Erectile Dysfunction, Prostate Cancer, Urinary Incontinence
Conditions
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.
Interventions
PROCEDURETechnical modification during radical prostatectomy
Covering the NVB with fat
Sponsors
Rabin Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Erectile function | Change from Baseline IIEF score at 12 months | IIEF erectile function score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Continence status | Change from Baseline King's score at 12 months | King's Health Questionnaire score |
Countries
Israel
Contacts
Primary ContactShay Golan, MD
Outcome results
None listed