Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Continence and Potency Following Multi-Layer Perinatal Issue alloGraft

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05081232
Recruitment Status : Not yet recruiting
First Posted : October 18, 2021
Last Update Posted : April 27, 2022
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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).

Condition or disease Intervention/treatment Phase
Post Operative Recovery Device: MLG (Multi-Layered Perinatal Issue Allograft) Allograft Not Applicable

Detailed Description:

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

The 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Supportive Care
Official Title: RAP: Prospective Trial Evaluating Return to Continence and Potency Following Radical Prostatectomy Using Novel Multi-Layer Perinatal Issue alloGraft
Estimated Study Start Date : November 2022
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : November 2023

Arm Intervention/treatment
Experimental: Umbilical Cord Allograft Recipients
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

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.





Primary Outcome Measures :
  1. Average time for return to potency [ Time Frame: 1 month post-op ]
    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)

  2. Average time for return to potency [ Time Frame: 3 month post-op ]
    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. Average time for return to potency [ Time Frame: 6 month post-op ]
    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)

  4. Average time for return to potency [ Time Frame: 12 month post-op ]
    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)

  5. Average time for return to continence [ Time Frame: 1-2 days post-op ]
    Return to continence will be defined as use of < 1 pad post-RARP

  6. Average time for return to continence [ Time Frame: 1 month post-op ]
    Return to continence will be defined as use of < 1 pad post-RARP

  7. Average time for return to continence [ Time Frame: 3 month post-op ]
    Return to continence will be defined as use of < 1 pad post-RARP

  8. Average time for return to continence [ Time Frame: 6 month post-op ]
    Return to continence will be defined as use of < 1 pad post-RARP

  9. Average time for return to continence [ Time Frame: 12 month post-op ]
    Return to continence will be defined as use of < 1 pad post-RARP


Secondary Outcome Measures :
  1. Expanded prostate cancer index composite-26 (EPIC-26) Score [ Time Frame: Months 1, 3, 6, and 12 ]
    EPIC-26, contains five symptom domains (urinary incontinence, urinary irritative/obstructive, sexual, bowel, hormonal), scored from 0 (worst) to 100 (best)

  2. Abdominal VAS (Visual Analog Scale) Pain Score [ Time Frame: Post-op Days 1 and 2 ]
    VAS score 0 -10: 0 indicating no abdominal pain to 10 as worst pain

  3. Value analysis for a historical subset of patients who underwent same surgery as sexual health inventory for men (SHIM)-matched controls [ Time Frame: Month 1 post-op ]
    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)

  4. Costs of prescription [ Time Frame: Month 12 post-op ]
    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.

  5. Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) scores [ Time Frame: Day 1 post-op ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Male patients with Prostate Cancer
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. High-risk cancer planned for neoadjuvant therapy, full or partial excision of neurovascular bundles
  2. Is unable to comply with learning and documenting penile rehabilitation, including oral 5-phosphodiesterase inhibitor use, vacuum pump therapy use, and/or injectable medications
  3. 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
  4. Patients that have had prior hormonal therapy such as Lupron or oral anti-androgens
  5. Patients with poor urinary control at baseline requiring the use of pads for leakage
  6. Previous history of pelvic radiation
  7. Previous history of simple prostatectomy or transurethral prostate surgery
  8. Patients with obesity defined as BMI > 40 kg/m2
  9. History of open pelvic surgery within 5 years except for hernia repair
  10. Poorly controlled diabetes (A1C >8.5%)
  11. Scheduled at the time of screening to undergo chemotherapy, radiation, hormone therapy, or open surgery during the study period
  12. Any neurologic disorder or psychiatric disorder that might confound postsurgical assessments
  13. 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
  14. In the opinion of the PI, has a history of drug or alcohol abuse within last 12 months
  15. Is allergic to Aminoglycoside antibiotics (such as Gentamicin and/or Streptomycin)
  16. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05081232


Contacts
Layout table for location contacts
Contact: Sachin N Vyas, MS, PhD 336-713-4098 svyas@wakehealth.edu

Locations
Layout table for location information
United States, North Carolina
Wake Forest Health Sciences
Winston-Salem, North Carolina, United States, 27157
Contact: Sachin N Vyas, MS,PhD    336-713-4098    svyas@wakehealth.edu   
Principal Investigator: Ram A Pathak, MD         
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
Layout table for investigator information
Principal Investigator: Ram A Pathak, MD Assistant Professor of Urology
Publications:

Layout table for additonal information
Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT05081232    
Other Study ID Numbers: IRB00076844
First Posted: October 18, 2021    Key Record Dates
Last Update Posted: April 27, 2022
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-Identified data from the study will be kept on password protected digital storage for at least three years following the project completion.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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)

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Wake Forest University Health Sciences:
Multi-Layered Perinatal Tissue Allograft
Robot-Assisted Radical Prostatectomy
Erectile Dysfunction