[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"vaginal-stenosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:vaginal-stenosis":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,76],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":32,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100609582","vaginal-dilator-therapy-after-pelvic-radiation-100609582",false,"NCT07216456","Vaginal Dilator Therapy After Pelvic Radiation","Improving Engagement With Vaginal Dilator Therapy After Pelvic Radiation: A Pilot Randomized Controlled Trial","Inclusion Criteria:\n\n* female sex\n* adults aged 18 years or older\n* diagnosed with cancer of the anus, anal canal, anorectum, cervix, uterus, vagina, vulva, and\u002For bladder\n* completed pelvic radiation therapy in the past year\n* dilator therapy recommended by medical provider and standardized dilator received from provider\n* able to speak\u002Fread English\n\nExclusion Criteria:\n\n* aged less than 17 years\n* under the care of a pelvic floor physical therapist at the time of study enrollment\n* have a major\u002Fserious psychiatric concern (e.g., schizophrenia) as indicated by medical chart\u002Fmedical provider\n* inability to provide consent","FEMALE","18 Years",{"count":19,"type":20},88,"ESTIMATED","INTERVENTIONAL",[23],"NA","This study is testing a new program to help women who have had pelvic radiation therapy to use vaginal dilators more regularly. Vaginal dilators are important tools that can help prevent or treat vaginal narrowing (called vaginal stenosis), which can happen after radiation and make medical exams or sexual activity painful or difficult. Even though dilators are recommended, many women don't use them as often as needed.\n\nIn this study, 88 participants will be randomly assigned to one of two groups:\n\n* One group will receive the new behavioral program, which includes support and strategies to help with regular dilator use.\n* The other group will receive written educational materials (enhanced usual care).\n\nThe study will look at how often and how long participants use their dilators, and whether the program helps reduce symptoms like pain or emotional distress. Participants will complete surveys at the beginning of the study and again at 3, 6, and 9 months, plus short monthly check-ins.\n\nThe goal is to see if the program is helpful and easy to use, and to prepare for a larger study in the future.",[26,27,28,29,30,31],"Pelvic Radiotherapy","Vaginal Stenosis","Pelvic Cancer","Gynecologic Cancers","Anorectal Cancer","Urologic Cancer",[33,34],"vaginal dilator therapy","pelvic radiation","NOT_YET_RECRUITING","2025-10-13",{"date":38,"type":39},"2025-10-15","ACTUAL",{"date":41,"type":20},"2027-08-01",{"date":43,"type":20},"2030-04-30",{"name":45,"class":46},"Duke University","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":47},"100439473","quantifying-radiation-induced-vaginal-stenosis-100439473","NCT05002751","Quantifying Radiation Induced Vaginal Stenosis","Quantifying Radiation Induced Vaginal Stenosis for the Development of a Novel Dilator Device","QRIVS","Inclusion Criteria:\n\n* Patients with histologically confirmed newly diagnosed advanced cervical cancer (squamous cell carcinoma, adenocarcinoma, and adenosquamous cell carcinoma): FIGO 2009 clinical stages IB2\u002FIIA with positive para-aortic nodes, or FIGO 2009 clinical stages IIB\u002FIIIB\u002FIVA with positive pelvic or para-aortic lymph nodes (PALN). Pelvic or PALN nodal status confirmed by PET\u002FCT scan or fine needle biopsy or extra peritoneal biopsy or laparoscopic biopsy. The PALN must be inferior to the T12\u002FL1 interspace.\n* ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix II).\n* Patients must have normal organ and marrow function as defined below:\n\n  1. leukocytes ≥2,500\u002FmcL\n  2. absolute neutrophil count ≥1,500\u002FmcL\n  3. platelets ≥100,000\u002FmcL\n  4. hemoglobin ≥8 g\u002FdL (can be transfused with red blood cells pre- study)\n  5. total bilirubin ≤1.5 × institutional upper limit of normal (ULN)\n  6. AST(SGOT)\u002FALT(SGPT) ≤3 × ULN\n  7. alkaline phosphatase ≤2.5 × ULN\n  8. creatinine \\\u003C1.5 mg\u002FdL INR and aPTT ≤1.5 × ULN (This applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation, such as low-molecular-weight heparin or warfarin, should be on a stable dose.)\n* Age is \\> 18 years.\n* Patient does not have a known allergy to cisplatin or compounds of similar biologic composition.\n* Ability to understand and the willingness to sign a written informed consent document.\n* Patients positive for human immunodeficiency virus (HIV) are allowed on study, but HIV-positive patients must have:\n* A stable regimen of highly active anti-retroviral therapy (HAART)\n* No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections\n* A CD4 count above 250 cells\u002FmcL and an undetectable HIV viral load on standard PCR-based tests.\n\nExclusion Criteria:\n\n* Patients who have received prior radiation therapy to the pelvis or abdominal cavity, PALN radiation, or previous therapy of any kind for this malignancy or pelvic, PALN, or abdominal radiation for any prior malignancy.\n* Patients with PALN nodal metastasis above the T12\u002FL1 interspace.\n* Patients who had a radical hysterectomy with positive PALNs are not eligible.\n* Patients with prior allogeneic bone marrow transplantation or prior solid organ transplantation.