Vascular Effects of Penil revascularızatıon

NCT06350019 | Completed

• 1 other identifier: 26379996/91
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

Brief Summary

Purpose: The aim of this study is to measure the effects of penile revascularization surgery performed in vascular origin erectile dysfunction (ED) on penile vascular hemodynamic and to determine the importance of vascular parameters in postoperative patient follow-up. Methods: A total of 35 participants who underwent penile revascularization surgery due to vascular ED were included in this study. In the preoperative period and at the 3rd postoperative month, penile color doppler ultrasonography (PCDU) was performed to evaluate cavernosal arteries, dorsal arteries, deep dorsal vein and inferior epigastric artery (IEA) separately. During this evaluation, peak systolic velocity (PSV), end diastolic velocity (EDV), and resistive index (RI) were measured. The International Index of Erectile Function questionnaire (IIEF) was applied to all patients in the preoperative period and at the 3rd postoperative month. The relationship between changes in (IIEF) questionnaire score and penile vascular hemodynamic changes in the postoperative period was evaluated.

Conditions

Erectile Dysfunction; Erectile Dysfunction Due to Arterial Disease; Erectile Dysfunction Due to Venous Disorder

Keywords

Erectile dysfunction; Penile revascularization; Penile color doppler ultrasonography; Resistive index

Outcome Measures

Primary Outcomes (1)

• The importance of resistive index in evaluating the postoperative success of penile revascularization

  Penile revascularization was performed in 35 cases with the diagnosis of erectile dysfunction of vascular origin. Both preoperative and postoperative international index of erectile function questionaire (IIEF) and penile color Doppler ultrasound (PCDU) were performed in all cases, and IIEF 5/15 scores and resistive index (RI) were calculated. After the operation, computerized tomography angiography (CTA) was performed to confirm anastomotic patency. The correlation between RI and IIEF was evaluated in the postoperative period. RI = 0.85 was accepted as the limit value to evaluate postoperative success. Cases with RI\>0.85 were considered successful and cases with RI\<0.85 were considered unsuccessful.

  3 months (Postoperative third months)

Study Arms (1)

Cases with erectile dysfunction of vascular origin

EXPERIMENTAL

Penile revascularization surgery was performed in cases with erectile dysfunction of vascular origin. Penile color Doppler ultrasonography, corpus cavernosum electromyography and cavernosometry tests were performed on all cases in the preoperative period and at the 3rd postoperative month. Penile computed tomography angiography was performed at the 3rd postoperative month.

Procedure: Penile revascularızation

Interventions

Penile revascularızation PROCEDURE

The importance of resistive index in the preoperative evaluation of vascular-induced erectile dysfunction, predicting the success of penile revascularization surgery, and postoperative patient management was investigated.

Cases with erectile dysfunction of vascular origin

Eligibility Criteria

• Age: 23 Years - 69 Years
• Gender Eligibility Details: All cases included in the study were male individuals.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cases that do not benefit from oral phosphodiesterase 5 inhibitor or intracavernosal injection treatment
• Cases with PSV\<25 cm/s in PCDU
• Cases with PSV\>25 cm/s, EDV\>5 cm/s and RI\<0.85 in PCDU
• Patients with relaxation degree above 50% in CC-EMG
• Cases with venous leakage in cavernosometry

You may not qualify if:

• hypogonadism (primer or secondary),
• Cases benefiting from phosphodiesterase 5 inhibitors
• Cases benefiting from intracavernous alprostadil
• Those with a history of urogenital, rectal and similar operations
• Those with Peyronie's disease
• Cases of neurogenic and psychogenic origin

Sponsors & Collaborators

• Ankara Yildirim Beyazıt University: lead

Related Publications (1)

• Akdemir F, Kayigil O. Vascular hemodynamic effects of penile revascularization surgery and the role of resistive index in follow-up. Basic Clin Androl. 2024 Dec 20;34(1):28. doi: 10.1186/s12610-024-00243-0.

  PMID: 39701967 DERIVED

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Fatih AKDEMİR

  Ankara Yildirim Beyazıt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof.

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 5, 2024
• Study Start: January 1, 2013
• Primary Completion: August 15, 2014
• Study Completion: December 25, 2014
• Last Updated: April 5, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share