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

NCT04577222 | Unknown

• 1 other identifier: 212-18
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Erectile Dysfunction; Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• Erectile function

  IIEF erectile function score

  Change from Baseline IIEF score at 12 months

Secondary Outcomes (1)

• Continence status

  Change from Baseline King's score at 12 months

Study Arms (2)

Adipose Flap

EXPERIMENTAL

Covering neurovascular bundle with fat

Procedure: Technical modification during radical prostatectomy

Control

NO INTERVENTION

No adipose flap

Interventions

Technical modification during radical prostatectomy PROCEDURE

Covering the NVB with fat

Adipose Flap

Eligibility Criteria

• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Patients who did not undergo NVB preservation or technical inability to create flap

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Rabin Medical Center

Petah Tikva, Israel

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Erectile Dysfunction; Urinary Incontinence

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Mental Disorders; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Shay Golan, MD

CONTACT

+972507447573; Shaygo1@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: July 30, 2018
• First Posted: October 6, 2020
• Study Start: April 15, 2018
• Primary Completion: April 15, 2022
• Study Completion: July 15, 2022
• Last Updated: October 6, 2020

Record last verified: 2020-10

Locations

IL (1)