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Prolapse clinical trials

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NCT ID: NCT02774798 Completed - Clinical trials for Pelvic Floor Disorders

Correlation of Anal Acoustic Reflectometry Parameters With Degree of Rectal Intussusception and Prolapse

Start date: April 2016
Phase:
Study type: Observational

Anal Acoustic Reflectometry (AAR) is a reliable and reproducible technique that has been studied in our department over the last 6 years. Sound waves pass into a balloon placed in the anal canal and are used to measure the cross-sectional area. By gradually increasing and decreasing the pressure in the balloon the investigators can measure the pressure at which the cross-sectional area starts to increase and decrease, and the anal canal starts to open and close. This assessment mimics the natural opening and closing of the anal canal and the effect of squeezing the muscles. Rectal intussusception occurs when the rectal wall telescopes into itself distally and is termed prolapse when it protrudes through the anal canal. Not all patients will require surgery and, for some, it can lead to debilitating symptoms of constipation, pain and faecal incontinence. Currently, the Oxford grading system through radiological testing is used for classifying severity of rectal intussusception and prolapse; however this does not give us sufficient information about the anal sphincter muscles. The gold standard investigation of the anal sphincter muscles has been manometry which measures anal canal pressure at rest and during squeeze. However, it has limitations. In previous studies AAR has shown promise in the assessment of faecal incontinence and, that unlike manometry, it has been able to distinguish between different types of incontinence. Thus far, it has not been studied in patients with rectal intussusception and it is hoped that AAR parameters may provide an indication of when rectal intussusception becomes overt rectal prolapse. This can inform the clinician to guide further management of a group of patients with a condition that can have significant impact on quality of life.

NCT ID: NCT02771275 Completed - Clinical trials for Mitral Valve Insufficiency

Safety and Early Feasibility Study of the Harpoon Medical Device (EFS)

EFS
Start date: February 15, 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the safety and performance of the Harpoon Medical TSD-5. The Harpoon device will provide many significant advantages over current surgical interventions including: 1) a small minimally invasive incision, 2) no sternotomy, 3) no cardiopulmonary bypass, 4) no aortic manipulation, 5) a direct path to the valve plane, 6) performed on a beating heart, 7) real-time TEE-guided chordal length adjustment and 8) less complicated procedure that is teachable and adoptable.

NCT ID: NCT02768870 Completed - Clinical trials for Mitral Valve Insufficiency

CE Mark Study for the Harpoon Medical Device

TRACER
Start date: April 28, 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the safety and performance of the Harpoon Medical device. It is anticipated, that the Harpoon Medical device will provide advantages over current surgical interventions including: 1) a small minimally invasive incision, 2) no sternotomy, 3) no cardiopulmonary bypass, 4) no aortic manipulation, 5) a direct path to the valve plane, 6) performed on a beating heart, 7) real-time TOE-guided chordal length adjustment and 8) less complicated procedure that is teachable and adoptable.

NCT ID: NCT02758561 Completed - Clinical trials for Pelvic Floor Disorders

Motivational Interviewing in Women`s Pelvic Wellness Education

Start date: May 2016
Phase: N/A
Study type: Interventional

This pilot study will assess the feasibility and acceptability of an educational workshop on pelvic floor disorders and its potential impact on decisional conflict.

NCT ID: NCT02753920 Completed - Clinical trials for Vaginal Apical Prolapse

Comparing Force of Stream to Retrograde Fill Voiding Trial After Vaginal Apex Suspension

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

Voiding difficulties are common after prolapse and incontinence surgeries. All patients after vaginal prolapse surgery must complete a voiding trial if they are to be discharged home without a catheter. Accepted protocols for voiding trials after prolapse and incontinence surgeries do not exist. The purpose of this study is to compare two different types of postoperative voiding trials to determine which leads to less postoperative issues, such as urinary retention requiring catheterization. You are being asked to participate because you are having a vaginal apex suspension surgery.

NCT ID: NCT02751073 Completed - Clinical trials for Pelvic Organ Prolapse

Evaluation of the Relationship Between Vaginal and Lower Urinary Tract Microbiomes and Infection After Hysterectomy

Start date: February 2016
Phase:
Study type: Observational

The purpose of this study is to learn more about the microbes (bacteria) that live in the vagina and the bladder. The investigators are doing this research study to understand the relationship between microbes (the microbiome) and the occurrence of urinary tract infection following surgical removal of the uterus and pelvic organ prolapse repair. The investigators expect Lactobacillus and Gardnerella will be the dominant organisms for most women. Non-Lactobacillus dominant microbiome communities will be more common in women who ultimately develop postoperative urinary tract infection.

NCT ID: NCT02741830 Completed - Clinical trials for Pelvic Organ Prolapse

Uterosacral Ligament Suspension vs Robotic Sacrocolpopexy

Start date: April 7, 2016
Phase:
Study type: Observational

This cross sectional, two cohort study seeks to investigate both anatomic outcome and subjective, functional outcome of uterosacral ligament suspension versus robotic sacrocolpopexy and compare patient satisfaction, bladder function, sexual function and complication rate for each procedure.This study will provide a better understanding about the durability of these procedures and long term complication.

NCT ID: NCT02727322 Completed - Clinical trials for Pelvic Organ Prolapse

Nitrofurantoin Prophylaxis During Catheter-managed Acute Urinary Retention After Pelvic Reconstructive Surgery

Start date: August 2016
Phase: Phase 4
Study type: Interventional

The specific aim of this randomized double-blind placebo-controlled trial is to determine if extended release nitrofurantoin antibiotic prophylaxis decreases the incidence of symptomatic urinary tract infection (UTI) compared with placebo for patients undergoing short term indwelling or clean intermittent self-catheterization (CISC) for acute postoperative urinary retention following pelvic organ prolapse and/or urinary incontinence surgery. Consented patients who undergo urogenital surgery and fail their post-operative voiding trial will be randomized to either extended release nitrofurantoin 100mg or an identical appearing placebo capsule to be taken daily while performing CISC or while indwelling catheter is in place. The primary outcome will be symptomatic and culture confirmed UTI within six weeks of surgery. Secondary outcomes include adverse events associated with nitrofurantoin use, and incidence of nitrofurantoin-resistant isolates from urine culture of symptomatic women. Primary and secondary outcomes will be evaluated with Student t test and chi squared or Fisher exact test as appropriate. Assuming a decrease in symptomatic UTIs attributable to nitrofurantoin prophylaxis from 33% to 13%, with 80% power, and a two-sided alpha of 0.05, and a 10% dropout rate, we should recruit a total of 154 patients.

NCT ID: NCT02700997 Completed - Clinical trials for Pelvic Organ Prolapse

Uterosacral Ligament Suspension Clip

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

This study seeks to gain a more thorough understanding of the postoperative location of the sutures placed during uterosacral ligament suspension. Characterization of the surrounding anatomy in a living model will enhance surgical technique by delineating safer suture locations and decrease the incidence of morbid complications for patients.

NCT ID: NCT02690220 Completed - Cystocele Clinical Trials

Anterior Pelvic Prolapse Reconstruction With TiLOOP® PRO A Polypropylene Mesh

Start date: February 1, 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to determine the influence of anterior pelvic prolapse reconstruction with a titanized polypropylene mesh on patients quality of life.