Erectile DysfunctionNCT06163157
Investigation of the Effectiveness of Connective Tissue Massage in Individuals With Erectile Dysfunction Symptoms
A study testing Connective tissue massage(CTM) in people with Erectile Dysfunction, run by Bitlis Eren University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 20 to 65 years, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Connective tissue massage(CTM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Dec 2023to 21 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Erectile Dysfunction
- Being tested
- Connective tissue massage(CTM)
- Keywords
- Erectile dysfunction, Connective tissue massage
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Connective tissue massage(CTM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Change from baseline at 4 weeks
Secondary outcomes (2)
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.
Measured: Change from baseline at 4 weeks
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.
Measured: Change from baseline at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start21 Dec 2023
- Primary completion21 Dec 2024
- Study completion21 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bitlis Eren University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mesut Arslan, Bitlis Eren University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06163157
- Sponsor's protocol ID
- ED-CTM
- Status last verified
- Dec 2024
- First submitted
- 20 Nov 2023
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of Connective Tissue Massage in Individuals With Erectile Dysfunction Symptoms
- ClinicalTrials.gov ID
- NCT06163157
- Acronym / sponsor ID
- ED-CTM
- Conditions
- Erectile Dysfunction
- Keywords
- Erectile dysfunction, Connective tissue massage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bitlis Eren UniversityUniversity, hospital or other
- Study start
- 21 Dec 2023 (actual)
- Primary completion
- 21 Dec 2024 (actual)
- Study completion
- 21 Dec 2024 (actual)
- First posted
- 8 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control roup | No intervention | –The control group will receive standard treatment (lifestyle recommendations). |
| CTM group | Experimental | Other: Connective tissue massage(CTM)In addition to the standard treatment, connective tissue massage will be applied to the CTM group. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | CTM group |
Primary outcome
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.
2 secondary outcomes
Depression Anxiety Stress Scale (DASS-21)
Time frame: Change from baseline at 4 weeks
Quality of Life Questionnaire (SF-36)
Time frame: Change from baseline at 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Connective tissue massage(CTM) in people with Erectile Dysfunction, run by Bitlis Eren University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The International Index of Erectile Function (IIEF-5) (time frame: Change from baseline at 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.