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

Rabin Medical Center60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Prostate Cancer Erectile Dysfunction Urinary Incontinence

Interventions

Eligibility

Sex: MALE

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male aged 18 years and older. 2. Patients diagnosed with prostate cancer. 3. Patients should be potent (IIEF erectile function domain score of 26 and above) and have a sexual partner. 4. 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

Outcomes

Primary Outcomes

Erectile function

IIEF erectile function score

Time frame: Change from Baseline IIEF score at 12 months

Secondary Outcomes

Continence status

King's Health Questionnaire score

Time frame: Change from Baseline King's score at 12 months