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

Erectile Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06163157
• Other study ID #: ED-CTM
• Status: Recruiting
• Phase: N/A
• Start date: December 21, 2023
• Est. completion date: December 21, 2024

Study information

• Verified date: March 2024
• Source: Bitlis Eren University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 21, 2024
• Est. primary completion date: December 21, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Other:
• Connective 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.

Locations

Country	Name	City	State
Turkey	Bitlis Eren University	Bitlis

Sponsors (1)

Lead Sponsor	Collaborator
Bitlis Eren University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The International Index of Erectile Function (IIEF-5)	It 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).	Change from baseline at 4 weeks
Primary	Premature Ejaculation Diagnostic Tool (PEDT)	It is a 5-question questionnaire that evaluates control, frequency, minimum stimulation, distress and interpersonal difficulty parameters related to premature ejaculation (PE). A total score of 8 indicates no PE, 9-10 indicates possible PE, and a score equal to or higher than 11 indicates PE.	Change from baseline at 4 weeks
Primary	Composite Autonomic Symptom Score (COMPASS 31)	It 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.	Change from baseline at 4 weeks
Secondary	Depression Anxiety Stress Scale (DASS-21)	It 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.	Change from baseline at 4 weeks
Secondary	Quality of Life Questionnaire (SF-36)	It 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.	Change from baseline at 4 weeks