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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06163157
Enrollment
30
Registered
2023-12-08
Start date
2023-12-21
Completion date
2024-12-21
Last updated
2024-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile Dysfunction

Keywords

Erectile dysfunction, Connective tissue massage

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.

Interventions

OTHERConnective tissue massage(CTM)

CTM will be applied by a trained physiotherapist for 3 days/week for 4 weeks. Application time will be approximately 15-20 minutes.

Sponsors

Bitlis Eren University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
20 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The International Index of Erectile Function (IIEF-5)Change from baseline at 4 weeksİt 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)Change from baseline at 4 weeksİt 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

MeasureTime frameDescription
Depression Anxiety Stress Scale (DASS-21)Change from baseline at 4 weeksIt evaluates the condition of the individual in the last week. It is a 21-question questionnaire consisting of 3 subscales: depression, anxiety and stress. Survey score varies between 0-63 points. A high score on the questionnaire indicates the presence and severity of depression, anxiety and stress.
Quality of Life Questionnaire (SF-36)Change from baseline at 4 weeksIt is a 36-question questionnaire consisting of 8 subscales including physical function, physical role, emotional role, pain, vitality, general health and mental health. Survey score varies between 0-100 points. A high score obtained from the questionnaire indicates that the individual has a good quality of life.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026