Back to resultsThe Ability of Adipose Flap Over the NVB to Improve Sexual and Urinary Function Following Radical Prostatectomy
Primary Purpose
Prostate Cancer, Erectile Dysfunction, Urinary Incontinence
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Technical modification during radical prostatectomy
Sponsored by
About this trial
This is an interventional other trial for Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
- Male aged 18 years and older.
- Patients diagnosed with prostate cancer.
- Patients should be potent (IIEF erectile function domain score of 26 and above) and have a sexual partner.
- Patients scheduled for Radical Prostatectomy with NVB preservation (at least unilateral).
Exclusion Criteria:
Patients who did not undergo NVB preservation or technical inability to create flap
Sites / Locations
- Rabin Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Adipose Flap
Control
Arm Description
Covering neurovascular bundle with fat
No adipose flap
Outcomes
Primary Outcome Measures
Erectile function
IIEF erectile function score
Secondary Outcome Measures
Continence status
King's Health Questionnaire score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04577222
Brief Title
The Ability of Adipose Flap Over the NVB to Improve Sexual and Urinary Function Following Radical Prostatectomy
Official Title
The Ability of Adipose Flap Over the NVB to Improve Sexual and Urinary Function Following Radical Prostatectomy; a Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 15, 2018 (Actual)
Primary Completion Date
April 15, 2022 (Anticipated)
Study Completion Date
July 15, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rabin Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Despite technological advances, incontinence and impotence remain significant side effects of radical prostatectomy (RP). Strategies have been developed to reduce the injury to the erection nerves (i.e. neurovascular bundle - NVB)during surgery to further improve functional outcomes after RP. Adipose tissue is known for its stabilizing and even healing potential. These features include reducing the inflammatory process and improving blood supply to an injured nerve. We hypothesized that covering the NVB with periprostatic fat during surgery may potentially improve neural recovery and enhance functional recovery after RP. We sought to examine our hypothesis in a randomized controlled trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Erectile Dysfunction, Urinary Incontinence
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Adipose Flap
Arm Type
Experimental
Arm Description
Covering neurovascular bundle with fat
Arm Title
Control
Arm Type
No Intervention
Arm Description
No adipose flap
Intervention Type
Procedure
Intervention Name(s)
Technical modification during radical prostatectomy
Intervention Description
Covering the NVB with fat
Primary Outcome Measure Information:
Title
Erectile function
Description
IIEF erectile function score
Time Frame
Change from Baseline IIEF score at 12 months
Secondary Outcome Measure Information:
Title
Continence status
Description
King's Health Questionnaire score
Time Frame
Change from Baseline King's score at 12 months
10. Eligibility
Sex
Male
Gender Based
Yes
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male aged 18 years and older.
Patients diagnosed with prostate cancer.
Patients should be potent (IIEF erectile function domain score of 26 and above) and have a sexual partner.
Patients scheduled for Radical Prostatectomy with NVB preservation (at least unilateral).
Exclusion Criteria:
Patients who did not undergo NVB preservation or technical inability to create flap
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shay Golan, MD
Phone
+972507447573
Email
Shaygo1@gmail.com
Facility Information:
Facility Name
Rabin Medical Center
City
Petach Tikva
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shay Golan
Phone
+97239376554
Email
Shaygo1@gmail.com
12. IPD Sharing Statement
Learn more about this trial
The Ability of Adipose Flap Over the NVB to Improve Sexual and Urinary Function Following Radical Prostatectomy
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