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

Prostate Cancer Clinical Trial

Official title:

The Ability of Adipose Flap Over the NVB to Improve Sexual and Urinary Function Following Radical Prostatectomy; a Randomized Control Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04577222
• Other study ID #: 212-18
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2018
• Est. completion date: July 15, 2022

Study information

• Verified date: October 2020
• Source: Rabin Medical Center
• Contact: Shay Golan, MD
• Phone: +972507447573
• Email: Shaygo1[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 15, 2022
• Est. primary completion date: April 15, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Erectile Dysfunction
• Prostate Cancer
• Urinary Incontinence

Intervention

Procedure:
• Technical modification during radical prostatectomy
Covering the NVB with fat

Locations

Country	Name	City	State
Israel	Rabin Medical Center	Petach Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Erectile function	IIEF erectile function score	Change from Baseline IIEF score at 12 months
Secondary	Continence status	King's Health Questionnaire score	Change from Baseline King's score at 12 months