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Prolapse clinical trials

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NCT ID: NCT04880239 Recruiting - Prolapse; Female Clinical Trials

REDUCE Trial- Reducing Prolapse Recurrence

Start date: November 23, 2021
Phase: N/A
Study type: Interventional

This study will examine whether surgeons should add a prophylactic posterior colpoperineorrhaphy to a mesh-augmented apical prolapse repair.

NCT ID: NCT04858438 Recruiting - Clinical trials for Pelvic Organ Prolapse

Pain After Insufflation for Robotic Sacrocolpopexy (PAIRS) Trial

Start date: April 2, 2021
Phase: N/A
Study type: Interventional

This study evaluates post-operative pain between different insufflation pressures during robotic-assisted sacrocolpopexy. Subjective pain and narcotic usage after surgery will be measured.

NCT ID: NCT04852731 Recruiting - Clinical trials for Mitral Valve Prolapse

STretch and Myocardial Characterization in Arrythmogenic Mitral Valve Prolapse-2

STAMP-2
Start date: August 30, 2021
Phase: N/A
Study type: Interventional

Mitral valve prolapse (MVP) is a frequent affection of the mitral valve with a prevalence of 2-3% in the general population. This valvular disease is generally considered as benign, but may at term evolve toward mitral valve regurgitation of various severity and/or arrhythmia. Mitral valve prolapse is routinely diagnosed using transthoracic echocardiography. Subsequent examinations (24-hour external loop recording, exercise electrocardiogram, cardiac Magnetic Resonance Imaging) and a close follow-up can be proposed to the patient depending on its condition. More recently, detection of myocardial fibrosis and a mitral ring disjunction among patients with MVP were associated with the occurrence of severe ventricular arrhythmia. The investigators hypothesize that ventricular remodeling over time is mediated by the progression of mitral insufficiency severity from myocardial fibrosis secondary to MVP and possibly promoted by other mitral valve abnormalities. This remodeling, characterized by circulating biomarkers and imaging (MRI and echocardiography), could allow the identification of patients with a higher risk of severe ventricular arrhythmia. The main objective of this study is to identify prognostic factors for unfavorable evolution (ventricular remodeling or a rhythm disorder event) at 3 years from initial assessments in MVP patients.

NCT ID: NCT04850365 Recruiting - Clinical trials for Pelvic Organ Prolapse

Abdominal Sacral Hysteropexy Versus Vaginal Sacrospinous Hysteropexy

Start date: January 1, 2020
Phase: N/A
Study type: Interventional

The aim of the current study is to compare abdominal sacral cervicopexy with vaginal sacrospinous cervicopexy in women with apical prolapse in terms of operative time, procedures safety and efficacy.

NCT ID: NCT04829175 Recruiting - Clinical trials for Pelvic Organ Prolapse

Ethicon Pelvic Mesh Post Market Clinical Follow-up Registry

Start date: April 13, 2022
Phase:
Study type: Observational

The objective of this post market, clinical registry is to evaluate the performance of the products of the TVT family of products or vaginal vault or uterine prolapse repair (with laparotomic or laparoscopic approach including robotic assisted) using either Gynemesh PS Mesh or Artisyn Mesh in women undergoing surgery for SUI and POP.

NCT ID: NCT04829058 Recruiting - Clinical trials for Pelvic Organ Prolapse

GYNEMESH PS Mesh Post Marketing Clinical Follow-Up Study

Start date: November 24, 2021
Phase:
Study type: Observational

The objective of this retrospective and prospective, single-arm, observational, multicenter, post-market study is to evaluate outcomes in women who underwent surgery for vaginal or uterine prolapse with a GYNEMESH PS Mesh.

NCT ID: NCT04817150 Recruiting - Rectal Prolapse Clinical Trials

3D vs 2D-laparoscopy for Rectocele and Rectal Prolapse Correction: a Prospective, Randomized, Single Center Study

LARC
Start date: March 10, 2021
Phase: N/A
Study type: Interventional

The aim is to compare proximate and remote results of 3D and conventional 2D laparoscopic interventions in terms of efficacy and safety in treatment of symptomatic rectocele and rectal prolapse. This is a prospective randomized comparative study in parallel groups conducted in single Colorectal unit. Inclusion criteria: female patients with stage 3 rectocele (3-4 POP-Q [pelvic organ prolapse quantification] grade) and/or full-thickness rectal prolapse. Intervention - laparoscopic ventral rectopexy. The primary outcome is objective cure rate of pelvic prolapse. Secondary outcomes include obstructive defecation and incontinence symptoms according to Wexner and Cleveland Clinic scales, and satisfaction according to Patient Global Impression of Improvement questionnaire. Operative times, intraoperative blood loss, length of hospital stay, postop pain severity, urinary incontinence, as well as surgical and mesh complications are also assessed. The specific point of interest in this study is surgeon's tiredness after the operation assessed with Profile of Mood States questionnaire.

NCT ID: NCT04807920 Recruiting - Clinical trials for Pelvic Organ Prolapse

BOTOX® at the Time of Prolapse Surgery for OAB

Start date: September 23, 2021
Phase: Phase 4
Study type: Interventional

The purpose of the study will be to assess the efficacy and safety of bladder BOTOX® for overactive bladder symptoms, such as urinary urgency and frequency, given at the time of prolapse surgery.

NCT ID: NCT04733560 Recruiting - Clinical trials for Pelvic Organ Prolapse

Preoperative Analgesia by Infiltration of the Pudendal Nerve Prior to Sacrospinous Ligament Suspension

PAINS
Start date: April 1, 2021
Phase: N/A
Study type: Interventional

Pelvic organ prolapse is a common problem. It affects about half of women and causes uncomfortable bulge sensations (similar to sitting on a ball), urine and stool problems, difficulty with sexual activity and embarrassment. Almost one of every five women undergoes surgery to treat prolapse.Typically, vaginal surgery is done while patients are asleep and local anesthetic- freezing medication- is injected where incisions are made to minimize the pain from surgery when waking up. Pudendal blocks are nerve blocks where local anesthetic is used to freeze a nerve that supplies sensation to the vulva and vaginal area. It is traditionally used to help with pain for women giving birth, but hasn't been studied well in women undergoing vaginal surgery for prolapse. The investigators believe that by using a small amount of freezing to provide a pudendal block at the time of surgery, on top of the freezing typically provided, that there will be minimized pain after surgery and improve the recovery process. Based on previous studies using pudendal blocks for different vulvar and vaginal procedures, the investigators believe this to be a safe and potentially beneficial practice. The investigators are planning to conduct a randomized controlled trial of 50 women. 25 will receive pudendal nerve blocks at the time of surgery, and 25 will receive placebo injections.The investigators will monitor their pain scores, satisfaction, use of pain medications and return to activities in order to determine if our intervention has caused a significant improvement in recovery.

NCT ID: NCT04701047 Recruiting - Vaginal Prolapse Clinical Trials

Prospective Observational Prolapse Study

Start date: September 3, 2021
Phase:
Study type: Observational [Patient Registry]

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.