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Pelvic Organ Prolapse clinical trials

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NCT ID: NCT04306250 Recruiting - Clinical trials for Pelvic Organ Prolapse

Comparison of Posterior and Anterior Approach to Sacrospinous Ligament Apical Fixation - Randomized Controlled Trial

Start date: July 9, 2020
Phase: N/A
Study type: Interventional

Pelvic organ prolapse (POP) is a common problem among women. Apical prolapse (AP) is a prolapse of the uterus, or vaginal cuff, in women post hysterectomy. Apical fixation to the sacrospinous ligament (SSLF) was first introduced in 1968 by K.RICHTER. .In a large review study, the subjective cure rate after SSLF ranged from 70 to 98%, while objective cure rate was 67-97%. The success rates of SSLF in a randomized study comparing SSLF to uterosacral ligament fixation after two years were 63.1%. In women with combined apical and anterior wall prolapse, SSLF can be performed in two ways: anterior access through the anterior vaginal wall or posterior approach through the posterior vaginal wall. A retrospective comparison of the two methods was performed, demonstrating some efficacy to the anterior approach over the posterior approach mainly in respect to the vaginal length. From the literature review to date, no comparisons were made between the methods in a randomized controlled trial. Objective: To compare the success rates between two approaches (anterior and posterior) for SSLF

NCT ID: NCT04275089 Completed - Clinical trials for Pelvic Organ Prolapse

Early Feasibility Study of the Reia Vaginal Pessary

Start date: November 5, 2020
Phase: N/A
Study type: Interventional

This is an early feasibility open-label non-randomized trial to obtain preliminary information about the function and effectiveness of a novel vaginal pessary for the use in women who suffer from symptoms of pelvic organ prolapse (POP). Recruited patients will have Stage II POP or greater and will be current users of a legally marketed vaginal pessary. In a single visit, data will be collected on the performance and comfort of the subject's current pessary. After placement of a study pessary, comparative data will be collected between subject's current pessary and the study pessary on ability to support prolapse. The study pessary's function will be assessed under controlled circumstances. The patient will have her current pessary replaced at the conclusion of the visit. Results will be used to inform future design modifications of the study pessary.

NCT ID: NCT04274491 Completed - Surgery Clinical Trials

Predictors of Recovery Expectancy

Start date: March 1, 2020
Phase:
Study type: Observational

The purpose of this study is to identify factors that influence a person's expectations regarding recovery from pelvic organ prolapse surgery. This is important because a person's expectations regarding recovery from surgery help to predict how a person will actually recover. Our hypothesis is that women with multiple roles will have expectations of a longer surgical recovery time after surgery for pelvic organ prolapse after controlling for known predictors of recovery expectancies. Participants will complete a preoperative online survey. Additional online surveys will be send on postoperative days 14 and 42 to measure postdischarge surgical recovery.

NCT ID: NCT04270188 Active, not recruiting - Clinical trials for Pelvic Organ Prolapse

Evolution of Symptoms After Anterior Sacrospinofixation by Autologous Tissues

SANTAU
Start date: July 21, 2020
Phase:
Study type: Observational

Prolapse is a pathology that can cause pelvic, urinary or sexual functional disorders and impaired quality of life. Although the use of vaginal mesh is a commonly practiced technique to correct prolapse, in recent years health officials have pointed to the lack of adequate safety and tolerability assessments of these implants. Currently, surgeons are therefore moving towards techniques without implants. The standard vaginal technique for the treatment of uterine prolapse is sacrospinofixation according to Richter. This technique can be performed without an implant, using autologous tissue. Functional discomfort of patients is the main problem linked to the presence of prolapse. However, no study has yet evaluated the feelings of patients following the use of this sacrospinofixation technique by autologous tissues by vaginal route, which led us to set up this study. The hypothesis is that the technique of anterior sacrospinofixation by autologous tissues improves the symptoms experienced by patients with an mid-level and / or anterior genital prolapse.

NCT ID: NCT04246996 Completed - Clinical trials for Pelvic Organ Prolapse

Gentamicin Intravesical Efficacy for Infection of Urinary Tract

GIVEIT
Start date: January 29, 2020
Phase: Phase 2
Study type: Interventional

Urinary tract infection (UTI) is a common problem after surgery for pelvic organ prolapse and stress urinary incontinence. This prospective, randomized, single-masked (subject), two-parallel armed study aims to determine the effect of a single postoperative intravesical instillation of 80 mg of gentamicin sulfate in 50 mL of saline versus usual care on the proportion of women treated for UTI within 6 weeks following surgery for pelvic organ prolapse (POP) or stress urinary incontinence (SUI).

NCT ID: NCT04198714 Active, not recruiting - Surgery Clinical Trials

Pudendal Nerve Block in Vaginal Surgery

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

The objective of this this randomized controlled study is to determine whether a pudendal nerve block at the time of vaginal surgery is associated with improved postoperative pain control and decrease opioid consumption compared to a sham pudendal nerve block in patients undergoing vaginal surgery.

NCT ID: NCT04179955 Active, not recruiting - Clinical trials for Pelvic Organ Prolapse

Intraoperative Costs and Patient Perceptions in Sacrocolpopexy for Prolapse

Start date: December 10, 2019
Phase:
Study type: Observational

Robotic sacrocolpopexy (a procedure for female pelvic organ prolapse) has been demonstrated to have equivalent surgical outcomes to open abdominal sacrocolpopexy and has been previously deemed more cost effective due to the longer hospital course following open procedures. The total cost of these procedures, including all costs of hospitalization as well as costs associated with the 30 days following surgery have previously been evaluated by the investigators. However, previous research is lacking in both the specific cost components that contribute to intraoperative cost of surgery as well as the patient perceived outcomes following these two procedures. This project aims to evaluate the marginal costs of surgery and to survey sacrocolpopexy patients to evaluate their satisfaction with outcomes and surgical scars.

NCT ID: NCT04178083 Completed - Clinical trials for Pelvic Organ Prolapse

Comparison of Laparoscopic Sacrohysteropexy, Modified Laparoscopic Lateral Suspension and Laparoscopic Pectopexy.

Start date: January 1, 2020
Phase:
Study type: Observational

The aim of this study was to compare the results of laparoscopic sacrohysteropexy, laparoscopic modified lateral suspens9ion and laparoscopic pectopexy between January 2017 and December 2019 in our clinic.(Patients with at least 12 months of the date of surgery will be called for examination.)

NCT ID: NCT04175782 Completed - Clinical trials for Urinary Incontinence

Enhanced Recovery Protocol in Urogynecologic Surgery

Start date: July 20, 2019
Phase: N/A
Study type: Interventional

Enhanced recovery after surgery (ERAS) has been shown to improve postoperative outcomes in a variety of surgical conditions. However, data regarding its role in urogynecologic surgery is limited. This study aimed to investigate the role of the ERAS protocol on postoperative outcomes in patients undergoing urogynecologic surgery.

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.