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Prolapse clinical trials

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NCT ID: NCT03582852 Completed - Clinical trials for Pelvic Organ Prolapse

Laparoscopic Sacrocolpexy Versus Lateral Suspension

SUSPENSION
Start date: April 11, 2018
Phase: N/A
Study type: Interventional

Surgical treatment of genital prolapse can be performed by laparoscopic surgery or by vaginal surgery, with or without using meshes. Laparoscopic sacrocolpopexy, which consist in fixing a mesh between vaginal anterior wall and the promontory is the gold standard procedure to treat anterior prolapse or of the vaginal vault. Most of studies shows a success rate of 80% of this procedure. However, access to the promontory could be difficult in patients because of adherences or anatomical reasons. This step of the procedure also exposes to risk of ureteral or vascular injuries. Recent issues have also found spondylodiscitis cases. The technique of laparoscopic lateral suspension with mesh was developed by Dubuisson in 1998 allows not to have to approach the promontory and avoids both the risk of vascular injury and ureteral damage of laparoscopic sacrocolpopexy. Instead of attach the mesh to the promontory, the procedure consists in spreading out bilaterally, a subperitoneal T-shaped mesh in the anterior abdominal wall. The aim of this study is to compare the clinical and functional efficiency of the lateral suspension versus laparoscopic sacrocolpopexy. It is a prospective, randomized, monocentric study compared two groups The study hypothesis is that the lateral suspension would provide correction than the laparoscopic sacrocolpopexy. The primary outcome is the comparison of anatomic correction rates at 1 year Success is defined as 1 year Ba et C points < -1 centimeter in POP-Q international score. Secondary endpoints are improve of quality of life evaluated with the validated P-QOL questionnaire, and complications rates, including post-operative posterior prolapse. Number of subjects required is 72 patients, 36 in each group having a laparoscopic sacrocolpopexy or lateral suspension. Outcomes will be evaluated at 1 month and 1 year post-operative consultation

NCT ID: NCT03582410 Completed - Clinical trials for Pelvic Organ Prolapse

Different Types of Suture for Sacral Colpopexy

Start date: July 10, 2018
Phase: N/A
Study type: Interventional

This randomized controlled study is designed to test absorbable suture compared to non absorbable suture in laparoscopic sacral colpopexy in terms of anatomical correction of the prolapse, post-operative and long term morbidity, rate of recurrence, subjective satisfaction of the patient and rate of mesh erosion.

NCT ID: NCT03573752 Completed - Clinical trials for Pelvic Organ Prolapse

Study of Outpatient Management for Promontofixation by Laparoscopy

Start date: July 26, 2018
Phase: N/A
Study type: Interventional

Laparoscopic promontofixation is becoming increasingly common and is currently the standard surgical procedure for pelvic prolapse, with few complications including exposure and mesh infection. The research hypothesis is that laparoscopic promontofixation is a relatively painless procedure and can be performed on an outpatient basis without increasing the number of postoperative complications and impairing patients' quality of life. The objective of this study is to evaluate the number of rehospitalizations after management of promontofixation by laparoscopy on an outpatient basis. To evaluate the feasibility of a postoperative H8 exit after laparoscopic promontofixation. Each patient will complete a questionnaire on the experience of management, both in terms of pain management, anxiety and overall satisfaction.

NCT ID: NCT03539107 Completed - Clinical trials for Urinary Incontinence

Voiding Assessment Based on Minimum Spontaneous Void of 150 mL Compared to Retrograde Fill Method After Female Pelvic Floor Reconstructive Surgery

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

This study will compare voiding assessment based on a minimum spontaneous voided volume of 150 cc with the standard retrograde fill approach in women after pelvic floor procedures.

NCT ID: NCT03536221 Completed - Clinical trials for Urinary Incontinence

What is the Prevalence of Female Pelvic Floor Disorders in Minnesota?

Start date: August 1, 2018
Phase:
Study type: Observational

To determine the prevalence of pelvic organ prolapse and urinary incontinence among women in Minnesota using a short web-based self-administered questionnaire.

NCT ID: NCT03534830 Completed - Prolapse Genital Clinical Trials

A Novel Assay for Predicting Surgical Outcomes in Pelvic Organ Prolapse

eLASV
Start date: February 2, 2018
Phase:
Study type: Observational

The research objective of this proposal is to investigate the clinical utility and validity of eLASV as a personalized marker for women's individual risk of recurrence for pelvic organ prolapse following advanced surgical procedures. Estimated levator ani subtended volume (eLASV) is a reproducible magnetic resonance image of the female pelvis that objectively quantifies the integrity of the pelvic floor levator ani muscles. A woman's levator ani muscle anatomical shape is unique to her as a result of her own individual lifetime risk for development of pelvic floor dysfunction. The novelty of eLASV as a measurement of muscle integrity, separates it methodology from the solitary of diagnosing partial trauma or defects as previously published within the literature. eLASV measurements have the potential to identify women at increased risk for surgical failure and may be used as a prognostic tool to aid in future counseling and stratification of patients into surgical options for treatment of pelvic organ prolapse.

NCT ID: NCT03524339 Completed - Clinical trials for Pelvic Organ Prolapse

Tamsulosin vs Placebo to Prevent Postoperative Urinary Retention in Female Pelvic Reconstructive Surgery

Start date: August 1, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

This is a placebo controlled randomized controlled trial of perioperative use of tamsulosin to prevent postoperative urinary retention in female pelvic reconstructive surgery.

NCT ID: NCT03516136 Completed - Clinical trials for Pelvic Organ Prolapse

Safety and Performance of the EndoFast Reliant SCP in Vaginal Wall Reinforcement

Start date: January 1, 2015
Phase:
Study type: Observational

A Single arm, single site, retrospective cohort Post Marketing Clinical Follow up Study Evaluating the Safety and Performance of the EndoFast Reliant SCP for apical support.

NCT ID: NCT03494582 Completed - Uterine Prolapse Clinical Trials

Abdominal Versus Vaginal Hysteropexy

Start date: April 1, 2017
Phase: N/A
Study type: Interventional

This study will compare the vaginal versus the abdominal approach for the management of uterine prolapse

NCT ID: NCT03487640 Completed - Clinical trials for Constipation by Outlet Obstruction

Surgical Treatment for ODS With Rectal Prolapse Surgical Treatment for Rectal Prolapse

Start date: January 8, 2018
Phase:
Study type: Observational

Chronic obstinate constipation is hard to deal with in clinic. Especially for obstructed defecation syndrome(ODS). Rectal prolapse is the most common type of ODS. Lots of surgical procedures have been suggested for it but with unsatisfactory results.To develop new surgical treatment and to provide higher quality proof for this intractable condition is of significance.