Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-29 @ 2:28 AM
Study NCT ID:
NCT06163157
Status:
COMPLETED
Last Update Posted:
2024-12-27
First Post:
2023-11-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of the Effectiveness of Connective Tissue Massage in Individuals With Erectile Dysfunction Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007172', 'term': 'Erectile Dysfunction'}], 'ancestors': [{'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-12-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-22', 'studyFirstSubmitDate': '2023-11-20', 'studyFirstSubmitQcDate': '2023-11-30', 'lastUpdatePostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The International Index of Erectile Function (IIEF-5)', 'timeFrame': 'Change from baseline at 4 weeks', 'description': "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)."}, {'measure': 'Composite Autonomic Symptom Score (COMPASS 31)', 'timeFrame': 'Change from baseline at 4 weeks', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Depression Anxiety Stress Scale (DASS-21)', 'timeFrame': 'Change from baseline at 4 weeks', 'description': '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.'}, {'measure': 'Quality of Life Questionnaire (SF-36)', 'timeFrame': 'Change from baseline at 4 weeks', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Erectile dysfunction', 'Connective tissue massage'], 'conditions': ['Erectile Dysfunction']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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%.\n\nThere 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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n\nExclusion Criteria:\n\n* 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.'}, 'identificationModule': {'nctId': 'NCT06163157', 'briefTitle': 'Investigation of the Effectiveness of Connective Tissue Massage in Individuals With Erectile Dysfunction Symptoms', 'organization': {'class': 'OTHER', 'fullName': 'Bitlis Eren University'}, 'officialTitle': 'Investigation of the Effectiveness of Connective Tissue Massage in Individuals With Erectile Dysfunction Symptoms', 'orgStudyIdInfo': {'id': 'ED-CTM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control roup', 'description': 'The control group will receive standard treatment (lifestyle recommendations).'}, {'type': 'EXPERIMENTAL', 'label': 'CTM group', 'description': 'In addition to the standard treatment, connective tissue massage will be applied to the CTM group.', 'interventionNames': ['Other: Connective tissue massage(CTM)']}], 'interventions': [{'name': 'Connective tissue massage(CTM)', 'type': 'OTHER', 'description': 'CTM will be applied by a trained physiotherapist for 3 days/week for 4 weeks. Application time will be approximately 15-20 minutes.', 'armGroupLabels': ['CTM group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13000', 'city': 'Bitlis', 'country': 'Turkey (Türkiye)', 'facility': 'Bitlis Eren University', 'geoPoint': {'lat': 38.40115, 'lon': 42.10784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bitlis Eren University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Mesut Arslan', 'investigatorAffiliation': 'Bitlis Eren University'}}}}