[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"prolapse\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:prolapse":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,82],{"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":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100564844","pomegranate-trial-comparing-reia-pessary-versus-standard-of-care-pessary-for-pelvic-organ-prolapse-treatment-100564844",false,"NCT06634459","POMEGRANATE Trial: Comparing Reia Pessary Versus Standard of Care Pessary for Pelvic Organ Prolapse Treatment","The POMEGRANATE Trial: A Randomized Controlled Trial Comparing Pessary Home Management of Reia Pessary Versus Standard of Care Pessary for Treatment of Pelvic Organ Prolapse","POMEGRANATE","Inclusion Criteria:\n\n* English-speaking natal females ≥ 18 years of age\n* Willing to self-maintain (insert\u002Fremove) pessary\n* Pessary naïve with Stage II-IV POP desiring conservative management with a pessary\n* Primary indication for use of pessary is treatment of pelvic organ prolapse\n\nExclusion Criteria:\n\n* Primary indication for pessary use is for management of stress urinary incontinence\n* Prior mesh-augmented prolapse repair (i.e. transvaginal mesh, sacrocolpopexy)\n* Short vaginal length (TVL \\\u003C 8cm) or subjective vaginal narrowing\n* Vaginal fistula (e.g. rectovaginal, vesicovaginal or any type of fistula involving the vagina)\n* Vaginal, rectal or bladder malignancy\n* Genitourinary infection requiring treatment (See below 1)\n* Ongoing treatment for vaginal infections (e.g., chronic bacterial vaginosis) (See below 2)\n* Inflammatory bowel disease (Crohn's or ulcerative colitis)\n* Pelvic or anorectal chronic pain\n* Pelvic floor surgery within the past 6 months or planning to undergo pelvic floor surgery\n* Congenital malformation of the bladder, rectum or vagina\n* Pregnant or planning pregnancy in the next 6 months\n* Prior failure of pessary for POP\n* History of hydroureter, hydronephrosis, or impaired renal function secondary to prolapse\n\n  1. Patients with acute vaginal infections will be eligible for enrollment 2 weeks after completing treatment with resolution of symptoms\n  2. OK to be on prophylactic\u002Fsuppressive therapy for HSV","FEMALE","18 Years",{"count":20,"type":21},218,"ESTIMATED","INTERVENTIONAL",[24],"NA","This multi-centered, randomized controlled trial will evaluate the safety and efficacy of home use of the novel Reia System (RS), which includes the Reia pessary and applicator, compared to standard pessary care (Gellhorn or ring with\u002Fwithout support without knob) among women with stage II-IV pelvic organ prolapse (POP). A total of 200 participants will be recruited among pessary naïve patients who are symptomatic and choose a vaginal pessary for management of their POP from study sites specializing in Urogynecology and Reconstructive Pelvic Surgery (URPS). Participants will be assigned via 1:1 randomization using computer generated numbers in permutated groups of variable block sizes to either the intervention (the Reia System, RS) or standard pessary care (SPC) stratified by site. Participation in this trial will involve a total of four visits over six months. The primary outcome measure will be satisfaction measured at the six-month time point. Secondary outcomes will include validated surveys to assess quality of life, number of self-management events, ease\u002Fdifficulty of pessary insertion\u002Fremoval, importance of ability to self-manage pessary, and adverse events.\n\nSpecific Aims\n\nAim 1: To compare satisfaction with pessary use and management between subjects randomized to the Reia System and those randomized to standard of care pessary.\n\nAim 2: To assess successful fitting, number of refitting visits, number of self-management events and continued pessary use over a 6-month period between subjects randomized to the Reia System and those randomized to standard of care pessary.\n\nAim 3: To compare ease\u002Fdifficulty of pessary use and importance of ability to self-manage, as well as quality of life over a 6-month period between subjects randomized to the Reia System and those randomized to standard of care pessary.