Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2026-01-13 @ 11:20 PM
Study NCT ID:
NCT03176069
Status:
COMPLETED
Last Update Posted:
2019-10-07
First Post:
2016-05-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation and Comparison of Women Pelvic Floor With and Without Sexual Dysfunction (Vaginismus)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D052065', 'term': 'Vaginismus'}, {'id': 'D009122', 'term': 'Muscle Hypertonia'}, {'id': 'D009123', 'term': 'Muscle Hypotonia'}], 'ancestors': [{'id': 'D014623', 'term': 'Vaginal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2019-06-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-03', 'studyFirstSubmitDate': '2016-05-12', 'studyFirstSubmitQcDate': '2017-06-01', 'lastUpdatePostDateStruct': {'date': '2019-10-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality sex life', 'timeFrame': '3 months', 'description': 'Female Sexual Function Index'}, {'measure': 'Female Sexual Function', 'timeFrame': '3 months', 'description': 'Sex Index - Female Version (QS-F)'}, {'measure': 'Verification of female anxiety', 'timeFrame': '3 months', 'description': 'Hamilton Anxiety Rating Scale (Ham-A)'}, {'measure': 'Verification of female depression', 'timeFrame': '3 months', 'description': 'Beck Depression Inventory (BDI)'}, {'measure': 'Check Muscle Activity', 'timeFrame': '3 months', 'description': 'Electromyographic biofeedback'}, {'measure': 'Evaluation of Pain', 'timeFrame': '3 months', 'description': 'Functional pain scale'}, {'measure': 'Evaluation of Pain', 'timeFrame': '3 months', 'description': 'Algometry'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vaginismus', 'Muscle Tone', 'Sexual dysfunctions'], 'conditions': ['Vaginismus', 'Sexual Dysfunctions', 'Muscular Hypertonicity', 'Muscle Tone Poor']}, 'referencesModule': {'references': [{'pmid': '25648245', 'type': 'BACKGROUND', 'citation': 'Herbenick D, Schick V, Sanders SA, Reece M, Fortenberry JD. Pain experienced during vaginal and anal intercourse with other-sex partners: findings from a nationally representative probability study in the United States. J Sex Med. 2015 Apr;12(4):1040-51. doi: 10.1111/jsm.12841. Epub 2015 Feb 4.'}, {'pmid': '25293781', 'type': 'BACKGROUND', 'citation': 'Edenfield AL, Levin PJ, Dieter AA, Amundsen CL, Siddiqui NY. Sexual activity and vaginal topography in women with symptomatic pelvic floor disorders. J Sex Med. 2015 Feb;12(2):416-23. doi: 10.1111/jsm.12716. Epub 2014 Oct 8.'}, {'pmid': '16020150', 'type': 'BACKGROUND', 'citation': 'Rosenbaum TY. Physiotherapy treatment of sexual pain disorders. J Sex Marital Ther. 2005 Jul-Sep;31(4):329-40. doi: 10.1080/00926230590950235.'}, {'pmid': '21400333', 'type': 'BACKGROUND', 'citation': 'Rosenbaum T. Addressing anxiety in vivo in physiotherapy treatment of women with severe vaginismus: a clinical approach. J Sex Marital Ther. 2011;37(2):89-93. doi: 10.1080/0092623X.2011.547340.'}, {'pmid': '16551154', 'type': 'BACKGROUND', 'citation': 'van Lankveld JJ, ter Kuile MM, de Groot HE, Melles R, Nefs J, Zandbergen M. Cognitive-behavioral therapy for women with lifelong vaginismus: a randomized waiting-list controlled trial of efficacy. J Consult Clin Psychol. 2006 Feb;74(1):168-78. doi: 10.1037/0022-006X.74.1.168.'}, {'pmid': '15672966', 'type': 'BACKGROUND', 'citation': 'Addar MH. The unconsummated marriage: causes and management. Clin Exp Obstet Gynecol. 2004;31(4):279-81.'}, {'pmid': '20887170', 'type': 'BACKGROUND', 'citation': 'Lahaie MA, Boyer SC, Amsel R, Khalife S, Binik YM. Vaginismus: a review of the literature on the classification/diagnosis, etiology and treatment. Womens Health (Lond). 2010 Sep;6(5):705-19. doi: 10.2217/whe.10.46.'}, {'pmid': '25470078', 'type': 'BACKGROUND', 'citation': 'Aydin S, Arioglu Aydin C, Batmaz G, Dansuk R. Effect of vaginal electrical stimulation on female sexual functions: a randomized study. J Sex Med. 2015 Feb;12(2):463-9. doi: 10.1111/jsm.12788. Epub 2014 Dec 3.'}, {'pmid': '13688369', 'type': 'BACKGROUND', 'citation': 'BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. doi: 10.1001/archpsyc.1961.01710120031004. No abstract available.'}, {'pmid': '8579326', 'type': 'BACKGROUND', 'citation': 'Biswas A, Ratnam SS. Vaginismus and outcome of treatment. Ann Acad Med Singap. 1995 Sep;24(5):755-8.'}, {'pmid': '25855126', 'type': 'BACKGROUND', 'citation': 'Bortolami A, Vanti C, Banchelli F, Guccione AA, Pillastrini P. Relationship between female pelvic floor dysfunction and sexual dysfunction: an observational study. J Sex Med. 2015 May;12(5):1233-41. doi: 10.1111/jsm.12882. Epub 2015 Apr 8.'}, {'pmid': '16967145', 'type': 'BACKGROUND', 'citation': 'De Lorenzi DR, Saciloto B. [Factors related to frequency of sexual activity of postmenopausal women]. Rev Assoc Med Bras (1992). 2006 Jul-Aug;52(4):256-60. doi: 10.1590/s0104-42302006000400027. Portuguese.'