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

Not Applicable

• Conditions: Urinary Incontinence; Prostate Cancer; Erectile Dysfunction
• Interventions: Procedure: Technical modification during radical prostatectomy

• Registration Number: NCT04577222
• Lead Sponsor: Rabin Medical Center

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 available

Study Timeline

• Study Start: 2018-04-15
• Study First Submitted: 2018-07-30
• Status Verified: 2020-10
• Study First Submitted QC: 2020-10-05
• Last Update Submitted: 2020-10-05
• Study First Posted: 2020-10-06
• Last Update Posted: 2020-10-06
• Primary Completion: 2022-04-15
• Study Completion: 2022-07-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adipose Flap	Technical modification during radical prostatectomy	Covering neurovascular bundle with fat

Primary Outcome Measures

Name	Time	Method
Erectile function	Change from Baseline IIEF score at 12 months	IIEF erectile function score

Secondary Outcome Measures

Name	Time	Method
Continence status	Change from Baseline King's score at 12 months	King's Health Questionnaire score

Trial Locations

Locations (1)

Rabin Medical Center; 🇮🇱 Petach Tikva, Israel