Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-25 @ 5:16 PM
Study NCT ID:
NCT05806203
Status:
UNKNOWN
Last Update Posted:
2023-11-28
First Post:
2023-02-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Participants Ages 21-65 Diagnosed With Dyspareunia and the Effects of Low Intensity Shockwave Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-21', 'studyFirstSubmitDate': '2023-02-21', 'studyFirstSubmitQcDate': '2023-04-07', 'lastUpdatePostDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tampon Test', 'timeFrame': 'up to 6 weeks', 'description': 'A self-reported measurement of pain on a numeric scale from 0 to 10, with 0 signifying no pain and 10 signifying extreme pain.'}, {'measure': 'Numerical pain rating scale for tampon test', 'timeFrame': 'up to 6 weeks', 'description': 'A self-reported measurement of pain on a numeric scale from 1 to 10, with 0 signifying no pain and 10 signifying extreme pain.'}, {'measure': 'Female Sexual Function Index, (FSFI)', 'timeFrame': 'up to 6 weeks', 'description': 'A validated, self-reported questionnaire assessing different domains of female sexual function including desire, arousal, lubrication, orgasm, satisfaction, and pain. Scores range from 2.0 to 36.0. Lower scores indicate greater risk of female sexual dysfunction, and higher scores indicate better outcomes in overall sexual function.'}], 'secondaryOutcomes': [{'measure': 'Numeric pain score for deep penetration.', 'timeFrame': 'Completed once per week for 4 to 6 weeks', 'description': 'A self-reported measurement of pain on a numeric scale from 1 to 10, with 0 signifying no pain and 10 signifying extreme pain.'}, {'measure': 'Beck Depression Scale', 'timeFrame': 'Completed once per week for 4 to 6 weeks', 'description': 'Sel-reported scale consisting of 21 items of emotional, behavioral, and somatic symptoms. Scoring ranges from 0, (no symptoms) to 27, (severe symptoms).'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Female Dyspareunia']}, 'descriptionModule': {'briefSummary': 'Dyspareunia is defined as a complaint of persistent or recurring pain or discomfort associated with attempted or complete vaginal penetration\n\ne purpose of this study is to determine the effectiveness of low intensity shockwave treatment for patients with dyspareunia and their ability to tolerate sexual activity, (i.e., penetration of vagina, self or partnered pleasure).\n\nParticipants will:\n\n* Be given a preliminary physical therapy examination and evaluation.\n* Be asked to attend weekly low intensity shockwave treatment visits.\n* Be asked to complete 3 Month follow up questionnaires', 'detailedDescription': 'This study seeks to determine the effectiveness of low intensity shockwave (LiSWT) for patients with dyspareunia, with the primary objective being the ability to tolerate penetration of the vagina and sexual activity, (self or partnered pleasure). A secondary objective of the study is an improved quality of life.\n\nThis is a single blind, randomized controlled trial, with randomized placebo phase design.\n\nA total of 60 participants enrolled at 4 clinical sites will be blinded to the group they are assigned to, (treatment or sham). Clinical investigators cannot be blinded to treatment or sham in order to deliver the treatment.\n\nThere are two arms of the study: the Intervention arm where subjects receive active low intensity shockwave treatment plus typical physical therapy. Intervention is the delivery of shockwaves to the pelvic floor region using Softwave Tissue RegenerationTechnologies OrthoGold 100 MTS OP155 unfocused parabolic probe electrohydraulic device.\n\nThe Control arm subjects receive sham shockwave treatment plus typical physical therapy.\n\nEach clinical site will have an envelope with pre-determined even and odd numbers determining randomization. Upon enrollment a random number from the envelope will be drawn and assigned to the participant.\n\nAt 4-6 weeks participants in the control arm will be given the option of moving to the shockwave (intervention) arm. Participants will spend 4 to 4 1/2 months in the study receiving treatment once per week, 4-6 weeks duration for both treatment arms. Subjects will then be contacted for a 3-month follow-up by phone completing their study participation.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'genderBased': True, 'genderDescription': 'Cisgender female or have natal vaginal tissue', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary diagnosis of dyspareunia (pain with intercourse and/or vaginal penetration)\n* Cisgender female or have natal vaginal tissu\n* Has not started hormonal therapy within the past 2 weeks\n* Has not received pelvic floor physical therapy within the past 2 weeks\n* Is able to electronically access informed consent and outcomes measures forms\n\nExclusion Criteria:\n\n* Have a diagnosis of lichen sclerosis\n* Have an active infection (e.g. herpes)\n* Are earlier than 12 weeks post-surgery\n* Are earlier than 6 weeks postpartum\n* Have a history of gynecological cancer\n* Have a history of pelvic radiation\n* Are actively undergoing cancer treatments\n* Are currently pregnant\n* Currently using lidocaine or cortisone'}, 'identificationModule': {'nctId': 'NCT05806203', 'briefTitle': 'A Study of Participants Ages 21-65 Diagnosed With Dyspareunia and the Effects of Low Intensity Shockwave Treatment', 'organization': {'class': 'INDUSTRY', 'fullName': 'SoftWave Tissue Regeneration Technologies'}, 'officialTitle': 'Randomized Controlled Trial for Use of Low Intensity Shockwave for Patients With Dyspareunia', 'orgStudyIdInfo': {'id': '2018453-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Low Intensity plus PT', 'description': 'Participants receive active low intensity shockwave treatment from plus typical physical therapy.', 'interventionNames': ['Device: Low intensity shockwave treatment to pelvic floor region plus typical physical therapy']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Shockwave Treatment plus PT', 'description': 'Participant receives sham shockwave treatment plus typical physical therapy.', 'interventionNames': ['Device: Sham shockwave treatment plus typical physical therapy']}], 'interventions': [{'name': 'Low intensity shockwave treatment to pelvic floor region plus typical physical therapy', 'type': 'DEVICE', 'description': 'Treatment dose: 1,000 - 1,500 shocks, 2.5-3.0 Hz, 0.06-0.10 mJ/mm2 (Intensity of 6-8), 8 to 12 minutes', 'armGroupLabels': ['Low Intensity plus PT']}, {'name': 'Sham shockwave treatment plus typical physical therapy', 'type': 'DEVICE', 'description': 'Inactive dose of shockwave treatment', 'armGroupLabels': ['Sham Shockwave Treatment plus PT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53226', 'city': 'Wauwatosa', 'state': 'Wisconsin', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Stacey Roberts', 'role': 'CONTACT', 'email': 'staceyr@newyouhealthandwellness.com', 'phone': '414-299-8121'}], 'facility': 'New You Health and Wellness', 'geoPoint': {'lat': 43.04946, 'lon': -88.00759}}], 'centralContacts': [{'name': 'Stacey Roberts', 'role': 'CONTACT', 'email': 'staceyroberts22@gmail.com', 'phone': '414-299-8121'}, {'name': 'Christine Calbelka', 'role': 'CONTACT', 'email': 'ccabelka@css.edu', 'phone': '218-723-6122'}], 'overallOfficials': [{'name': 'Stacey Roberts', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SoftWave Tissue Regeneration Technologies', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}