[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"vaginal-prolapse\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:vaginal-prolapse":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,70],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100574035","believe-trial-bulking-versus-sling-for-treating-stress-urinary-incontinence-at-the-time-of-vaginal-prolapse-repair-believe-100574035",false,"NCT06754046","BELIEVE Trial: Bulking vErsus sLing for Treating Stress Urinary IncontinEnce at the Time of Vaginal prolapsE Repair (BELIEVE)","BELIEVE Trial: Bulking vErsus sLing for Treating Stress Urinary IncontinEnce at the Time of Vaginal prolapsE Repair","BELIEVE","Inclusion Criteria:\n\n* Women ≥ 18 years of age.\n* Have diagnosis of symptomatic or occult stress urinary incontinence (SUI) as noted in their electronic health record (EHR).\n* Proof of positive testing for SUI via cough stress test (CST) and\u002For Urodynamic (UDS) testing,\n* Patients that are planning and eligible for native tissue prolapse repair and for both Retropubic Midurethral Sling (RP-MUS) and Polyacrylamide Hydrogel (PAHG)\n\nExclusion Criteria:\n\n* Patients undergoing pelvic organ prolapse repair using mesh or biologic augmentation other than patient's own tissue\n* Patient anticipating difficulty with completing 24-month follow-up\n* Anticipation of pregnancy within subsequent 24-months or \\\u003C18 months post-partum\n* Hemoglobin A1c \\>10.0% within the past 3-months\n* Current smoker \\> 1 pack per week\n* History of neurogenic bladder\n* Current use of any catheterization including but not limited to, intermittent catheterization, indwelling Foley catheter, or suprapubic catheter\n* Post-void residual \\>150 mL felt to not be due to obstruction for prolapse\n* Prior history of any anti-incontinence procedure including but not limited to any synthetic sling, fascial sling, Burch colposuspension or its variants, and urethral bulking\n* Previous history of any pelvic radiation\n* Patient receiving a planned concurrent procedure at the time of prolapse repair.","FEMALE","18 Years",{"count":20,"type":21},476,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to learn if retropubic midurethral sling (RP-MUS) or bulkamide injection (PAHG) at the time of pelvic organ prolapse repair is better from the patient's perspective. The main questions it aims to answer are:\n\nWhat is the average difference in the urogenital distress inventory (UDI) long form score 24 months after surgery for each procedure? Which procedure has the fewest complications and lowest short- and long-term morbidity profile?\n\nParticipants will:\n\nBe blinded and randomized to one of two procedures for the duration of the study, 24 months.\n\nComplete 6 total visits for the clinical trial including validated questionnaires.\n\nFew participants will be selected to complete a qualitative interview at 3 timepoints over 24 month duration of the study.",[27,28],"Stress Urinary Incontinence","Vaginal Prolapse",[30,31,32,33,34],"midurethral sling","bulkamide","polyacrylamide hydrogel","urethral bulking","retropubic sling","RECRUITING","2026-05-27",{"date":38,"type":39},"2026-06-01","ACTUAL",{"date":41,"type":39},"2025-05-01",{"date":43,"type":21},"2029-04",{"name":45,"class":46},"University Hospitals Cleveland Medical Center","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":57,"studyType":58,"phases":4,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":47},"100416314","prospective-observational-prolapse-study-100416314","NCT04701047","Prospective Observational Prolapse Study","Prospective Observational Study with Patient Reported Outcome Measures (PROM) for the Treatment of Vaginal Prolapse: Pessary Vs. Surgery","Inclusion Criteria:\n\n* women with a symptomatic vaginal prolapse\n* older than 18 years\n\nExclusion Criteria:\n\n* under 18 years old\n* undergone a previous treatment with a pessary or surgery for vaginal prolapse\n* contra-indications for surgery or pessary use\n* active or passive child wish\n* not able to understand the Dutch language\n* not able to give a written consent",{"count":56,"type":21},200,"5 Years","OBSERVATIONAL","The rationale of the study is to investigate the results of a prolapse treatment in adult women with a vaginal prolapse. The investigators will investigate