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Prolapse clinical trials

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NCT ID: NCT01171846 Completed - Clinical trials for Pelvic Organ Prolapse

A Study of the Effects of Physiotherapy to Prevent Pelvic Organ Prolapse

PREVPROL
Start date: August 2010
Phase: N/A
Study type: Interventional

Pelvic organ prolapse is a problem experienced by women where a bulge comes down in the vagina, and may even drop down outside the vagina. The bulge in the vagina is caused by other organs moving down from their normal position in the pelvis and pushing into the vagina. This is a very common problem and many women who have given birth will have a very mild bulge which does not cause them symptoms. Women can however experience a variety of pelvic, bladder, bowel and sexual symptoms which impact on daily life. No research studies have properly examined whether or not exercises can prevent prolapse. This study aims to explore whether exercises taught by a physiotherapist can prevent women developing a prolapse which requires them to have treatment.

NCT ID: NCT01166373 Completed - Clinical trials for Pelvic Organ Prolapse

The Extended Operations And Pelvic Muscle Training In The Management Of Apical Support Loss Study

E-OPTIMAL
Start date: April 2010
Phase: N/A
Study type: Interventional

Women will be invited to participate in E-OPTIMAL at their last clinical follow-up visit for OPTIMAL (at 24 months post surgery). E-OPTIMAL is an extension of the ongoing OPTIMAL study and no new study treatment interventions will be given. Rather an enrollment intervention will be investigated with potential E-OPTIMAL participants randomly assigned to watch a standardized video prior to consent or undergo the standard informed consent process. The standardized video will review the rationale for women's health research, the importance of long-term follow-up and a detailed invitation to participate in E-OPTIMAL. The video has undergone review by potential subjects, coordinators and physician researchers to ensure that the relevance and importance of issues potentially impacting on long-term participation in studies such as E-OPTIMAL are covered. Participation in E-OPTIMAL will occur up to three additional years. Women will be strongly encouraged to participate in annual examinations and annual telephone surveys but may participate in only one of these study parts if needed. We propose to test the following null hypotheses: 1. There will be no difference in time to surgical failure between uterosacral vaginal vault ligament suspension (ULS) and sacrospinous ligament fixation (SSLF) up to 5 years after surgery. 2. The addition of a standardized video detailing the importance of long-term follow-up studies for POP to the informed consent process will not improve enrollment or retention in E-OPTIMAL.

NCT ID: NCT01136889 Completed - Clinical trials for Pelvic Organ Prolapse

PEssary Plus Physiotherapy for Pelvic Organ Prolapse (PEPPY)

PEPPY
Start date: April 2008
Phase: N/A
Study type: Interventional

1. To determine the feasibility of conducting a randomised controlled trial (RCT) of the effectiveness of a PFMT intervention in conjunction with vaginal pessary management versus vaginal pessary management alone for women with pelvic organ prolapse. 2. To develop and test the methods for a main trial. The ultimate aim of a large multi-centre RCT would be to answer the question: Is conservative management of pelvic organ prolapse with an individualised PFMT intervention in conjunction with vaginal pessary more effective than vaginal pessary alone in reducing prolapse-specific symptoms, prolapse severity and the need for further prolapse treatment?

NCT ID: NCT01134003 Completed - Clinical trials for Pelvic Organ Prolapse

A Large Multi-Center Database of Women Who Have Had and Are Going to Have Surgical Correction of Their Pelvic Organ Prolapse Using the Gynecare Prolift System

Start date: January 2008
Phase: N/A
Study type: Observational

retrospective and prospective data collection for a database. Patients will have had or are going to have a repair of their pelvic organ prolapse using the Gynecare mesh Prolift System

NCT ID: NCT01111916 Completed - Clinical trials for Pelvic Organ Prolapse

Development Study Using Vaginal Tactile Imager

Start date: March 2010
Phase:
Study type: Observational

The objective is to evaluate and optimize tactile imaging technology in evaluation of tissue elasticity parameters in the female pelvis.

NCT ID: NCT01111409 Completed - Clinical trials for Pelvic Organ Prolapse

A Pilot Study to Evaluate the Clinical Effectiveness and Safety of the VFIX Device as Treatment for Apical Prolapse

Start date: March 2010
Phase: N/A
Study type: Interventional

The primary objective of this pilot study is to evaluate the safety and effectiveness of the VFIX device in maintaining vaginal apical support for at least 6 months in women with symptomatic apical prolapse (upper vaginal or uterine prolapse).

NCT ID: NCT01095692 Completed - Clinical trials for Pelvic Organ Prolapse

Evaluating the Necessity of TOT Implantation in Women With Pelvic Organ Prolapse and Occult Stress Urinary Incontinence

ATHENA
Start date: July 2010
Phase: N/A
Study type: Interventional

Nowadays the clinical significance of an occult stress urinary incontinence and its optimal treatment is not known.Regarding treatment, there are 2 main approaches : either the systematic preventive treatment of the occult stress urinary incontinence by means of a tension free vaginal tape (TOT) together with the treatment of prolapse or the treatment of prolapse in the first place and treatment of stress incontinence in a second time when and if it appears.This study is expected to provide objective evidence concerning the efficacy and security of TOT implantation for the prevention treatment of occult stress urinary incontinence in women with pelvic organ prolapse and occult urinary incontinence.The perspective is to improve the management of these patients by providing evidence based recommendation for their treatment.

NCT ID: NCT01084889 Completed - Cystocele Clinical Trials

Anterior Pelvic Prolapse Reconstruction With TiLOOP® Total 6

Start date: April 2010
Phase:
Study type: Observational

The purpose of this study is to determine the influence of Anterior Pelvic Prolapse Reconstruction with a titanised polypropylene mesh on rate of erosion and patients quality of live.

NCT ID: NCT01055860 Completed - Clinical trials for Urinary Incontinence

One Year Outcome After Robotic Assisted Laparoscopic Sacral Colpopexy, a Case Series Review

Start date: February 2009
Phase: N/A
Study type: Observational

Robotic approach to sacral colpopexy is a relatively new procedure. The literature is scarce in regard to its long-term outcomes. This advanced procedure is offered at MMH through the Urogynecology division. The Investigators setup to 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: NCT01022034 Completed - Rectal Prolapse Clinical Trials

Pexy Versus Non-pexy for Full Thickness Rectal Prolapse

Bergamaschi
Start date: January 2003
Phase: Phase 3
Study type: Interventional

No randomized controlled trial (RCT) has compared no rectopexy to rectopexy for external full‐thickness rectal prolapse (FTRP). This study was performed to test the hypothesis that recurrence rates for FTRP following no rectopexy are not inferior to those for rectopexy. Method: This is a multicenter randomized non‐inferiority trial. Eligible patients were randomized to no rectopexy or rectopexy. The no rectopexy arm was defined as abdominal surgery with rectal mobilization only. The rectopexy arm was defined as abdominal surgery with mobilization and pexy. Sigmoid resection was not randomized and was added in the presence of constipation. The endpoint was recurrence rates defined as presence of external FTRP after surgery. A pre‐RCT meta‐analysis suggested a sample size of 251 patients based on a 15% expected difference in the 5‐year cumulative recurrence rate. Recurrence‐free curves will be generated and compared using the Kaplan‐Meier method and log‐rank test, respectively. A Bonferroni adjustment was used. An adjusted p value of <0.01 was considered significant.