[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"prolapse-genital\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:prolapse-genital":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,47,87,111],{"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":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100637156","postoperative-vaginal-compression-after-prolapse-surgery---an-rct-100637156",false,"NCT07612202","Postoperative Vaginal Compression After Prolapse Surgery - an RCT","A Randomized Controlled Trial on Postoperative Vaginal Compression After Prolapse Surgery","Inclusion criteria:\n\n* Planned anterior colporrhaphy, posterior colporrhaphy, or cervical amputation at the day surgery department, Nordsjællands Hospital, Capital Region, Denmark\n* Age 18 years and older\n\n  . Cognitively capable patient\n* Received information material as described in the protocol\n\nExclusion criteria:\n\n* Failure to pause blood-thinning medication on the day of surgery, if this was planned\n* Failure to discontinue regular intake of fish oil or ginger extract four weeks prior to the procedure\n* Immunosuppressed patients\n* Planned perineorrhaphy\n* Surgery involving more than two compartments\n* Non-Danish speaking patients","FEMALE","18 Years",{"count":19,"type":20},360,"ESTIMATED","INTERVENTIONAL",[23],"NA","The goal of this clinical trial is to learn if omitting postoperative vaginal compression (packing) can facilitate a more efficient recovery after elective surgery for uterovaginal prolapse. The main questions it aims to answer are: Will the omission of vaginal compression result in a non-inferior (unchanged) rate of prolapse recurrence within the first three months after surgery? Does the omission of vaginal compression lead to a shorter hospital stay and a faster return of normal bladder function? Researchers will compare a group that receives no postoperative vaginal compression to a control group that receives standard vaginal gauze packing for two hours to see if skipping the packing leads to shorter hospital stays and faster bladder emptying without increasing the risk of the prolapse returning.",[26,27,28],"Postoperative Care","Prolapse Genital","Urogynecologic Surgery",[30,31,32,33],"postoperative","randomised ccontrolled trial","vaginal compression","prolapse surgery","NOT_YET_RECRUITING","2026-05-21",{"date":37,"type":38},"2026-05-28","ACTUAL",{"date":40,"type":20},"2026-06-03",{"date":42,"type":20},"2028-12",{"name":44,"class":45},"Christiane Marie Bourgin Folke Gam","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":55,"minAge":17,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":21,"phases":58,"briefSummary":59,"conditions":60,"keywords":71,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":46},"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":57,"type":20},184,[23],"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.",[61,62,63,27,64,65,66,67,68,69,70],"Colorectal Disorders","Prolapse","Prolapse Rectal","Prolapse Pelvic","Rectocele","Prolapse Uterus","Cystocele","Enterocele","Prolapse Bladder","Prolapse; Cervix",[62,72,73,74,75,76],"Abdominal prolapse Surgery","Biological mesh","OviTex","VMR","sacrocolporectopexy","RECRUITING","2025-12-31",{"date":80,"type":38},"2026-01-02",{"date":82,"type":38},"2023-12-06",{"date":84,"type":20},"2027-07-01",{"name":86,"class":45},"Meander Medical Center",{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":95,"enrollmentInfo":96,"targetDuration":4,"studyType":21,"phases":98,"briefSummary":99,"conditions":100,"keywords":4,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":46},"100611841","randomized-study-evaluating-the-treatment-of-vulvovaginal-gaping-by-plication-of-the-puborectalis-muscles-versus-perineorrhaphy--transverse-myorrhaphy-of-the-puborectalis-muscles-at-12-months-hera-100611841","NCT07245823","Randomized Study Evaluating the Treatment of Vulvovaginal Gaping by Plication of the Puborectalis Muscles Versus Perineorrhaphy ± Transverse Myorrhaphy of the Puborectalis Muscles at 12 Months. (HERA)","Randomized Study Evaluating the Treatment of Vulvovaginal Gaping by Plication of the Puborectalis Muscles Versus Perineorrhaphy ± Transverse Myorrhaphy of the Puborectalis Muscles at 12 Months.","HERA","Inclusion Criteria:\n\n* Female patient between 18 and 80 years-old.