\n\nAim 4: To measure rates of adverse events and risk factors for adverse events over a 6-month period between subjects randomized to the Reia System and those randomized to standard of care pessary.",[27,28],"Pelvic Organ Prolapse","Prolapse","RECRUITING","2026-04-08",{"date":32,"type":33},"2026-04-13","ACTUAL",{"date":35,"type":33},"2024-11-01",{"date":37,"type":21},"2026-10-30",{"name":39,"class":40},"Medstar Health Research Institute","OTHER",9,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":50,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":54,"conditions":55,"keywords":66,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":81},"100549201","biological-ovitex-versus-synthetic-graft-in-robotic-prolapse-surgery-100549201","NCT06430931","Biological OviTex Versus Synthetic Graft in Robotic Prolapse Surgery","Biological OviTex Versus Synthetic Graft in Robotic Prolapse Surgery: a Multicentre, Phase 11-111, Partially Randomised Patient Preference Trial","ProTex","Inclusion Criteria:\n\n* Indication for VMR or SCR set by the treating surgeon\u002Fgynecologist in accordance to the current guidelines on rectal and pelvic prolapse;\n* Counselled for therapeutic options and given informed consent for VMR or SCR;\n* Counselled for different types of mesh (OviTex or Prolene) and randomisation;\n* Written informed consent for randomisation, OviTex implant or Prolene;\n* Written informed consent for observational data collection.\n\nExclusion Criteria:\n\n* Mentally incompetent patients (unable to fulfil questionnaires).\n* Allergy to ovine rumen.\n* A medical history of pelvic radiation therapy.\n* Scheduled for a redo-rectopexy.\n* A medical history of previously implanted pelvic floor meshes or native tissue.\n* Language barrier","ALL",{"count":52,"type":21},184,[24],"This prospective study aims to assess the efficacy of the OviTex 1S permanent mesh in pelvic floor surgery in comparison with the current standard polypropylene mesh.",[56,28,57,58,59,60,61,62,63,64,65],"Colorectal Disorders","Prolapse Rectal","Prolapse Genital","Prolapse Pelvic","Rectocele","Prolapse Uterus","Cystocele","Enterocele","Prolapse Bladder","Prolapse; Cervix",[28,67,68,69,70,71],"Abdominal prolapse Surgery","Biological mesh","OviTex","VMR","sacrocolporectopexy","2025-12-31",{"date":74,"type":33},"2026-01-02",{"date":76,"type":33},"2023-12-06",{"date":78,"type":21},"2027-07-01",{"name":80,"class":40},"Meander Medical Center",1,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":89,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":22,"phases":92,"briefSummary":93,"conditions":94,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":81},"100568315","a-telehealth-intervention-to-increase-patient-preparedness-for-surgery-in-latinas-100568315","NCT06679621","A Telehealth Intervention to Increase Patient Preparedness for Surgery in Latinas","TIPPS-Urogyn","Inclusion Criteria:\n\nPatients who\n\n* Self-report as female\n* 18 years and older\n* Self-report as Hispanic ethnicity\n* Scheduled to undergo a surgery for a urogynecologic condition in the operating room (surgery to correct pelvic organ prolapse, urinary\u002Ffecal incontinence, fistula, urethral masses)\n* Able to read and write English and\u002For Spanish\n\nUrogynecologists who -Routinely perform urogynecologist surgeries to correct pelvic organ prolapse, urinary\u002Ffecal incontinence, fistula, urethral masses\n\nNurses who\n\n* Spend most of their time at a urogynecologic clinic\n* Engage in the process of preparing patients for urogynecologic surgery\n\nExclusion Criteria:\n\nPatients who\n\n* Self-report as male\n* Are less than 18 years of age\n* Self-report as not of Hispanic ethnicity\n* Scheduled to undergo a surgery for a condition that is not urogynecologic or is not in the operating room\n* Patients undergoing procedures that are traditionally performed in the office (bladder Botox, pelvic floor Botox, urethral bulking)\n\nUrogynecologists who\n\n-Do not routinely perform urogynecologic surgery\n\nNurses who\n\n* Do not spend most of their time at a urogynecology clinic\n* Do not engage in the process of preparing patients for urogynecologic surgery",true,{"count":91,"type":21},357,[24],"There are 3 aims of this study. In Aim 1 community patient partners will be enrolled to help guide the research being performed in all of the aims. Investigators will also administer a survey that will help determine factors associated with surgical preparedness. In Aim 2 investigators will develop an intervention to increase surgical preparedness using Human Centered Design Methods. Aim 3 will pilot test the intervention using mixed methods to determine feasibility and implementation outcomes.",[95,28],"Incontinence","2025-07-21",{"date":98,"type":33},"2025-07-24",{"date":100,"type":33},"2024-11-11",{"date":102,"type":21},"2027-06-01",{"name":104,"class":40},"University of Alabama at Birmingham"]