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Urogenital Prolapse clinical trials

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NCT ID: NCT04980196 Completed - Urogenital Prolapse Clinical Trials

Is Preoperative Urodynamics Essential for Women With Pelvic Organ Prolapse

urodynaemics
Start date: September 20, 2020
Phase:
Study type: Observational

urodynamic investigation when added in the diagnostic work-up of women with lower urinary tract dysfunction with POP is debatable. This study was planned to determine the usefulness of preoperative urodynamic study in improving urological outcome following surgery in women with pelvic organ prolapse and urinary tract dysfunction.

NCT ID: NCT03766048 Recruiting - Urogenital Prolapse Clinical Trials

LAparoscopic Preventive PRErectal Mesh

LAPREM
Start date: September 11, 2019
Phase: N/A
Study type: Interventional

Urogenital prolapse is a frequent and invalidating pathology in women, involving the anterior vaginal wall and the uterus in most cases. Posterior vaginal wall prolapse is present in only 50% of cases. Surgery is an option for women with troublesome prolapse. A woman's lifetime risk of undergoing surgery for pelvic organ prolapse (POP) surgery by the age of 80 is around 19%. Laparoscopic sacrocolpopexy (LS) with synthetic non-absorbable mesh is considered the gold standard, with a composite success rate of 85% at one year (Prospere study). Based on early experience and historical habits, a prerectal mesh was used to be systematically placed in the rectovaginal space, in addition to the anterior and apical mesh placed in the vesicovaginal space, in order to prevent de-novo posterior prolapse (reported rates up to 33%). The benefit of preventive prerectal mesh is questionned on the basis of a single retrospective study comparing 68 LS with double-mesh (anterior & posterior, DM) to 32 LS with a single anterior mesh (SAM): posterior recurrence rates were respectively 5.9 vs. 31.3% (p<0,01), and total recurrence rates 16.2 vs. 43.8% (p<0.01). However, as this difference was not significant in the subgroup of patients without associated cervicocystopexy, the authors concluded that the risk of posterior failure was only due to the cervicocystopexy itself (anti-urinary incontinence procedure which has been abandoned since). On the other hand, a prerectal mesh increases the risk for specific complications: rectal injury (up to 3%), anal pain (up to 25%), mesh exposition (up to 2%). Furthermore the posterior mesh increases the procedure by a minimum of 30 minutes (Robolaps study, unpublished data). The rate of de-novo obstructed defecation after LS with prerectal mesh is reported up to 25%. It could be explained by the mesh itself, but also by nerve injuries during the dissection of the rectovaginal space and rectal stalks.

NCT ID: NCT03005613 Recruiting - Urogenital Prolapse Clinical Trials

Sacrospinous Ligament Fixation vs Ischial Spine Fascia Fixation

Start date: January 2017
Phase: N/A
Study type: Interventional

A Prospective, Randomized Comparison of Efficacy and Effect on Quality of Life Between Sacrospinous Ligament Fixation and Ischial Spine Fascia Fixation.

NCT ID: NCT02431897 Completed - Clinical trials for Pelvic Organ Prolapse

Investigation to Minimize Prolapse Recurrence of the Vagina Using Estrogen

IMPROVE
Start date: December 2016
Phase: Phase 4
Study type: Interventional

This study randomizes postmenopausal women with symptomatic pelvic organ prolapse planning native tissue transvaginal surgical repair to 6-8 weeks of preoperative and 1-year continued postoperative vaginal estrogen cream compared to placebo cream. This clinical trial and basic science investigation are designed to understand the mechanisms by which local estrogen treatment affects connective tissues of the pelvic floor and determine whether its use before and after prolapse repair will (i) improve success rates of the surgical intervention and minimize prolapse recurrence and (ii) impact favorably upon symptoms of other pelvic floor disorders.