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Clinical Trials/NCT06163157
NCT06163157
Completed
Not Applicable

Investigation of the Effectiveness of Connective Tissue Massage in Individuals With Erectile Dysfunction Symptoms

Bitlis Eren University1 site in 1 country30 target enrollmentDecember 21, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Erectile Dysfunction
Sponsor
Bitlis Eren University
Enrollment
30
Locations
1
Primary Endpoint
The International Index of Erectile Function (IIEF-5)
Status
Completed
Last Updated
last year

Overview

Brief Summary

In this study, it is planned to investigate the effect of connective tissue massage on symptom severity, autonomic functions, psychological state and quality of life in individuals with erectile dysfunction symptoms.

Detailed Description

The most common sexual dysfunctions in men include erectile dysfunction and premature ejaculation. Erectile dysfunction (ED) is defined as the inability to achieve and maintain the penile erection necessary for sexual intercourse for at least 6 months.The prevalence of ED generally varies between 37.2%-48.6%. There are various treatment methods used in individuals with ED symptoms. While urologists use oral phosphodiesterase-5 inhibitor drugs (such as sildenafil and vardenafil) as the first step, intracavernosal papaverine or alprostadil injections and vacuum devices may be preferred afterwards. When these treatments are inadequate, penile prostheses can be used. In addition, various physiotherapy techniques such as pelvic floor muscle training, electrical stimulation, massage and aerobic exercises are also recommended for these individuals.

Registry
clinicaltrials.gov
Start Date
December 21, 2023
End Date
December 21, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Sponsor
Bitlis Eren University
Responsible Party
Principal Investigator
Principal Investigator

Mesut Arslan

Assistant Professor

Bitlis Eren University

Eligibility Criteria

Inclusion Criteria

  • Male subjects aged 20-65 years with ED complaints for at least 6 months will be included in the study. In addition, sexually active individuals will be included in the study

Exclusion Criteria

  • Patients with diabetes and renal diseases, uncontrolled hypertension, priapism, pacemaker users, history of psychiatric or psychological illness, skin lesions/ulcer in the penis or lumbosacral region, and patients who are unable to cooperate will be excluded.

Outcomes

Primary Outcomes

The International Index of Erectile Function (IIEF-5)

Time Frame: Change from baseline at 4 weeks

İt is a 5-question questionnaire used to assess erectile dysfunction. Patients' answers to each question are scored between 1 and 5. A total score above 21 indicates normal erectile function, while a score of 21 and below indicates ED. According to the total score obtained from the scale, ED is divided into 4 categories. Severe (1-7), moderate (8-11), moderate to mild (12-16), mild (17-21) and no ED (22-25).

Composite Autonomic Symptom Score (COMPASS 31)

Time Frame: Change from baseline at 4 weeks

İt is a 31-question questionnaire that assesses autonomic symptoms in 6 different areas: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder function and pupillomotor. Survey score varies between 0-100 points. A high score on the questionnaire indicates the presence and severity of autonomic dysfunction.

Secondary Outcomes

  • Depression Anxiety Stress Scale (DASS-21)(Change from baseline at 4 weeks)
  • Quality of Life Questionnaire (SF-36)(Change from baseline at 4 weeks)

Study Sites (1)

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