[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100466525":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":38,"centralContacts":42,"locations":52,"responsibleParty":73,"collaborators":46,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":46,"eligibilityCriteria":82,"healthyVolunteers":78,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":46,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":55,"whyStopped":46,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"University of California, Los Angeles","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Usual Care","ACTIVE_COMPARATOR","The current standard, first line treatment for MPP is a program of education, home exercises, and stretching. At enrollment, subjects will be counseled about the origins of myofascial pain in a one-on-one setting with the aid of informational handouts. They will be counseled about specific practices, such as Kegel exercises, volitional holding of urine or stool, and intensive exercise, that aggravate pelvic floor hypertonicity. They will be counseled about appropriate hydration and maintaining an adequate bowel regimen to avoid constipation. A stretching regimen aimed at abdominal and pelvic muscle release with elements of self-massage should be performed three times daily. Lastly, subjects will be prescribed 20 minutes of walking daily. Subjects will be recommended to continue this long-term, self-care program indefinitely.",[13],"Behavioral: Standard care",{"label":15,"type":10,"description":16,"interventionNames":17},"HF-TES by LVN","In-office pulsed HF-TES will be delivered by licensed vocational nurse using the Urostym® clinic-based Pelvic Floor Rehabilitation System. An LVN will undergo didactic and practical training, which will include a detailed orientation to the device.\n\nSessions of electric muscle stimulation will be performed at a frequency of 200 Hz (to induce a passive pelvic floor muscle contraction) for 20 min weekly using a pulse duration of 1 ms of stimulation and an interpulse interval of 4.1 ms. Stimulation intensity (current) will be adjusted manually to palpable, but not painful, stimulation. Vaginal and surface abdominal electromyographic monitoring (EMG) will be conducted throughout the treatment session, recording the average pre- and post-treatment values for each session. In subjects whose pelvic floor EMG does not normalize to \\\u003C4 millielectronvolts (mV) in a 20-minute session, the subsequent session will be increased to 30 minutes.",[18],"Device: Urostym",{"label":20,"type":10,"description":21,"interventionNames":22},"HF-TES by Physician","A urogynecologic specialist will deliver HF-TES in office using Urostym® pelvic floor rehabilitation system. A physician will undergo didactic and practical training, which will include a detailed orientation to the device.\n\nSessions of electric muscle stimulation will be performed at a frequency of 200 Hz (to induce a passive pelvic floor muscle contraction) for 20 min weekly using a pulse duration of 1 ms of stimulation and an interpulse interval of 4.1 ms. Stimulation intensity (current) will be adjusted manually to palpable, but not painful, stimulation. Vaginal and surface abdominal electromyographic monitoring (EMG) will be conducted throughout the treatment session, recording the average pre- and post-treatment values for each session. In subjects whose pelvic floor EMG does not normalize to \\\u003C4 millielectronvolts (mV) in a 20-minute session, the subsequent session will be increased to 30 minutes.",[18],[24,31],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DEVICE","Urostym","electric pelvic floor muscle stimulator",[15,20],[30],"Hi frequency transvaginal electrical stimulation",{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"BEHAVIORAL","Standard care","patient education on home exercises and stretching",[9],[37],"usual care",[39],{"name":40,"affiliation":5,"role":41},"A. Lenore Ackerman, MD, PhD","PRINCIPAL_INVESTIGATOR",[43,48],{"name":40,"role":44,"phone":45,"phoneExt":46,"email":47},"CONTACT","833-825-2974",null,"aackerman@mednet.ucla.edu",{"name":49,"role":44,"phone":50,"phoneExt":46,"email":51},"Katie