Erectile DysfunctionNCT06179316
The Relationship Between Bone Pelvis Measurements and Erectile Function in Patients Who Had Nerve-Sparing Robot-Assisted Radical Prostatectomy Operation
An observational study of Erectile Dysfunction, run by Ankara Training and Research Hospital.
Trial summary
In order to evaluate the relationship between bone pelvis measurements and erectile function in patients who underwent nerve-sparing robot-assisted radical prostatectomy, bone pelvis measurements will be measured from MRI images of the patients before the operation and their erection quality will be evaluated with the… Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Robot Assisted Radical Prostatectomy
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2023to 1 Jul 2024
- Phase
- Observational
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
Study population: Preoperative Prostate MRI imaging was performed, "Bilateral Nerve Saving Robot Assisted Radical Prostatectomy Operation" was performed, and a regular sexual life was performed; Male patients who have not received neoadjuvant therapy, have no history of radiotherapy to the pelvic region, and do not need postoperative hormono-radiotherapy
Who may be able to join
- Having bilateral nerve-sparing robot-assisted radical prostatectomy operation
- Having a regular sexual life
Who cannot join
- Having received neoadjuvant therapy
- Having a history of radiotherapy to the pelvic area
- The need to receive postoperative hormono-radiotherapy
About this study
In order to evaluate the relationship between bone pelvis measurements and erectile function in patients who underwent nerve-sparing robot-assisted radical prostatectomy, bone pelvis measurements will be measured from MRI images of the patients before the operation and their erection quality will be evaluated with the IIEF-5 form. The erection quality of the same patients will be evaluated with the IIEF-5 form in the 3rd and 6th months after the operation. And it will be evaluated whether there is a relationship between the erection quality of the patients before and after the operation and their bone pelvis measurements.
- Conditions
- Erectile Dysfunction
- Being tested
- Robot Assisted Radical Prostatectomy
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot Assisted Radical ProstatectomyProcedure or surgery
Also called Bilateral Nerve-Sparing Robot-Assisted Radical Prostatectomy Operation
Performing radical prostatectomy operation using robotic equipment while preserving bilateral nerve bundles
| Study group | Role | What they receive |
|---|---|---|
| preoperative patients | Not described Receives: Procedure: Robot Assisted Radical Prostatectomy | |
| Patients in the 3rd postoperative month | Not described | |
| Patients in the 6th month postoperatively | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
ııef-5 score
The scale we use to evaluate patients' erection quality
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2023
- Study start15 Dec 2023 (estimated)
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Kaan Yildiz, Ankara Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06179316
- Sponsor's protocol ID
- AŞH.AKYILDIZ.007
- Status last verified
- Dec 2023
- First submitted
- 12 Dec 2023
- Last updated
- 21 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No