Investigation of the Protective Effect of Alpha Lipoic Acid on Ischemic Reperfusion Damage in Ischemic Priapism in Rats

NCT07391709 | Completed

• 1 other identifier: 2024/2
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The condition known in medical terminology as 'Priapism' refers to the state of erection in the male sexual organ persisting partially or completely for more than 4 hours without sexual stimulation or orgasm. This 'prolonged and painful erection' is generally observed in young adults, although it can occur in all age groups, including the neonatal period. There are three main types: ischaemic (restricted blood flow), non-ischaemic (unrestricted blood flow), and recurrent 'prolonged and painful erection'. This disorder is believed to develop as a result of malfunctions in the mechanism that causes the male sexual organ to lose its erection (detumescence of the penis). Although the return of blood flow (reperfusion) to the tissue following the termination of 'long and painful erection' is necessary to preserve this structure that has been deprived of blood for a period of time, the return of blood flow itself initiates a mechanistic process that causes damage due to restricted blood flow and the return of blood flow to the tissue. Currently, there is no effective and safe medical treatment used to prevent tissue damage caused by ischaemia-reperfusion injury in the treatment of 'long and painful erection'. Currently, there is no effective and safe medical treatment used in the treatment of 'long and painful erection' to prevent tissue damage resulting from ischaemia-reperfusion injury. Alpha-lipoic acid is an antioxidant found in some foods and naturally produced in the body. In this study, a model of 'long and painful erection' will be created in a total of 18 rats divided into 6 groups, and the possible biochemical and histopathological protective effects of alpha-lipoic acid against this condition will be investigated.

Conditions

Priapism; Reperfusion Injury

Keywords

Priapism; Alpha Lipoic Acid; Ischemia-Reperfusion Injury; Antioxidant; Rat

Outcome Measures

Primary Outcomes (5)

• Change in serum total antioxidant status (TAS) measured by Erel spectrophotometric assay

  Serum total antioxidant status (TAS) will be measured using the Erel spectrophotometric assay.Unit of Measure mmol Trolox equivalent/L

  7 days after reperfusion

• Change in serum total oxidant status (TOS) measured by Erel spectrophotometric assay

  Serum total oxidant status (TOS) will be measured using the Erel spectrophotometric assay.Unit of Measure µmol H₂O₂ equivalent/L

  7 days after reperfusion

• Change in serum glutathione peroxidase (GPx) activity measured by spectrophotometric enzyme activity assay

  Serum glutathione peroxidase (GPx) activity will be measured using a spectrophotometric enzyme activity assay.Unit of Measure U/L

  7 days after reperfusion

• Change in serum malondialdehyde (MDA) concentration measured by ELISA

  Serum malondialdehyde (MDA) concentration will be measured using a commercial ELISA kit.Unit of Measure ng/mL

  7 days after reperfusion

• Change in serum ischemia-modified albumin (IMA) concentration measured by ELISA

  Serum ischemia-modified albumin (IMA) concentration will be measured using a commercial ELISA kit.Unit of Measure U/mL

  7 days after reperfusion

Secondary Outcomes (2)

• Change in serum tumor necrosis factor-alpha (TNF-α) concentration measured by ELISA

  7 days after reperfusion

• Change in penile tissue tumor necrosis factor-alpha (TNF-α) concentration measured by ELISA

  7 days after reperfusion

Other Outcomes (2)

• Change in GRP78 protein expression in penile tissue measured by immunohistochemistry

  7 days after reperfusion

• Change in CHOP protein expression in penile tissue measured by immunohistochemistry

  7 days after reperfusion

Study Arms (3)

Control group

NO INTERVENTION

Healthy rats with no induction of ischemic priapism or reperfusion. No pharmacological treatment was administered.

Ischemic priapism + reperfusion

EXPERIMENTAL

Ischemic priapism was induced by applying a tourniquet to the base of the penis for 4 hours, followed by reperfusion. No antioxidant or pharmacological treatment was given.

Procedure: Ischemic priapism + reperfusion

Ischemic priapism + reperfusion + ALA

EXPERIMENTAL

Ischemic priapism was induced by a 4-hour penile base tourniquet followed by reperfusion. Alpha-lipoic acid (ALA) was administered intraperitoneally at a dose of 100 mg/kg, 30 minutes before reperfusion.

Procedure: Ischemic priapism + reperfusion + ALA; Drug: Ischemic priapism + reperfusion + ALA

Interventions

Ischemic priapism + reperfusion PROCEDURE

Ischemic priapism was induced by applying a tourniquet to the base of the penis for 4 hours, followed by reperfusion.

Also known as: Penile ischemia-reperfusion injury model, Penile tourniquet-induced ischemic priapism, Experimental ischemic priapism model

Ischemic priapism + reperfusion

Ischemic priapism + reperfusion + ALA PROCEDURE

Ischemic priapism was induced by applying a tourniquet to the base of the penis for 4 hours, followed by reperfusion.

Also known as: Penile tourniquet-induced ischemic priapism, Experimental ischemic priapism model, Penile ischemia-reperfusion injury model

Ischemic priapism + reperfusion + ALA

Eligibility Criteria

• Age: 10 Weeks - 16 Weeks
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Adult male Sprague-Dawley rats weighing 350-400 g.

You may not qualify if:

• Animals with congenital anomalies, active infection, or systemic disease.
• Animals that died before completion of the experimental protocol.

Sponsors & Collaborators

• Trabzon Kanuni Education and Research Hospital: lead
• Karadeniz Technical University: collaborator

Study Sites (1)

Karadeniz Technical University Experimental Animal Research Center

Trabzon, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Priapism; Reperfusion Injury

Interventions

Reperfusion; Thioctic Acid

Condition Hierarchy (Ancestors)

Penile Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Perfusion; Investigative Techniques; Carboxylic Acids; Organic Chemicals; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Model Details: Randomised controlled group animal experiment

Study Record Dates

• First Submitted: January 1, 2026
• First Posted: February 6, 2026
• Study Start: February 10, 2024
• Primary Completion: July 10, 2024
• Study Completion: September 10, 2024
• Last Updated: February 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)