}, {'pmid': '20390584', 'type': 'BACKGROUND', 'citation': 'Engman M, Wijma K, Wijma B. Long-term coital behaviour in women treated with cognitive behaviour therapy for superficial coital pain and vaginismus. Cogn Behav Ther. 2010;39(3):193-202. doi: 10.1080/16506070903571014.'}, {'pmid': '19440781', 'type': 'BACKGROUND', 'citation': 'Kingsberg S, Althof SE. Evaluation and treatment of female sexual disorders. Int Urogynecol J Pelvic Floor Dysfunct. 2009 May;20 Suppl 1:S33-43. doi: 10.1007/s00192-009-0833-x.'}, {'pmid': '20388160', 'type': 'BACKGROUND', 'citation': 'Lewis RW, Fugl-Meyer KS, Corona G, Hayes RD, Laumann EO, Moreira ED Jr, Rellini AH, Segraves T. Definitions/epidemiology/risk factors for sexual dysfunction. J Sex Med. 2010 Apr;7(4 Pt 2):1598-607. doi: 10.1111/j.1743-6109.2010.01778.x.'}, {'pmid': '23235583', 'type': 'BACKGROUND', 'citation': 'Melnik T, Hawton K, McGuire H. Interventions for vaginismus. Cochrane Database Syst Rev. 2012 Dec 12;12(12):CD001760. doi: 10.1002/14651858.CD001760.pub2.'}, {'pmid': '24066697', 'type': 'BACKGROUND', 'citation': 'Pereira VM, Arias-Carrion O, Machado S, Nardi AE, Silva AC. Sex therapy for female sexual dysfunction. Int Arch Med. 2013 Sep 26;6(1):37. doi: 10.1186/1755-7682-6-37.'}, {'pmid': '14739686', 'type': 'BACKGROUND', 'citation': 'Reissing ED, Binik YM, Khalife S, Cohen D, Amsel R. Vaginal spasm, pain, and behavior: an empirical investigation of the diagnosis of vaginismus. Arch Sex Behav. 2004 Feb;33(1):5-17. doi: 10.1023/B:ASEB.0000007458.32852.c8.'}, {'pmid': '22024357', 'type': 'BACKGROUND', 'citation': 'Reissing ED. Consultation and treatment history and causal attributions in an online sample of women with lifelong and acquired vaginismus. J Sex Med. 2012 Jan;9(1):251-8. doi: 10.1111/j.1743-6109.2011.02534.x. Epub 2011 Oct 24.'}, {'pmid': '10782451', 'type': 'BACKGROUND', 'citation': "Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, Ferguson D, D'Agostino R Jr. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000 Apr-Jun;26(2):191-208. doi: 10.1080/009262300278597."}, {'pmid': '17433086', 'type': 'BACKGROUND', 'citation': 'Segraves R, Balon R, Clayton A. Proposal for changes in diagnostic criteria for sexual dysfunctions. J Sex Med. 2007 May;4(3):567-580. doi: 10.1111/j.1743-6109.2007.00455.x. Epub 2007 Apr 13.'}, {'pmid': '15992873', 'type': 'BACKGROUND', 'citation': 'Seo JT, Choe JH, Lee WS, Kim KH. Efficacy of functional electrical stimulation-biofeedback with sexual cognitive-behavioral therapy as treatment of vaginismus. Urology. 2005 Jul;66(1):77-81. doi: 10.1016/j.urology.2005.01.025.'}, {'pmid': '23805463', 'type': 'BACKGROUND', 'citation': 'Sirakov M. [Vaginismus and our experience in treating this sexual problem]. Akush Ginekol (Sofiia). 2013;52(1):61-6. Bulgarian.'}]}, 'descriptionModule': {'briefSummary': 'Sexuality is considered one of the pillars of quality of life, an integral part of the personality of each individual. Being a basic human being need, it cannot be separated from other aspects of life. For several centuries and until recently, sexuality was considered the "lower instincts" expression related only to the sexual act. Sex is associated with "reproduction" of the sexual energy. On the other hand, the exercise of sexuality includes various factors such as the building of the sensitivity between individuals like touch, dance, fantasy, look, etc. For a long time feminine sexuality was predominantly focused on procreation and has only recently been considered as an integral part of sexual and reproductive rights of women. Vaginismus is a female sexual dysfunction that affects the quality of sexual and psychosocial lives of women, influencing the quality of the couple\'s relationship. The scientific literature emphasizes the importance of the examination, diagnosis and physical therapy for this dysfunction, but until now there is no quantification or evaluation of the pelvic floor muscles for this group of women, which justifies the realization of this project.', 'detailedDescription': "Psychosocial, cultural and relational factors, frequently influenced by a rigid education, have been related to the etiology of sexual difficulties. Women with stable partners who maintain an no consummated pattern of sexual intercourse (vaginismus) reveal a history of sexual life affected by these factors.\n\nVaginismus is a female sexual dysfunction that affects the quality of sexual and psychosocial lives of women. It may influence both the quality of the couple's relationship and the overall emotional and motivational state of people in their daily activities.\n\nThere is a concordance in the scientific literature that physiotherapy is of high importance in the treatment of vaginismus. The scientific literature presents some studies confirming its importance and highlighting the satisfactory results obtained at posttreatment of these dysfunctions.