The Ability of Adipose Flap Over the NVB to Improve Sexua... | NCT04577222

Studies
The Ability of Adipose Flap Over the NVB to Improve Sexual and Urinary Function Following Radical Prostatectomy

NCT04577222

Sponsor

Rabin Medical Center

Status

Unknown status

Last Update Posted

Oct 6, 2020Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Prostate Cancer
Erectile Dysfunction
Urinary Incontinence

Interventions

Technical modification during radical prostatectomy

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 15, 2018Actual

Primary Completion Date

Apr 15, 2022Estimated

Completion Date

Jul 15, 2022Estimated

First Submitted Date

Jul 30, 2018

First Submission Date that Met QC Criteria

Oct 5, 2020

First Posted Date

Oct 6, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 5, 2020

Last Update Posted Date

Oct 6, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Adipose Flap	Experimental	Covering neurovascular bundle with fat	Procedure: Technical modification during radical prostatectomy
Control	No Intervention	No adipose flap

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Technical modification during radical prostatectomy	Procedure	Covering the NVB with fat	Adipose Flap

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Erectile function	IIEF erectile function score	Change from Baseline IIEF score at 12 months

Secondary Outcomes

Measure	Description	Time Frame
Continence status	King's Health Questionnaire score	Change from Baseline King's score at 12 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Shay Golan, MD	Contact	+972507447573		Shaygo1@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rabin Medical Center	Recruiting	Petah Tikva			Israel

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms
D007172	Erectile Dysfunction
D014549	Urinary Incontinence

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided