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

NCT06163157 | Completed

• 1 other identifier: ED-CTM
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Erectile Dysfunction

Keywords

Erectile dysfunction; Connective tissue massage

Outcome Measures

Primary Outcomes (2)

• The International Index of Erectile Function (IIEF-5)

  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).

  Change from baseline at 4 weeks

• Composite Autonomic Symptom Score (COMPASS 31)

  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.

  Change from baseline at 4 weeks

Secondary Outcomes (2)

• 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 Arms (2)

Control roup

NO INTERVENTION

The control group will receive standard treatment (lifestyle recommendations).

CTM group

EXPERIMENTAL

In addition to the standard treatment, connective tissue massage will be applied to the CTM group.

Other: Connective tissue massage(CTM)

Interventions

Connective tissue massage(CTM) OTHER

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

CTM group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bitlis Eren University: lead

Study Sites (1)

Bitlis Eren University

Bitlis, 13000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: December 8, 2023
• Study Start: December 21, 2023
• Primary Completion: December 21, 2024
• Study Completion: December 21, 2024
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)