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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Ability of Adipose Flap Over the NVB to Improve Sexual and Urinary Function Following Radical Prostatectomy; a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04577222
- Acronym / sponsor ID
- 212-18
- Conditions
- Prostate Cancer, Erectile Dysfunction, Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- 15 Apr 2018 (actual)
- Primary completion
- 15 Apr 2022 (estimated)
- Study completion
- 15 Jul 2022 (estimated)
- First posted
- 6 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adipose Flap | Experimental | Procedure: Technical modification during radical prostatectomyCovering neurovascular bundle with fat |
| Control | No intervention | –No adipose flap |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (1 listed)
- Patients who did not undergo NVB preservation or technical inability to create flap
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Technical modification during radical prostatectomyCovering the NVB with fat | Procedure or surgery | Adipose Flap |
Primary outcome
Erectile function
Time frame: Change from Baseline IIEF score at 12 months
IIEF erectile function score
1 secondary outcome
Continence status
Time frame: Change from Baseline King's score at 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2020.
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shay Golan, MD (+972507447573, Shaygo1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Erectile function (time frame: Change from Baseline IIEF score at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2020.