\n* Genital hiatus at rest ≥ 4 cm by POP-Q\n* Sexually active woman without pain (never\u002Frarely scored) during penetration and who has stopped sexual activity due to vulvovaginal incompetence without pain (never\u002Frarely scored) during penetration\n* Prolapse\n* Candidate for surgery for anatomical reconstruction of the vulvovaginal incompetence\n* Patient affiliated with a social security scheme or beneficiary of such a scheme, according to Article L.1124-1 of the Public Health Code\n* Free, informed and signed consent\n\nExclusion Criteria:\n\n* Resting GH \\\u003C 4 cm (POP-Q classification)\n* Women not sexually active and not planning to become sexually active\n* Chronic perineal pain syndrome\n* Anal sphincter injury with concomitant indication for sphincterorrhaphy\n* Cognitive or language impairment of the patient unable to complete the study questionnaires\n* Contraindications to surgery or anesthesia\n* Adult under guardianship, curatorship, or other legal protection, deprived of liberty by judicial or administrative decision, hospitalized without consent\n* Pregnant, breastfeeding, or parturient woman\n* Patient planning to become pregnant during the study period\n* Immediate postpartum","80 Years",{"count":97,"type":20},100,[23],"Vulvovaginal incompetence is generally associated with prolapse and contributes to the pathogenesis of the latter. The perineum and the perineal body (PB) are structures frequently injured throughout life, leading to vesicourethral and rectoanal dysfunction, which are the main focus of study. Other symptoms, such as periorificial dyspareunia and vulvovaginal incompetence, appear to be less verbalized by women. The resulting sexual discomfort is linked, on the one hand, to physical anatomical trauma, with, in some cases, vulvovaginal incompetence contributing to a vaginal sensitivity decreased, and, on the other hand, to psychological trauma with damage to self-image. Vulvoperineoplasty is a surgical repair procedure that aims to optimally reconstruct the introital anatomy by correcting the vulvovaginal incompetence in order to restore normal anatomy, restore self-image, and treat the symptoms of vaginal laxity (feeling of a vagina that is too large and loss of vaginal sensitivity).\n\nConventional surgical techniques for treating vulvar incompetence, such as levator myorrhaphy and perineorrhaphy, are currently being questioned because they cause functional sequelae, particularly regarding to sexual quality of life. The pubo-rectal muscle plication (PPR) technique is based on the anatomical observation of puborectalis muscle lengthening (PMR) observed on MRI scans in patients with vaginal incompetence. This technique could be an interesting alternative in the surgical treatment of vulvovaginal incompetence.\n\nThe main objective of this study is to evaluate the effectiveness of anatomical reconstruction of vulvovaginal incompetence by sagittal plication of the puborectalis muscles vs. by perineorrhaphy ± transverse myorrhaphy of the puborectalis muscles at 12 months.",[27,101],"Vulvovaginal Disease","2025-11-17",{"date":104,"type":38},"2025-11-24",{"date":106,"type":20},"2025-11-20",{"date":108,"type":20},"2029-04-25",{"name":110,"class":45},"Ramsay Générale de Santé",{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":4,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":118,"enrollmentInfo":119,"targetDuration":4,"studyType":21,"phases":121,"briefSummary":123,"conditions":124,"keywords":4,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":46},"100547204","phase-2-transvaginal-human-acellular-dermal-matrix-for-prolapse-treatment-100547204","NCT06404931","Transvaginal Human Acellular Dermal Matrix for Prolapse Treatment","Transvaginal Human Acellular Dermal Matrix and Sacrospinous Fixation for Anterior and Apical Prolapse Treatment in Patients With Hiatal Ballooning or Levator Ani Injury: a Randomized Pilot Trial","Inclusion Criteria:\n\n* Women with symptomatic POP with indication of vaginal surgery.\n* Women with hiatal ballooning or levator ani injury evaluated by 3D pelvic floor ultrasound.\n* Women ≥18 years old.\n* Women wishing to complete a 36-month follow-up.\n* Understand and accept the study procedures and sign the informed consent.\n\nExclusion Criteria:\n\n* Women with previous pelvic floor or prolapse surgery\n* Women with POP grade IV\n* Women with chronic pelvic pain.\n* Not being able to understand the nature of the study and\u002For the procedures to be followed.\n* Not signing the informed consent","100 Years",{"count":120,"type":20},90,[122],"PHASE2","This is a randomised study in which we compare the effectiveness of three different procedures in mending symptomatic anterior and apical prolapse in patients who are candidates to receive surgery.\n\nThey will be randomly assigned in a ratio 1:1:1 to three different groups who will have assigned three different kinds of surgery. In the patients of the first group a classic vaginal hysterectomy with anterior colporrhaphy will be practised. Patients who belong to group two will undergo a vaginal hysterectomy followed by placement of an acellular dermal matrix from cadaveric donors (hADM) for anterior reinforcement and sacrospinous fixation with Anchorsure® device (Neomedic trade mark (TM) International, Spain). Finally, patients from group three will have vaginal hysterectomy followed by sacrospinous fixation with Anchorsure® alone .\n\nPatients will be followed-up at 4 weeks, 6 months, 12 months and annually till 36 months to evaluate relapses and possible complications.",[125,27,126],"Prolapse; Female","Prolapse Uterovaginal","2025-01-15",{"date":129,"type":38},"2025-01-17",{"date":131,"type":38},"2024-07-01",{"date":133,"type":20},"2026-01-01",{"name":135,"class":45},"Hospital Mutua de Terrassa"]