this by taking questionnaires in women undergoing a surgical prolapse repair and in women that are being treated by a vaginal pessary. The objective is to compare the results of the different methods with each other and to observe the evolution of the symptoms in patients undergoing surgery or pessary use. The investigators would also like to discover existing problems in pessary use and adverse effects.",[28],"2025-01-13",{"date":63,"type":39},"2025-01-15",{"date":65,"type":39},"2021-09-03",{"date":67,"type":21},"2028-01",{"name":69,"class":46},"University Hospital, Ghent",{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":77,"sex":17,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":82,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":47},"100465024","treatment-of-vaginal-atrophy-with-low-intensity-nanosecond-neodymium-laser-100465024","NCT05335317","Treatment of Vaginal Atrophy With Low Intensity Nanosecond Neodymium Laser","Study of the Efficiency and Safety of Low-Intensity Neodymium Laser Radiation With a Nanosecond Pulse Duration for Treatment of the Vaginal Walls Atrophic Changes","Inclusion Criteria:\n\n* Age of 40-75 years, inclusive;\n* Vaginal atrophy or 1st grade vaginal prolapse with atrophy, or lack of vaginal atrophy in case of control group 2;\n* All participants have informed consent to conduct a course of procedures according to protocol, carry out follow-up visits, and conduct studies.\n\nExclusion Criteria:\n\n* Age of under 40 and over 75 years old;\n* History of oncological diseases;\n* Active tuberculosis;\n* Inflammatory diseases of the vulva and vagina including genital herpes in the acute stage;\n* Urinary tract infections;\n* Damage to the vaginal mucosa;\n* Pregnancy;\n* Tendency to photoallergy including taking photosensitizing drugs (diuretics, antihistamines, antipsychotics);\n* Porphyria;\n* Cardiac deficiency of 2-3 degrees;\n* Chronic renal disease;\n* Participants with greater than 1st grade vaginal prolapse;\n* Women after childbirth up to 8 weeks;\n* Participants who, according to the doctor, are not able to complete the study;\n* Protocol non-compliance of laser exposure sessions;\n* Voluntary refusal to participate in the study;\n* Violation of recommendations for the management of the period after laser treatment;\n* Adverse events that occurred during laser processing and research, and associated with them.\n* The appearance of contraindications listed in the Exclusion criteria.",true,"40 Years","75 Years",{"count":81,"type":21},120,[24],"The aim of study is characteristic of changes in the vaginal wall after treatment of neodymium laser radiation with a wavelength of 1064 nm. To assess the condition of the vaginal walls before and after laser treatment, the following methods will be used: vaginal health index, perineometry, measurement of the vaginal wall thickness by ultrasound, Doppler sonography of the vaginal walls vessels, optical coherence tomography, biopsy, cytological and immunocytochemical methods. The King's Health Questionnaire will be used to collect feedback on changes in the participants life quality. Total up to 100 participants with and 20 participants without postmenopausal atrophy will be involved in the study. Participants will be divided into three groups: laser treatment (study group), topical hormones treatment (control group 1) and no treatment (control group 2) by 70, 30 and 20 participants in each group respectively. The time intervals between special tests and the tests themselves will be the same for all groups. Thus, a direct comparison between conventional treatment (topical hormones), laser treatment of the vaginal atrophy and normal condition without treatment will be made. The main hypothesis of the study is improvement in condition of the vaginal walls after laser treatment compared with the initial state of not less than thirty percent of participants, and improvement in condition on average compared with the control group.",[85,86,28],"Postmenopausal Period","Vaginal Atrophy",[86,28,88,89,90,91,92,93],"Neodymium Laser","Laser Treatment","Nanosecond","Laser","Vaginal","Postmenopausal","2024-12-09",{"date":96,"type":39},"2024-12-12",{"date":98,"type":39},"2022-04-18",{"date":100,"type":21},"2025-12-01",{"name":102,"class":103},"MeLSyTech, Ltd","INDUSTRY"]