[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cystocele\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cystocele":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,49,81],{"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":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100634821","poly-l-lactic-acid-for-vulvovaginal-tissue-regeneration-100634821",false,"NCT07544667","Poly-L-Lactic Acid for Vulvovaginal Tissue Regeneration","Intravaginal Injection of Poly-L-Lactic Acid for Treatment of Cystocele: A Randomized Trial","Inclusion Criteria:\n\n* Age \\> 21\n* Stage II POP of anterior vaginal wall (Ba ≥ -1)\n* Symptomatic bulge symptoms\n\n  * Positive response to PFDI-20 question 3: Do you usually have a bulge or something falling out that you can see or feel in the vaginal area?\n  * AND any degree of bother. Providing any answer other than \"not at all\" to \"how much does this bother you\"\n* Abstinent, on contraception, or postmenopausal at time of injection\n* Must read or understand English\n\nExclusion Criteria:\n\n* Concurrent apical or posterior prolapse \\> stage 1\n* Prior pelvic radiation\n* Previous vaginal reconstructive surgery (Except total vaginal hysterectomy or sling)\n* History of chronic vaginal infections (ex. Sexually transmitted infection or bacterial vaginosis)\n* Prior vaginal laser treatment \\\u003C 6 months\n* Planned vaginal laser\u002Ftopical treatment\n* History of hypertrophic reaction to vicryl (polyglactin-910)\n* Allergy to Sculptra aesthetic or any components of Sculptra (PLLA, carboxymethylcellulose, non-pyrogenic mannitol)\n* Allergy to silicone\n* Premenopausal without contraception or abstinence during treatment phase\n* Currently breastfeeding\n* Connective tissue disorder\n* Uncontrolled diabetes (defined as HbA1c \\> 8)\n* Does not read or understand English\n* Inability to provide informed consent\n* Physical limitations that would prevent subjects from performing the required pelvic wand massage sessions after each injection, such as significant arthritis or other mobility limitations.\n* Prescription anticoagulation therapy that cannot be safely discontinued (Aspirin and anti-platelet therapies would be considered acceptable)\n* Current use of other treatments for prolapse, such as pessary, in subjects who are unwilling to discontinue these treatments during the study period.\n* Planning to start pelvic floor physical therapy during the study\n* Undergoing physical therapy and not willing to stop internal therapy for 2 weeks after an injection or biopsy","FEMALE","21 Years",{"count":19,"type":20},20,"ESTIMATED","INTERVENTIONAL",[23],"NA","Pelvic organ prolapse (POP) is a condition characterized by descent of vaginal walls, uterus and cervix, or the perineum and causes a sensation of vaginal bulge and pelvic pressure. Millions of women in the United States are affected, and the number is expected to rise significantly in the coming decades. Current treatments either involve conservative measures or surgery. Surgery may lead to changes in vaginal topography and scar tissue, both of which impact sexual function. There are no treatment options that restore vaginal tissue strength and preserve, even optimize, sensation and blood flow to the vagina. This project will evaluate the use of poly-L-lactic acid (PLLA), an FDA-approved biostimulant for dermatologic use with an expansive safety profile over the past decade, in the treatment of anterior wall POP and its impact on sexual function. Our study will compare intravaginal injection of PLLA vs. placebo in women with stage 2 cystocele and investigate safety and preliminary efficacy of PLLA. Prior study of regenerative biologics for the vulva and vagina have shown great promise, but use of these has not been explored for POP. This randomized controlled trial has the potential to shift the paradigm of prolapse management from surgical reconstruction to regeneration. This shift will prevent the risks of surgery and has the potential to improve sexual function and quality of life by resolving POP.",[26,27,28],"Pelvic Organ Prolapse (POP)","Cystocele","Pelvic Floor Disorder",[30,31,32,33,34,35],"regenerative medicine","biostimulant","tissue regeneration","pelvic floor disorder","pelvic organ prolapse","cystocele","NOT_YET_RECRUITING","2026-06-02",{"date":39,"type":40},"2026-06-04","ACTUAL",{"date":42,"type":20},"2026-07",{"date":44,"type":20},"2028-06",{"name":46,"class":47},"Cassandra Kisby","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":21,"phases":59,"briefSummary":60,"conditions":61,"keywords":64,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":80},"100485528","study-comparing-transobturator-cystocele-vs-anterior-vaginal-repairs-100485528","NCT05602246","Study Comparing Transobturator Cystocele vs. Anterior Vaginal RepairS","STARS","Inclusion Criteria:\n\n* (at least) 2nd stage prolapse of the anterior compartment (Ba ≥ -1)\n* Age ≥ 50 years\n* Symptom bulge\n* Ability to speak Czech or English\n\nExclusion Criteria:\n\n* Malignancy","50 Years",{"count":58,"type":20},592,[23],"Surgical correction of the prolapse in the anterior compartment remains one of the major challenges in urogynecology. Paravaginal defect in level II of vaginal fixation results in the majority of cystoceles. Clinically, these defects are often combined and\u002For may be bilateral. Hence, careful assessment and individualized planning of the surgical procedure is essential to optimize cystocele repair outcome. Several surgical techniques and approaches have been used for cystocele repair. After the ban on transvaginal meshes, the interest in native tissue repair has risen. Paravaginal defect repair is an effective surgery for paravaginal defect reconstruction. There is a current trend to utilize transvaginal surgery instead of more invasive transabdominal surgery. A novel method of transvaginal paravaginal defect repair - TOCR (transobturator cystocele repair) was suggested. The principle objective of the present trial is to compare its efficacy and safety to preexisting method of native tissue cystocele repair.",[62,27,63],"Pelvic Organ Prolapse","Cystocele and Incomplete Uterovaginal Prolapse",[65,66,67,68,69],"Pelvic organ prolapse","Quality of life","TOCR","Anterior vaginal wall repair","Transobturator cystocele repair","RECRUITING","2026-03-18",{"date":73,"type":40},"2026-03-19",{"date":75,"type":40},"2022-12-01",{"date":77,"type":20},"2034-11-01",{"name":79,"class":47},"Charles University, Czech Republic",8,{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":89,"minAge":90,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":21,"phases":93,"briefSummary":94,"conditions":95,"keywords":106,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":48},"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","18 Years",{"count":92,"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.",[96,97,98,99,100,101,102,27,103,104,105],"Colorectal Disorders","Prolapse","Prolapse Rectal","Prolapse Genital","Prolapse Pelvic","Rectocele","Prolapse Uterus","Enterocele","Prolapse Bladder","Prolapse; Cervix",[97,107,108,109,110,111],"Abdominal prolapse Surgery","Biological mesh","OviTex","VMR","sacrocolporectopexy","2025-12-31",{"date":114,"type":40},"2026-01-02",{"date":116,"type":40},"2023-12-06",{"date":118,"type":20},"2027-07-01",{"name":120,"class":47},"Meander Medical Center"]