Ignite Creation Date:
2025-12-24 @ 3:07 PM
Ignite Modification Date:
2026-02-04 @ 12:52 AM
Study NCT ID:
NCT02984592
Status:
COMPLETED
Last Update Posted:
2017-02-03
First Post:
2016-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Exercise on Premature Ejaculation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D061686', 'term': 'Premature Ejaculation'}], 'ancestors': [{'id': 'D000097910', 'term': 'Ejaculatory Dysfunction'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'targetDuration': '1 Month', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2017-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-02', 'studyFirstSubmitDate': '2016-12-01', 'studyFirstSubmitQcDate': '2016-12-06', 'lastUpdatePostDateStruct': {'date': '2017-02-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-12-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'intravaginal ejaculatory latency time', 'timeFrame': '1 month', 'description': 'IELT value (second) according to the duration determined by the sexual partner with stopwatch method'}], 'secondaryOutcomes': [{'measure': 'Premature ejaculation diagnostic tool score', 'timeFrame': '1 month', 'description': 'Premature Ejaculation Diagnostic Tool (PEDT) includes five items; control, frequency, minimal stimulation, distress, and interpersonal difficulty. In this classification tool, score 8 indicates no premature ejaculation, scores 9 and 10 indicate possible premature ejaculation, and scores equal or higher than 11 indicates premature ejaculation.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['premature ejaculation', 'intravaginal ejaculatory latency time', 'premature ejaculation diagnostic tools'], 'conditions': ['Premature Ejaculation']}, 'referencesModule': {'references': [{'pmid': '22320846', 'type': 'RESULT', 'citation': 'Pastore AL, Palleschi G, Leto A, Pacini L, Iori F, Leonardo C, Carbone A. A prospective randomized study to compare pelvic floor rehabilitation and dapoxetine for treatment of lifelong premature ejaculation. Int J Androl. 2012 Aug;35(4):528-33. doi: 10.1111/j.1365-2605.2011.01243.x. Epub 2012 Feb 9.'}, {'pmid': '24883105', 'type': 'RESULT', 'citation': 'Pastore AL, Palleschi G, Fuschi A, Maggioni C, Rago R, Zucchi A, Costantini E, Carbone A. Pelvic floor muscle rehabilitation for patients with lifelong premature ejaculation: a novel therapeutic approach. Ther Adv Urol. 2014 Jun;6(3):83-8. doi: 10.1177/1756287214523329.'}]}, 'descriptionModule': {'briefSummary': 'Premature ejaculation (PE) is one of the prevalent disorders in men; its leading sequel such as lack of self-confidence, anxiety, depression and unsatisfactory intercourse in men and their partners. The current study was aimed to evaluate the relationship between ejaculation and physical activity.', 'detailedDescription': 'Premature ejaculation (PE) is the most frequent sexual dysfunction in males, and its prevalence has been reported as 21-33%. Currently, there are no universal criteria for the diagnosis, or treatment strategies or approaches for PE. Lack of observational studies directed to PE makes comprehension of this sexual dysfunction difficult. The common point for definition of PE is a short duration between penetration and ejaculation, little or no control on voluntary control of ejaculation, and annoying character and negative effect of this condition on the individual. There are various treatment methods since ejaculation physiology and neuroanatomy is not yet clearly demonstrated. According to neurobiological hypothesis of Waldinger, a dysfunction in the serotonin pathway of the central system such as serotonin-2C hyposensitivity and/or serotonin-1A receptor hypersensitivity is a possible cause of lifelong PE. These experimental animal models showed that serotonergic activity at hypothalamic level inhibited ejaculation reflex. Based on this physiological effect, selective serotonin reuptake inhibitors (SSRI), and serotonin agonists increase intravaginal ejaculation latency time (IELT). A number of studies showed that exercise increased the functional effect of serotonin in the human brain.\n\nThe effects of physical activity level on human health have attracted interest worldwide. Lack of physical activity forms the basis of various health problems, however regular physical act contributes prevention and treatment of a number of disorders.\n\nIn current study, investigators will compare the ejaculation control, IELT, and prevalence of PE between sportsmen that have regular physical activity, and the individuals with a sedentary lifestyle.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The participants are 18-45 year-old, and have regular sexual activity for at least 6 months. A comparison was made by metabolic equivalents (MET), premature ejaculation diagnostic tool (PEDT) and intravaginal ejaculatory latency time (IELT).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-45-year-old\n* sexually active\n* heterosexual,without erectile dysfunction\n* sexual partner for at least six months, and sexual intercourse at least twice a week\n\nExclusion Criteria:\n\n* chronic systemic disorders (such as diabetes or hypertension)\n* use of narcotic/hypnotic drugs or stimulants\n* anabolic steroids\n* selective serotonin receptors inhibitors\n* previous diagnosis and treatment for PE'}, 'identificationModule': {'nctId': 'NCT02984592', 'briefTitle': 'Effect of Exercise on Premature Ejaculation', 'organization': {'class': 'OTHER', 'fullName': 'Ankara Training and Research Hospital'}, 'officialTitle': 'Regular Physical Activity Improves Ejaculation Time and Patient-reported Outcomes', 'orgStudyIdInfo': {'id': '5006'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'The participants in group 1 will state that they participate regular exercise programs in the previous 6 months', 'interventionNames': ['Behavioral: physical exercise']}, {'label': 'Group 2', 'description': 'The participants in group 2 will state that they do not perform any regular exercise in previous 6 months.'}], 'interventions': [{'name': 'physical exercise', 'type': 'BEHAVIORAL', 'description': 'regular exercise programs in the previous 6 months.', 'armGroupLabels': ['Group 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06340', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara Training and Research Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Muhammet Fatih Kilinc', 'investigatorAffiliation': 'Ankara Training and Research Hospital'}}}}