prostectomy with bilateral nerve sparing technique will remain eligible to receive allograft during the surgery.
Receives: Device: MLG (Multi-Layered Perinatal Issue Allograft) Allograft

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 1 month post-op

  2. 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)

    Measured: 3 month post-op

  3. 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)

    Measured: 6 month post-op

  4. 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)

    Measured: 12 month post-op

  5. Average time for return to continence

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

    Measured: 1-2 days post-op

  6. Average time for return to continence

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

    Measured: 1 month post-op

  7. Average time for return to continence

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

    Measured: 3 month post-op

  8. Average time for return to continence

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

    Measured: 6 month post-op

  9. Average time for return to continence

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

    Measured: 12 month post-op

Secondary outcomes (5)

  1. Expanded prostate cancer index composite-26 (EPIC-26) Score

    EPIC-26, contains five symptom domains (urinary incontinence, urinary irritative/obstructive, sexual, bowel, hormonal), scored from 0 (worst) to 100 (best)

    Measured: Months 1, 3, 6, and 12

  2. Abdominal VAS (Visual Analog Scale) Pain Score

    VAS score 0 -10: 0 indicating no abdominal pain to 10 as worst pain

    Measured: Post-op Days 1 and 2

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

    Twenty-five patients who underwent bilateral nerve sparing in the past matched by preoperative SHIM to see how they did in comparison to study cohort 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)

    Measured: Month 1 post-op

  4. Costs of prescription

    Oral Phosphodiesterase type 5 (PDE-5i), Intracavernosal injection, Alprostadil urethral suppository or future surgery (Inflatable penile prosthesis) to be recorded in the historical group of 25 patients. Overall expense will be measured by reviewing history. A market value of medication and treatment will be accounted. Post coverage out of pocket expense will not be reviewed separately.

    Measured: Month 12 post-op

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

    Overall patient satisfaction Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) - composed of 29 items - the survey contains 19 core questions about critical aspects of patients' hospital experiences (communication with nurses and doctors, the responsiveness of hospital staff, the cleanliness and quietness of the hospital environment, communication about medicines, discharge information, overall rating of hospital, and would they recommend the hospital) - HCAHPS score is accounted as The "top-box" score indicates how often patients selected the most positive response category when asked about their hospital experience. The higher a hospital's "top-box" score, the higher it ranks.

    Measured: Day 1 post-op

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2021
  2. Study startJan 2024 (estimated)
  3. Primary completionAug 2024 (estimated)
  4. Study completionAug 2024 (estimated)

Why it stopped: Study will not be conducted

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05081232
Sponsor's protocol ID
IRB00076844
Status last verified
Aug 2022
First submitted
4 Oct 2021
Last updated
1 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: De-Identified data from the study will be kept on password protected digital storage for at least three years following the project completion.

Publications

  • 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.

    PubMed 31136108

  • 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.

    PubMed 25959859

  • 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.

    PubMed 23551767

  • 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.

    PubMed 12226149

  • 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.

    PubMed 18354103

  • 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.

    PubMed 28965315

  • 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.

    PubMed 16280816

  • 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.

    PubMed 19250660

  • 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.

    PubMed 28656504

  • 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.

    PubMed 25613153

  • 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.

    PubMed 31782131

  • 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.

    PubMed 30209677

  • 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.

    PubMed 25876055

  • 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.

    PubMed 23902526

  • 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.

    PubMed 30199609

Questions about this trial

What is this clinical trial studying?

A study testing MLG (Multi-Layered Perinatal Issue Allograft) Allograft in people with Post Operative Recovery, run by Wake Forest University Health Sciences.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average time for return to potency (time frame: 1 month post-op). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05081232, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.

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