Prostate CancerNCT04577222
The Ability of Adipose Flap Over the NVB to Improve Sexual and Urinary Function Following Radical Prostatectomy
A study testing Technical modification during radical prostatectomy in people with Prostate Cancer and Erectile Dysfunction, run by Rabin Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer, Erectile Dysfunction, Urinary Incontinence
- What is being tested?
- Technical modification during radical prostatectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- 15 Apr 2018to 15 Jul 2022
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male aged 18 years and older.
- Patients diagnosed with prostate cancer.
- Patients should be potent (IIEF erectile function domain score of 26 and above) and have a sexual partner.
- Patients scheduled for Radical Prostatectomy with NVB preservation (at least unilateral).
Who cannot join
- Patients who did not undergo NVB preservation or technical inability to create flap
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Rabin Medical Center
Petah Tikva
Shay Golan, +97239376554, Shaygo1@gmail.com
About this study
Official title: The Ability of Adipose Flap Over the NVB to Improve Sexual and Urinary Function Following Radical Prostatectomy; a Randomized Control Trial
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.
- Conditions
- Prostate Cancer, Erectile Dysfunction, Urinary Incontinence
- Being tested
- Technical modification during radical prostatectomy
- Medical subject headings
- Prostatic Neoplasms, Erectile Dysfunction, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technical modification during radical prostatectomyProcedure or surgery
Covering the NVB with fat
| Study group | Role | What they receive |
|---|---|---|
| Adipose Flap | Experimental | Covering neurovascular bundle with fat Receives: Procedure: Technical modification during radical prostatectomy |
| Control | No intervention | No adipose flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Erectile function
IIEF erectile function score
Measured: Change from Baseline IIEF score at 12 months
Secondary outcomes (1)
Continence status
King's Health Questionnaire score
Measured: Change from Baseline King's score at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2020
- Study start15 Apr 2018
- Primary completion15 Apr 2022 (estimated)
- Study completion15 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, golan shay, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04577222
- Sponsor's protocol ID
- 212-18
- Status last verified
- Oct 2020
- First submitted
- 30 Jul 2018
- Last updated
- 6 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No