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Vaginal Vault Prolapse clinical trials

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NCT ID: NCT05960292 Recruiting - Clinical trials for Vaginal Vault Prolapse

Laparoscopic Versus Vaginal Approach Closure Complications

Start date: August 1, 2023
Phase: N/A
Study type: Interventional

Hysterectomy is considered as a common operation in Gynecology. Hysterectomy could be made by vaginally, laparoscopically or abdominally. The American Congress of Obstetricians and Gynecologist advises the use of a minimally invasive technique for the sake of women and to decrease hospital stay and costs.

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: 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: NCT04172896 Recruiting - Clinical trials for Vaginal Vault Prolapse

Intraperitoneal and Extraperitoneal Uterosacral Ligament Suspensions for Post-Hysterectomy Vaginal Vault Prolapse

Start date: November 1, 2019
Phase: N/A
Study type: Interventional

Post-hysterectomy vaginal vault prolapse is a common pelvic floor disorder described as descent of the vaginal apex after hysterectomy. The incidence of post-hysterectomy vault prolapse has been reported to follow 11.6% of hysterectomies performed for prolapse and 1.8% for other benign diseases. The majority of surgical repairs to correct post-hysterectomy vault prolapse are approached via a transvaginal route. A common transvaginal procedure to correct vaginal vault prolapse is the uterosacral ligament suspension. Traditionally, the uterosacral ligaments have been accessed intraperitoneally to perform the vaginal suspension. More recently, an extraperitoneal approach has been utilized with good results. There is limited evidence comparing the the two approaches. Thus, the objectives of this study are to compare compare operative time, hospital stay, cost, surgical success, and other perioperative outcomes between the two approaches.

NCT ID: NCT04038099 Completed - Clinical trials for Urinary Incontinence

Lessons on Urethral Lidocaine in Urodynamics

LULU
Start date: August 14, 2019
Phase: Phase 4
Study type: Interventional

This trial will assess whether use of intraurethral 2% lidocaine jelly meaningfully impacts sensation during filling (i.e., a change of more than 25% of first sensation, first desire to void, strong desire to void, or maximum cystometric capacity) and determine whether the use of intraurethral 2% lidocaine jelly meaningfully impacts pain/discomfort, filling metrics, and voiding metrics.

NCT ID: NCT03714607 Active, not recruiting - Cystocele Clinical Trials

Laser Therapy in Managing Vaginal Prolapse

Start date: November 30, 2018
Phase: N/A
Study type: Interventional

Efficacy of laser therapy in postmenopausal women with symptomatic prolapse stage >1. Assessment tools will include prolapse stage quantification system (POP-Q) and validated condition related questionnaires.

NCT ID: NCT03681223 Completed - Clinical trials for Vaginal Vault Prolapse

Restorelle® Y Mesh vs. Vertessa® Lite Y Mesh for Laparoscopic and Robotic-assisted Laparoscopic Sacrocolpopexy

Lite-Y
Start date: September 18, 2018
Phase: N/A
Study type: Interventional

This is a randomized clinical trial to compare outcomes between the Restorelle® Y mesh and Vertessa® lite Y mesh for the treatment of vaginal vault prolapse. Hypothesis: Vertessa® lite Y mesh is not inferior to Restorelle® Y mesh for the treatment of vaginal vault prolapse

NCT ID: NCT02680145 Completed - Clinical trials for Pelvic Organ Prolapse

Prediction of Postsurgical Symptomatic Outcomes With Preoperative Pessary Use

Start date: March 11, 2016
Phase: N/A
Study type: Interventional

This is a single center, prospective trial of pessary use prior to reconstructive pelvic floor surgery for pelvic organ prolapse. The goal of the study is to evaluate the change in pelvic floor symptoms with pessary use and subsequent reconstructive surgery. Additionally, we will assess the impact that preoperative pessary use has on patient self-reported preparedness for surgery.

NCT ID: NCT02431897 Completed - Clinical trials for Pelvic Organ Prolapse

Investigation to Minimize Prolapse Recurrence of the Vagina Using Estrogen

IMPROVE
Start date: December 2016
Phase: Phase 4
Study type: Interventional

This study randomizes postmenopausal women with symptomatic pelvic organ prolapse planning native tissue transvaginal surgical repair to 6-8 weeks of preoperative and 1-year continued postoperative vaginal estrogen cream compared to placebo cream. This clinical trial and basic science investigation are designed to understand the mechanisms by which local estrogen treatment affects connective tissues of the pelvic floor and determine whether its use before and after prolapse repair will (i) improve success rates of the surgical intervention and minimize prolapse recurrence and (ii) impact favorably upon symptoms of other pelvic floor disorders.

NCT ID: NCT02290288 Completed - Clinical trials for Vaginal Vault Prolapse

Prospective Study for Vaginal Vault Prolapse After Hysterectomy: Comparison of Two Surgical Methods

Start date: October 2005
Phase: N/A
Study type: Interventional

The study is carried out at the Sahlgrenska University Hospital and the patient population consists of women referred with symptomatic and bothersome post-hysterectomy vaginal vault prolapse at least 1 cm above or beyond the hymeneal remnants. The interventions are either vaginal sacrospinousfixation or laparoscopic sacrocolpopexy following randomization to one of the types of surgery. The primary outcome is anatomical failure based on clinical assessment. Failure is defined clinically, according to the Pelvic Organ Prolapse Quantification system, as Ba, C or Bp at the hymen or below on maximum Valsalva maneuver one and two years after the surgery. Secondary outcomes are evaluation of continence, sexual function and prolapse symptoms based on validated questionnaires 1, 2, 5 and 10 years after the surgery.