\n\nConsidering the impact of vaginismus in the sexual life of couples, as well as the relevance of the development of wide-ranging intervention models in the treatment of this disorder, it is appropriate to conduct this study in order to identify and recognize parameters of muscle tonus of women with and without a diagnosis of vaginismus and also to study the effectiveness of physiotherapy resources applied in the treatment of vaginismus.\n\nObjectives\n\n1. Evaluate and compare the pelvic floor musculature of women with and without a diagnosis of vaginismus, by algometry and perineal electromyographic biofeedback;\n2. Evaluate and compare the parameters of muscle tonus of the pelvic floor by perineal electromyographic biofeedback in women with and without a diagnosis of vaginismus;\n3. Evaluate the pelvic floor musculature of women diagnosed with vaginismus, through algometry and electromyographic biofeedback, after the physiotherapeutic treatment;\n4. Evaluate the quality of sexual life and sexual function of women with and without a diagnosis of vaginismus;\n5. Evaluate the quality of sexual life and sexual function of women diagnosed with vaginismus, after physiotherapeutic treatment."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female\n* Sexual orientation - heterosexual\n* Be in a stable relationship for at least six months\n* Present vaginismus\n* Did not initiated and/or performed previous vaginismus treatment\n* Elementary school level\n* Be available for weekly attendance at ambulatory\n\nExclusion Criteria:\n\n* Severe psychiatric illness (psychosis) or physical incapacity (previous or current)\n* Vaginismus, whose characteristics suggest the need for surgical treatment\n* Cognitive downgrade\n* Absence of a stable relationship\n* Partner with sexual dysfunction that prevents penetration\n* Presence of genital prolapse'}, 'identificationModule': {'nctId': 'NCT03176069', 'briefTitle': 'Evaluation and Comparison of Women Pelvic Floor With and Without Sexual Dysfunction (Vaginismus)', 'organization': {'class': 'OTHER', 'fullName': 'Faculdade de Ciências Médicas da Santa Casa de São Paulo'}, 'officialTitle': 'Evaluation and Comparison of Women Pelvic Floor With and Without Sexual Dysfunction (Vaginismus)', 'orgStudyIdInfo': {'id': '51995515.4.0000.5479'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A - women diagnosed with vaginismus', 'description': 'All patients will be submitted to anamnesis, physical examination, examination of the pelvic floor. The algometry will be performed with patient will be lying in a supine position (belly up), with the pelvis in a neutral position, back at 45º and feet supported in stirrups, for the verification the perineal pain threshold.\n\nThe available treatment tools are educational, behavioral and rehabilitating. The physiotherapeutic treatment will consist of the following features:\n\nKinesiotherapy Manual therapy Electrotherapy (electric electrostimulation, ultrasound) Behavioral therapy', 'interventionNames': ['Other: The physiotherapeutic treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B - women without a diagnosis of vaginismus', 'description': 'All patients will be submitted to anamnesis, physical examination, examination of the pelvic floor. The algometry will be performed with patient will be lying in a supine position (belly up), with the pelvis in a neutral position, back at 45º and feet supported in stirrups, for the verification the perineal pain threshold.', 'interventionNames': ['Other: Evaluation and Comparison of women pelvic floor with and without sexual dysfunction']}], 'interventions': [{'name': 'Evaluation and Comparison of women pelvic floor with and without sexual dysfunction', 'type': 'OTHER', 'description': 'Pelvic floor muscles will also be evaluated by electromyographic biofeedback.', 'armGroupLabels': ['Group B - women without a diagnosis of vaginismus']}, {'name': 'The physiotherapeutic treatment', 'type': 'OTHER', 'description': 'The available treatment tools are educational, behavioral and rehabilitating. The physiotherapeutic treatment will consist of the following features:\n\n* Kinesiotherapy\n* Manual therapy\n* Electrotherapy (electric electrostimulation, ultrasound)\n* Behavioral therapy', 'armGroupLabels': ['Group A - women diagnosed with vaginismus']}]}, 'contactsLocationsModule': {'locations': [{'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Santa Casa of Sao Paulo Medical School', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Faculdade de Ciências Médicas da Santa Casa de São Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Profa. Dra. Vera Lúcia dos Santos Alves', 'investigatorAffiliation': 'Faculdade de Ciências Médicas da Santa Casa de São Paulo'}}}}