Impact of Glycemic Control on Penile Duplex Results

NCT06220968 | Not Yet Recruiting

• 1 other identifier: Penile duplex
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study aimed at evaluating the impact of glycemic control on the erectile function , penile Doppler, and cavernosal blood NO and glutathione levels among a group of diabetic patients with erectile dysfunction.

Conditions

Erectile Dysfunction With Diabetes Mellitus

Outcome Measures

Primary Outcomes (3)

• Penile doppler ultrasound

  penile Doppler and measuring cavernosal blood nitric oxide and glutathione levels to compare penile doppler ultrasound brfore and after glycemic control .

  Baseline

• Cavernosal blood nitric oxide

  Comparing cavernosal blood nitric oxide brfore and after glycemic control

  Baseline

• Cavernosal blood glutathione level

  Comparing cavernosal blood glutathione levels brfore and after glycemic control

  Baseline

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: male
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

This prospective observational study will include 100 patients attending our andrology outpatient clinic at Assuit University Hospitals, Egypt, complaining of uncontrolled diabetes mellitus (HBA1C more than 8) and secondary ED for more than 6 months, from October 2023 and over a year. Patients will be included in the study after obtaining a written informed consent and ethical committee approval.

You may qualify if:

• Married Male patients diagnosed with erectile dysfunction.
• Age from 30 to 55 years.
• Documented history of DM.
• Regular sexual life with cooperative wife.

You may not qualify if:

• Patients with congenital anomalies like hypospadius and curvature.
• History of pelvic or spine surgery.
• Single patient.
• Thyroid disorders.
• Other sexual disorders.
• Primary ED.
• History of Peyronie's disease or priapism.

Sponsors & Collaborators

• Assiut University: lead

Study Officials

• Ahmed Ab Elshibany

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mahmoud Ab Khalaf

CONTACT

01220570189; MahmoudFakir152997@gmail.com

Mahmoud Al Khodiry

CONTACT

01151962094; MahmoudFakir152997@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 24, 2024
• Study Start: January 1, 2025
• Primary Completion: January 1, 2025
• Study Completion: March 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09