Clinical trial NCT03918993: Effects of Tadalafil on LMR and MHR in Patients With ED
Official title: Evaluation of the Effects of a Daily Dose of 5 mg of Tadalafil on Lymphocyte to Monocyte Ratio and Monocyte to High-Density Lipoprotein Ratio in Patients With Erectile Dysfunction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Erectile Dysfunction
Inflammation
Keywords: Erectile Dysfunction
lymphocyte to monocyte ratio
monocyte to HDL ratio
Lead sponsor: Samsun Liv Hospital
Sponsor class: OTHER
Collaborators: name: Ondokuz Mayıs University
First posted: 2019-04-18
Enrollment: 62
Sex: MALE
Minimum age (years): 39
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Between the ages of 39-65, thirty-one healthy men who were admitted to the internal medicine outpatient clinic for their annual follow-up were selected consecutively and the control group Thirty-one male patients with organic erectile dysfunction more than one year between 39 and 65 years of age which were treated with OAD 5 mg dose of tadalafil for eight weeks were selected as the treatment group

Brief summary: The aim of the study was to investigate whether daily 5 mg tadalafil over eight weeks affects to Lymphocyte/Monocyte ratio (LMR) and Monocyte/High-Density Lipoprotein ratio (MHR) in patients with erectile dysfunction (ED).

Thirty-one patients with organic ED and 31 healthy controls between July 2017 and November 2018 were included in this retrospective study. To avoid bias, the patients were randomly selected and the controls were also incorporated consecutively. The presence of ED was determined according to the International Erectile Function Index-5 (IIEF-5). The patients and the controls were evaluated in terms of IIEF-5, complete blood count, serum biochemistry, LMR, and MHR.

Detailed description: The medical records of the heterosexual men treated with the diagnosis of organic ED in the Urology department of a private hospital between July 2017 and October 2018 were evaluated retrospectively. The number of samples to be included in the study was determined by the help of the computer-assisted power analysis. Random sampling was performed from all cohorts of patients with ED. Thirty-one male patients between the ages of 39-65 with organic erectile dysfunction more than one year and treated with OAD 5 mg dose of tadalafil for eight weeks were selected as the treatment group (group T)The patients in group T have been assessed both before (T1) and after (T2) the treatment.

Between the ages of 39-65, thirty-one healthy men who were admitted to the internal medicine outpatient clinic for their annual follow-up were selected consecutively and the control group (group C) was formed. All subjects in the control group were sexually active men with regular monogamous heterosexual relationships during the last one year.

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Eligibility criteria: Inclusion Criteria:

* 39-65 years old men with ED
* 39-65 years old, haelthy men
* Patients that have received 5 mg tadalafil/day for 8 weeks
* Patients with informed consent forms
* Patients with no missing variables

Exclusion Criteria:

* Patients with systemic autoimmune and inflammatory disease,
* congestive heart failure,
* chronic renal failure, and chronic hepatobiliary disease,
* chronic lung disease, and thyroid dysfunction,
* patients with acute infection,
* patients with neurological deficits,
* metabolic syndrome and malignancy
* Patients with a history of prostate, penile or pelvic surgery or radiotherapy,,
* patients receiving anticoagulant, beta-blocker, antidepressants and antipsychotics, hormonal therapy,
* patients with alcohol and smoking

Primary outcomes:
measure: Lymphocyte to Monocyte Ratio
timeFrame: up to 8 weeks
measure: monocyte to HDL ratio
timeFrame: up to 8 weeks
measure: The International Index of Erectile Function (IIEF-5) Questionnaire
timeFrame: up to 8 weeks
measure: monocyte count
timeFrame: up to 8 weeks
measure: lymphocyte count
timeFrame: up to 8 weeks
measure: HDL cholesterol
timeFrame: up to 8 weeks
measure: Testosteron
timeFrame: up to 8 weeks
measure: fasting glucose
timeFrame: at the 1st day
Secondary outcomes:
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Samsun Liv Hospital
Study officials:
affiliation: Ondokuz Mayıs University
name: Yakup Bostancı, MD
role: STUDY_CHAIR
References:
citation: Gupta BP, Murad MH, Clifton MM, Prokop L, Nehra A, Kopecky SL. The effect of lifestyle modification and cardiovascular risk factor reduction on erectile dysfunction: a systematic review and meta-analysis. Arch Intern Med. 2011 Nov 14;171(20):1797-803. doi: 10.1001/archinternmed.2011.440. Epub 2011 Sep 12.
citation: Kadihasanoglu M, Karabay E, Yucetas U, Erkan E, Ozbek E. Relation between Monocyte to High-Density Lipoprotein Cholesterol Ratio and Presence and Severity of Erectile Dysfunction. Aktuelle Urol. 2018 Jun;49(3):256-261. doi: 10.1055/s-0042-123163. Epub 2017 Nov 16.
citation: Cimen S, Dursun M, Sulukaya M, Besiroglu H. Could the monocyte/HDL cholesterol ratio be an early marker of erectile dysfunction? Aging Male. 2020 Dec;23(5):694-699. doi: 10.1080/13685538.2019.1574735. Epub 2019 Feb 19.