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
NCT number | NCT04577222 |
Other study ID # | 212-18 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 15, 2018 |
Est. completion date | July 15, 2022 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Israel | Rabin Medical Center | Petach Tikva |
Lead Sponsor | Collaborator |
---|---|
Rabin Medical Center |
Israel,
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 |
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