\n* Patients previously treated with systemic anticancer therapy (e.g., chemotherapy, targeted therapy, immunotherapy) within 3 years prior to entering the study.\n* Patients diagnosed on imaging or biopsy with a synchronous primary malignancy (with the exception of DCIS of the breast, or early stage basal cell carcinoma of the skin)\n\n  a. transcription mediated amplification (TMA) or branched DNA testing.\n* History or risk of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's","99 Years",{"count":58,"type":20},12,"OBSERVATIONAL","Radiation (RT) affects the vagina by narrowing, tightening and scarring, termed vaginal stenosis (VS). VS occurs in up to 88% of patients treated with radiation for cervical cancer. VS is not well characterized in measurements. There is a lack of understanding of how short and tight the vagina becomes after RT. This study will use specific measurements of the vagina during the routine physician physical exam after RT in the follow up periods: after RT, 3 months, 6 months, and 12 months using a plastic commercial dilator set and length and width measurements.\n\nIn addition, the study use a validated sexual health survey and a specific survey on vaginal dilation preferences to help stop VS after RT.",[62,27],"Vaginal Stricture",[27,62,64,65],"Radiotherapy Side Effect","Brachytherapy Side Effect","RECRUITING","2025-07-07",{"date":69,"type":39},"2025-07-09",{"date":71,"type":39},"2022-10-06",{"date":73,"type":20},"2027-02-28",{"name":75,"class":46},"University of California, San Diego",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":21,"phases":84,"briefSummary":85,"conditions":86,"keywords":90,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":47},"100489064","feasibility-of-hyivy-device-post-radiation-for-pelvic-malignancies-100489064","NCT05648253","Feasibility of Hyivy Device Post-Radiation for Pelvic Malignancies","Pilot Study to Assess the Feasibility of Use of a Novel Vaginal Dilator Device Post-radiation for Patients With Pelvic Malignancies","Inclusion Criteria:\n\n* 1.Age ≥ 18 at the time of enrollment\n* 2.Patient with a vagina or vaginal canal who have completed radiation therapy (either external beam or brachytherapy, or a combination of both) for endometrial cancer, cervical cancer, anal cancer, or rectal cancer, without concomitant chemotherapy\n* 3.Generally in good health (other than due to cancer), at the discretion of the investigator(s)\n* 4.Eastern Cooperative Oncology Group (ECOG) score or 0 to 2\n* 5.Participants must be post-menopausal (natural or surgically) for at least 1 year prior to screening or be surgically sterile (absence of ovaries and\u002For uterus); or, a participant of child-bearing potential must agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months.\n* 6.Agree not to use other dilators for the 12-week intervention period\n* 7.Must have the ability to charge the investigational device\n* 8.Must be willing and able to insert intravaginal device\n* 9.Able to understand, comply and consent to protocol requirements and instructions\n* 10.Able to attend scheduled study visits and complete required investigations\n* 11.Ability to understand and willingness to sign written informed consent\n\nExclusion Criteria:\n\n* 1.Participants who are pregnant or planning to become pregnant during the trial\n* 2.Any major surgery in the past 3 months unless post-surgery dilator use is recommended by a physician, or anticipates having a major surgery during the study\n* 3.Any other medical condition or clinical finding giving reasonable suspicion of a disease or condition that contraindicates the use of the investigational product or that may affect the interpretation of the results or leave the patient at high risk from treatment complications, at the discretion of the investigator(s)\n* 4.Allergy to Hyivy device's materials\n* 5.Active pelvic or gynaecological infection\n* 6.Current use of antibiotics for any infection\n* 7.Have open wounds, cuts, or open sores present in the vaginal or pelvic area\n* 8.Severe atrophic vaginitis or very dry, itchy, or sore vagina\u002Fvaginal area, at the discretion of the investigator(s)\n* 9.Hypoesthesia or loss in sensation of the pelvic floor\n* 10.Total and\u002For partial prolapse of the uterus and\u002For vagina\n* 11.Symptoms of severe urinary retention, severe extra-urethral incontinence, or overflow incontinence\n* 12.Unable to position the device according to directions for use\n* 13.Use of any medical devices that may interfere with the investigational device's function, such as pacemakers, ventilators, and ear implants",{"count":58,"type":20},[23],"Vaginal dilator therapy (VDT) with static dilators is often prescribed to patients following vaginal or pelvic radiation therapy. This study seeks to evaluate the feasibility of a novel intravaginal device that delivers patient-controlled dilation (Hyivy device). The study is designed as a proof-of-concept single-arm pilot study. The primary objective is to assess safety and tolerability, while also evaluating changes in health-related quality of life and pelvic pain.",[27,87,88,89,28],"Radiation Therapy","Cancer","Pelvic Pain",[91,92],"Dilator","Post radiation therapy","2025-04-17",{"date":95,"type":39},"2025-04-22",{"date":97,"type":39},"2025-04-11",{"date":99,"type":20},"2026-06",{"name":101,"class":102},"Hyivy Health Inc","INDUSTRY"]