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Prolapse clinical trials

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NCT ID: NCT05715489 Recruiting - Clinical trials for Pelvic Organ Prolapse

Pectopexy Surgery Without Mesh

Start date: May 11, 2022
Phase: N/A
Study type: Interventional

it is aimed to examine the effect of laparoscopic pectopexy surgery without mesh on Pelvic Organ Prolapse Measurement (POP-Q) and quality of life of the patient.

NCT ID: NCT05713422 Recruiting - Clinical trials for Pelvic Organ Prolapse

Superiority of Perineoplasty as Concomitant Surgical Procedure During Pelvic Organ Prolapse Repair

SUPPORT
Start date: April 23, 2023
Phase:
Study type: Observational [Patient Registry]

The goal of this study is to evaluate whether adding perineoplasty is, in comparison to performing vaginal prolapse surgery without adding perineoplasty, superior with respect to efficacy and cost-effectiveness and non-inferior with respect to morbidity, in patients undergoing vaginal surgical correction of pelvic organ prolapse at 24 months after surgery.

NCT ID: NCT05688059 Recruiting - Clinical trials for Pelvic Organ Prolapse

Absorbable Suture vs Permanent Suture in Sacrospinous Ligament Suspension

Start date: January 6, 2023
Phase: N/A
Study type: Interventional

Sacrospinous ligament suspension (SSLS) was first described in 1958. It is commonly performed for correction of apical prolapse. A combination of delayed absorbable and/or permanent sutures are commonly used for the procedure. When permanent sutures are used, risk of suture-related complications is present and patients may require suture removal. In available literature, there is limited data comparing the efficacy and suture-related complications when using different types of sutures. A previous randomized controlled trial demonstrated that using an absorbable suture is equally efficacious as delayed absorbable sutures in SSLS. However, there is no comparison to absorbable versus permanent suture. Our aim is to compare the absorbable suture versus permanent suture for treating pelvic organ prolapse and to compare suture-related complications. Our primary outcome is comparing POPQ point C at 12 month follow up for absorbable vs permanent suture. Participants will be randomized 1:1 to absorbable or permanent suture. Follow up will occur at 2-4 weeks, 12 weeks and 12 months after the surgery.

NCT ID: NCT05682989 Recruiting - Clinical trials for Pelvic Organ Prolapse

Efficacy/Safety of Urogynecology Synthetic Mesh Surgery

Start date: August 1, 2022
Phase:
Study type: Observational

This is a retrospective cohort study, aiming at analyzing the efficacy and safety of mesh surgery in pelvic organ prolapse. The synthetic mesh for pelvic organ prolapse include transvaginal mesh or laparotomy, laparoscope, or robotic-assisted laparoscopic sacrocolpopexy with mesh augmentation. The investigators would like to evaluate the efficacy and safety, such as recurrence rates and complication rates for women who underwent urogynecology mesh surgery.

NCT ID: NCT05633901 Recruiting - Prolapse; Female Clinical Trials

Impact of Preop Video on Patient Anxiety

Start date: December 7, 2022
Phase: N/A
Study type: Interventional

To determine whether a pre-operative educational video has an impact on the anxiety of patients undergoing vaginal prolapse surgery

NCT ID: NCT05631730 Recruiting - Clinical trials for Mitral Valve Prolapse

Effect and Safety of Flecainide and Metoprolol Versus Metoprolol Alone to Suppress Ventricular Arrhythmias in Arrhythmic Mitral Valve Prolapse

FLECAPRO
Start date: January 4, 2023
Phase: Phase 3
Study type: Interventional

FLECAPRO is a randomized controlled crossover trial assessing the effect and safety of adding flecainide to standard beta-blocker therapy to reduce the burden of ventricular arrhythmias in patients with arrhythmic mitral valve prolapse. The primary endpoint of will be assessed using an implantable loop recorder with blinded endpoint adjudication.

NCT ID: NCT05628831 Recruiting - Clinical trials for Vaginal Vault Prolapse

Traditional Vaginal Surgery VS Autologous Tissue in Pelvic Floor Repair

PREFAP
Start date: March 18, 2023
Phase: N/A
Study type: Interventional

The goal of this randomized, non blind, one center study is to compare the efficacy of vNOTES (vaginal natural orifice transluminal surgery) and traditional vaginal operation between the two groups by determining the risk of re-operation for anterior, posterior or apical prolapse within the study period. Participants with a POP-Q (Pelvic Organ Prolapse Quantification) of 3 or 4 and an indication for hysterectomy and prolapse repair will be selected and randomly divided in two groups. One group will be operated with standard technique for pelvic organ prolapse and in the other autologous graft will be used using vNOTES ICIQ-LUTSqol (International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life Module) and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire IUGA revised (PISQ-IR) will be used as a subjective measurement of operative treatment. Objective evaluation of the effect of postoperative results will be done using transperineal ultrasound before operation, 6 and 12 months after procedure. EXPECTED CONTRIBUTION: In this research we will evaluate the feasibility and surgical outcome of vaginal NOTES (vNOTES) prolapse repair using posterior rectus fascia (PREFAP- Posterior Rectus Fascia Prolapse repair)

NCT ID: NCT05602246 Recruiting - Clinical trials for Pelvic Organ Prolapse

Study Comparing Transobturator Cystocele vs. Anterior Vaginal RepairS

STARS
Start date: December 1, 2022
Phase: N/A
Study type: Interventional

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/or 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.

NCT ID: NCT05586984 Recruiting - Clinical trials for Pelvic Organ Prolapse

Transvaginal Sacrospinous Hysteropexy Versus Laparoscopic Uterine Lateral Suspension

Start date: July 26, 2022
Phase:
Study type: Observational

Transvaginal or transabdominal surgeries are current choices of uterus-preserving surgeries for pelvic organ prolapse. Laparoscopic lateral uterine suspension, a modified surgical approach of uterine suspension from bilateral abdominal wall fascia, performed with expected safety and simplicity of surgery besides advantages including small wound incision and fast recovery in laparoscopic surgeries. This trial aim to discuss the therapeutic efficacy, long term safety, and adverse events of laparoscopic lateral uterine suspension and compare with the conventional transvaginal sacrospinous ligament fixation with native tissue repair.

NCT ID: NCT05562804 Recruiting - Cardiac Arrhythmia Clinical Trials

Mitral Valve Prolapse, Arrhythmias and Mitral Valve Surgery

MVP-A&S
Start date: February 10, 2021
Phase:
Study type: Observational [Patient Registry]

Mitral valve prolapse (MVP) is associated with malignant ventricular arrhythmias (VA) and sudden cardiac death. A proper electrophysiological and echocardiographic characterization of this population is missing. Moreover, the effects of mitral valve repair on the arrhythmic burden are still matter of debate. The investigators sought to explore the role of the arrhythmic substrate in the risk stratification of patients with MVP and to assess whether mitral surgery is followed by a significant modification of the baseline arrhythmic pattern.