NCT06179316

Brief 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 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2023

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

December 15, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 21, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

December 21, 2023

Status Verified

December 1, 2023

Enrollment Period

3 months

First QC Date

December 12, 2023

Last Update Submit

December 12, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • ııef-5 score

    The scale we use to evaluate patients' erection quality

    three months

Study Arms (3)

preoperative patients

Procedure: Robot Assisted Radical Prostatectomy

Patients in the 3rd postoperative month

Patients in the 6th month postoperatively

Interventions

Performing radical prostatectomy operation using robotic equipment while preserving bilateral nerve bundles

Also known as: Bilateral Nerve-Sparing Robot-Assisted Radical Prostatectomy Operation
preoperative patients

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

December 12, 2023

First Posted

December 21, 2023

Study Start

December 15, 2023

Primary Completion

March 1, 2024

Study Completion

July 1, 2024

Last Updated

December 21, 2023

Record last verified: 2023-12