The Relationship Between Bone Pelvis Measurements and Erectile Function in Patients Who Had Nerve-Sparing Robot-Assisted Radical Prostatectomy Operation

December 12, 2023 updated by: Ali Kaan Yildiz, Ankara Training and Research Hospital
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

120

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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

Description

Inclusion Criteria:

  • Having bilateral nerve-sparing robot-assisted radical prostatectomy operation
  • Having a regular sexual life

Exclusion Criteria:

  • Having received neoadjuvant therapy
  • Having a history of radiotherapy to the pelvic area
  • The need to receive postoperative hormono-radiotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
preoperative patients
Procedure: Robot Assisted Radical Prostatectomy
Performing radical prostatectomy operation using robotic equipment while preserving bilateral nerve bundles
Other Names:
  • Bilateral Nerve-Sparing Robot-Assisted Radical Prostatectomy Operation
Patients in the 3rd postoperative month
Patients in the 6th month postoperatively

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ııef-5 score
Time Frame: three months
The scale we use to evaluate patients' erection quality
three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 15, 2023

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

December 12, 2023

First Submitted That Met QC Criteria

December 12, 2023

First Posted (Estimated)

December 21, 2023

Study Record Updates

Last Update Posted (Estimated)

December 21, 2023

Last Update Submitted That Met QC Criteria

December 12, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AŞH.AKYILDIZ.007

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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