CClinicalTrials.gg
CompletedNCT06163157Updated Dec 27, 2024

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

An interventional study of Connective tissue massage(CTM) in Erectile Dysfunction, sponsored by Bitlis Eren University. Completed at 1 site in Turkey. Open to male participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-12-27.

Sponsored by Bitlis Eren University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
20 Years to 65 Years
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Erectile Dysfunction

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Keywords

  • Erectile dysfunction
  • Connective tissue massage
03

In context

Erectile Dysfunction

683 studies on the registry are indexed under Erectile Dysfunction; 116 are open to participants now.

This study's enrollment of 30 is below the median of 72 across 541 interventional studies indexed under Erectile Dysfunction.

Browse Erectile Dysfunction studies →

Lead sponsor

Bitlis Eren University is the lead sponsor of 48 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
Male
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • No intervention
    Control roup

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

  • Experimental
    CTM group

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

    Other: Connective tissue massage(CTM)

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.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Change from baseline at 4 weeks

  2. 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.

    Time frame: Change from baseline at 4 weeks

Secondary outcomes

  1. 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.

    Time frame: Change from baseline at 4 weeks

  2. 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.

    Time frame: Change from baseline at 4 weeks

07

Study locations

1 site
  • Bitlis Eren University
    Bitlis, 13000, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06163157
Lead sponsor
Bitlis Eren University
Responsible party
Mesut Arslan (Assistant Professor, Bitlis Eren University) — Principal investigator
First posted
Dec 8, 2023
Start date
Dec 21, 2023
Primary completion
Dec 21, 2024
Completion
Dec 21, 2024
Last update
Dec 27, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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