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

Clalit Health Services

Status: Unknown

Conditions: Erectile Dysfunction; Prostate Cancer; Urinary Incontinence

Treatments: Procedure: Technical modification during radical prostatectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04577222

212-18

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: Male

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Adipose Flap

Experimental group

Description:

Covering neurovascular bundle with fat

Treatment:

Procedure: Technical modification during radical prostatectomy

Control

No Intervention group

Description:

No adipose flap