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Prolapse clinical trials

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NCT ID: NCT01378065 Completed - Clinical trials for Pelvic Organ Prolapse (POP)

Restorelle Direct Fix Anterior and Posterior (A&P) for Female Pelvic Organ Prolapse: A Prospective Post Market Study

(A&P)
Start date: June 2011
Phase:
Study type: Observational

This is a prospective, multi-center study designed to assess the palpability of the Restorelle Direct Fix A&P mesh after vaginal reconstruction surgery.

NCT ID: NCT01377142 Completed - Clinical trials for Pelvic Organ Prolapse

Vaginal Uphold Hysteropexy and Laparoscopic Sacral Hysteropexy for the Treatment of Uterovaginal Pelvic Organ Prolapse

VAULT
Start date: June 2011
Phase: N/A
Study type: Observational

The purpose of this study is to evaluate surgical success or failure one year after surgery for pelvic organ prolapse.

NCT ID: NCT01321762 Completed - Clinical trials for Pelvic Organ Prolapse

Prolapse and Pregnancy Assessment

PAPA
Start date: April 2005
Phase: N/A
Study type: Observational

Pelvic organ prolapse (POP) is one of the most common indications for gynaecological surgery. In 1997, more than 225000 inpatient surgical procedures for POP were undertaken in USA (22.7 per 10000 women) at an estimated cost of more than one billion dollars. In the UK, the disorder accounts for 20% of the women on the waiting list for major gynaecological surgery. Vaginal birth, advancing age and increasing body mass are the most consistent risk factors. Furthermore a racial and congenital predisposition has been reported. The cause of this disorder is likely to be multifactorial and attributable to a combination of factors, varying from patient to patient. Controversy exists as to whether the pregnancy per se rather than the mode of delivery alters the risk of POP. Caesarean section appears to protect against the development of prolapse. However, when a caesarean section is undertaken during the active stage of labour it may not be completely protective. Ideally prospective longitudinal studies are needed to study the impact of pregnancy and childbirth on pelvic organ prolapse. Unfortunately, studies to date, are small with poor follow-up and have only assessed objective outcome rendering it difficult to draw conclusions. The primary objective of our study was to objectively assess the impact of pregnancy and childbirth on pelvic organ support using the Pelvic Organ Prolapse Quantification (POPQ)System.

NCT ID: NCT01320644 Completed - Clinical trials for Urinary Incontinence

A Study of Robotic Assisted Laparoscopic Sacral Colpopexy Using Alyte Mesh

ALYTE
Start date: August 2010
Phase: N/A
Study type: Observational

Robotic approach to sacral colpopexy is a relatively new procedure. The literature is scarce in regard to long term outcomes. This advanced procedure is offered at Morristown Memorial. THis protocol will review the one year outcome of patients who underwent this pocedure using a polypropylene mesh. These outcomes will incude anatomical and quality of life measures.

NCT ID: NCT01320631 Completed - Clinical trials for Pelvic Organ Prolapse

Male Sexual Experience and Its Impact on Quality of Life Before and After Their Sexual Partners Undergo Polypropylene Mesh Augmented Pelvic Floor Reconstruction

SEXQ
Start date: September 2009
Phase: N/A
Study type: Observational

The correction of the pelvic organ protrusion is aimed at restoring the pelvic floor functional status and ultimately improving the patient's quality of life. There are a few studies that have explored the effect of pelvic reconstructive surgery on female sexual function (1,2) but no studies have evaluated the male partner's sexual experience. The investigators intend to use a newly psychometrically validated questionnaire to capture this aspect. The sexual experience questionnaire (SEX-Q) is the first questionnaire to solely and exclusively combine functional and quality of life concepts (erection, individual satisfaction, and couple satisfaction domains) in a brief questionnaire, which allows a more focused and less burdensome evaluation of the sexual experience in men (3). Another issue is the density of the mesh material and if it can be felt vaginally even if it is not eroded and to what degree this might bother the male partner during intercourse.

NCT ID: NCT01320618 Completed - Clinical trials for Urinary Incontinence

Prospective Cohort Study of Robotic Assisted Laparoscopic Sacrocolpopexy Using MPATHY Restorelle Mesh

MPATHY
Start date: May 2009
Phase: N/A
Study type: Observational

Robotic approach to sacral colpopexy is a relatively new procedure. The literature is scarce in regard to long term outcome. This advanced procedure is offered at Morristown Memorial. This protocol will review the one year outcome of patients who underwent this procedure using a polypropylene mesh. These outcomes will include anatomical and quality of life measures.

NCT ID: NCT01320215 Completed - Clinical trials for Pelvic Organ Prolapse

Complications Associated With Promontofixation for Pelvic Organ Prolapse: Comparing Robot Assisted Laparoscopic and Non-robot Assisted Laparoscopic Surgical Procedures

RoboLaps
Start date: June 22, 2011
Phase: N/A
Study type: Interventional

The primary objective of this study is to compare 30-day complication rates associated with promontofixation for pelvic organ prolapse performed via a robot-assisted laparoscopic technique versus a non-robot-assisted laparoscopic technique. Secondary objectives include comparing technical data, anatomical correction, prolapse recurrence, incontinence, quality of life and medico-economic data between the two techniques. The patient diary did not allow the collection of sufficiently precise data to meet the secondary medico-economic objective of the study. Access to data from the National Health Data System (SDNS), which was not available at the time of the initial drafting of this protocol, now makes it possible to obtain a complete picture of patients' health care consumption. We propose, therefore, to extract data from the SNIIRAM via the SNDS (matching of patients' NIR to their health care consumption) in order to retrieve and accurately estimate the cost of follow-up.

NCT ID: NCT01244165 Completed - Clinical trials for Vaginal Vault Prolapse

Study of Cytrix Use in Pelvic Floor Prolapse Treatment

Start date: January 2002
Phase: Phase 4
Study type: Interventional

To evaluate safety and effectiveness of using the fetal bovine dermis (Cytrix) in the treatment of pelvic organ prolapse.

NCT ID: NCT01190618 Completed - Vaginal Prolapse Clinical Trials

Surgical Outcomes of Vaginal Prolapse Repair With Elevate

Start date: August 2010
Phase: N/A
Study type: Observational

The purpose of this study is to evaluate outcomes in patients having vaginal prolapse repair with the Elevate prolapse repair kit and compare these outcomes to patients who had a repair with Prolift. .

NCT ID: NCT01182090 Completed - Clinical trials for Pelvic Organ Prolapse

Surgical Correction of Pelvic Organ Prolapse

Start date: August 2010
Phase: Phase 3
Study type: Interventional

Objective: This prospective randomized trial evaluated outcomes of colposacropexy performed either by open or by conventional laparoscopic approach as therapy for uterovaginal prolapse. Surgical techniques, efficacy and overall results are compared. Methods: In this prospective study 40 consecutive patients with uro-genital prolapse are randomized to sacropexy: 20 by an open approach, 20 by a conventional laparoscopy approach. Anchorage is achieved in both groups by two polypropylene meshes. Check-ups were scheduled at 3, 6, 12 months and then yearly. Pre-operative patient characteristics, operative and post-operative events and follow-up results are recorded.