Levitt","3107946786","klevitt@mednet.ucla.edu",[53],{"facility":54,"status":55,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"UCLA Center for Women's Pelvic Health","RECRUITING","Los Angeles","California","90095","United States","US",{"type":62,"coordinates":63},"Point",[64,65],-118.24368,34.05223,{"lat":65,"lon":64},[68,70,72],{"name":40,"role":44,"phone":69,"phoneExt":46,"email":47},"8338252974",{"name":49,"role":44,"phone":71,"phoneExt":46,"email":51},"310-794-6786",{"name":40,"role":41,"phone":46,"phoneExt":46,"email":46},{"type":41,"investigatorFullName":74,"investigatorTitle":75,"investigatorAffiliation":5,"oldNameTitle":46,"oldOrganization":46},"Anne Lenore Ackerman","Assistant Professor of Urology and Director of Research","100466525","transvaginal-electrical-stimulation-for-myofascial-pelvic-pain-100466525",false,"NCT05354869","Transvaginal Electrical Stimulation for Myofascial Pelvic Pain","Repurposing Pelvic Floor Electrical Stimulation for the Treatment of Chronic Pelvic Pain","Inclusion Criteria:\n\n* Women between 18 and 65 years of age\n* Pelvic pain for more than 6 months duration\n* Report an average daily pain intensity score of at least 4 (on a 0 to 10 scale)\n* Palpable trigger points in internal pelvic floor muscles on standardized myofascial pelvic floor exam\n* Willing to refrain from new clinical treatments that may affect pain during the study period\n\nExclusion Criteria:\n\n* Inability to participate in weekly clinic visits\n* Prior invasive pelvic procedures for pain (e.g., prior pelvic surgery, sacroiliac joint injections, ganglion impar block, bladder instillations, sacral neuromodulation, intradetrusor or intramuscular Botox®)\n* Active urinary tract infection (UTI) or vaginal infection\n* Pregnancy, childbirth during the previous12 months, currently planning pregnancy\n* Drug addiction\n* Prior pelvic floor physical therapy\n* Malignancy or other serious medical condition (e.g., poorly controlled diabetes \\[Glycated hemoglobin (HgA1c) \\> 8\\], neurologic or rheumatic disease)\n* Diagnosed with an alternate cause of pelvic pain (e.g., interstitial cystitis, dysmenorrhea\u002Fmenorrhalgia, vestibulodynia, vulvar dermatoses)\n* Urinary retention\n* Greater than stage 3 pelvic organ prolapse\n* Indwelling vaginal devices (e.g., vaginal pessary, contraceptive ring)\n* Inability to sign an informed consent, fill out questionnaires, or complete study interviews","FEMALE","18 Years","65 Years",{"count":87,"type":88},60,"ESTIMATED","INTERVENTIONAL",[91],"NA","Myofascial Pelvic Pain (MPP) is a frequently overlooked musculoskeletal cause of chronic pelvic pain affecting 10-20% of all adult women. Despite high prevalence and societal costs, few effective treatments exist and are difficult to access due to shortages of skilled personnel. Treatments for MPP using electrical stimulation to induce muscle fatigue have proven efficacy at reducing pain, improving circulation, and promoting tissue healing, but have proven difficult to implement in gynecologic practice. The aim of this three-arm randomized study is to evaluate the utility of transvaginal electrical stimulation at a fixed frequency of 200 Hz in women with symptomatic MPP in comparison to the standard, first-line treatment with education, stretching, and low-impact exercise.\n\nNursing staff without prior training will be taught to deliver this high-frequency transvaginal electrical stimulation (HF-TES) treatment using the device. Responses to treatment provided by a specialist physician and licensed vocational nurse will be compared. Patients with \\>50% pain improvement will determine the effectiveness of HF-TES. Responses to treatment provided by a specialist physician and licensed vocational nurse will also be compared. Participants will be followed for 3 months following treatment completion.",[94],"Myofascial Pelvic Pain",[96,97,98,99],"high frequency transvaginal electrical stimulation","pelvic floor","chronic pelvic pain","muscle fatigue","2026-04-06",{"date":102,"type":103},"2026-04-13","ACTUAL",{"date":105,"type":103},"2022-10-31",{"date":107,"type":88},"2026-12",{"name":5,"class":6},1]