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Prolapse clinical trials

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NCT ID: NCT03052985 Active, not recruiting - Clinical trials for Pelvic Organ Prolapse

Materiovigilance After Urinary Incontinence or Prolapse Surgery

VIGI-MESH
Start date: February 14, 2017
Phase:
Study type: Observational [Patient Registry]

Observatory of Materiovigilance After Surgery of Urinary Incontinence or Prolapse in Women Implantable medical devices (meshes) used in pelvic organ prolapse surgery (genital prolapse, rectal prolapse), or incontinence surgery may be source of severe complications.

NCT ID: NCT03052816 Completed - Pain, Postoperative Clinical Trials

Ice T Postoperative Multimodal Pain Regimen in FPMRS Surgery

ICET
Start date: April 1, 2017
Phase: Phase 4
Study type: Interventional

The purpose of this randomized controlled trial is to determine whether, "ICE-T," a novel multimodal postoperative pain regimen composed of around the clock ice packs, toradol, and tylenol, has improved pain control intake compared to the standard postoperative pain regimen in patients undergoing vaginal pelvic floor reconstructive surgery.

NCT ID: NCT03049020 Recruiting - Clinical trials for Pelvic Organ Prolapse Recurrence

The Efficacy of Laparoscopic Sacrocolpopexy in the Treatment of Pelvic Organ Prolapse in Women With or Without Avulsion of the Levator Ani Muscle

Start date: October 2014
Phase: N/A
Study type: Observational

Based on a prospective study, to evaluate how pre-operative pelvic floor status - the presence of injury to the musculus levator ani - may influence the results of laparoscopic sacrocolpopexy. The investigators hope to confirm or disprove the hypothesis that the presence of such injury increases the risk of post-operative prolapse recurrence

NCT ID: NCT03048682 Recruiting - Surgery Clinical Trials

Timing of Repeat Voiding Trials After Outpatient Pelvic Floor Surgery

Start date: January 5, 2017
Phase: N/A
Study type: Interventional

This study is a randomized controlled trial designed to assess the rate of failure of voiding trials in the early and late post-operative period within patients who underwent outpatient pelvic floor surgery that failed initial same day voiding trials.

NCT ID: NCT03040011 Completed - Surgery Clinical Trials

Preoperative Levator Ani Muscle Injection and Pudendal Nerve Block for Pain Control After Vaginal Reconstructive Surgery

Start date: June 1, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

To test the hypothesis that preoperative injections along the levator ani muscles and pudendal nerve with bupivacaine and dexamethasone improve pain control after vaginal apical reconstructive surgery. A three-arm, double-blinded, randomized controlled trial of a total of 75 women will be performed. The study population will be adult women (>18 years of age) with uterovaginal or vaginal vault prolapse who have been scheduled for native tissue vaginal reconstructive surgery which includes an apical support procedure. Participants will be enrolled prior to surgery. The procedure will involved four injection sites: the bilateral levator ani muscles via a transobturator approach and bilateral pudendal nerves via a transvaginal approach. Random assignment will occur to one of three study arms: combined arm (20 milliliters bupivacaine/dexamethasone solution divided between the 4 injection sites), bupivacaine arm (20 milliliters bupivacaine divided between the 4 injection sites), or placebo arm (20 milliliters saline divided between the 4 injection sites).

NCT ID: NCT03034499 Completed - Clinical trials for Pelvic Organ Prolapse

Single Versus Multi-port Robotic Assisted Sacrocolpopexy for Repair of Vaginal Apex Prolapse

Start date: March 20, 2017
Phase: N/A
Study type: Interventional

A prospective randomized controlled study intended to compare the efficacy of 2 methods of robotic assisted sacrocolpopexy for the repair of vaginal apex prolapse: 1. Via single-port. 2. Via multi-port.

NCT ID: NCT03032848 Completed - Clinical trials for Pelvic Organ Prolapse

Vaginal Estrogens Comparative Trial on Pelvic Organ Prolapse Patients

Start date: November 26, 2013
Phase: Phase 4
Study type: Interventional

To evaluate the difference of three vaginal estrogens creams comparative with placebo on improvement of hormonal cytology, local and systemic climacteric complaints, as well as its endometrial security.

NCT ID: NCT03026738 Not yet recruiting - Rectal Prolapse Clinical Trials

Anterior Versus Posterior Laparoscopic Mesh Rectopexy For Rectal Prolapse; a Randomized Controlled Trial.

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

Aim of this work is to compare results between Laparoscopic Anterior Mesh Rectopexy and Laparoscopic Posterior Mesh Rectopexy for patients with rectal prolapse by assessment of operative time, intraoperative blood loss , intraoperative organ injury, overall length of hospital stay, recurrence,and improvement of incontinence and constipation.

NCT ID: NCT03012464 Recruiting - Rectal Prolapse Clinical Trials

Pathologic Assessment of Rectal Prolapse in the Young

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

Patients aging less than 45 years with rectal prolapse will undergo full pathologic and functional assessment to determine the underlying etiology.

NCT ID: NCT03009968 Completed - Clinical trials for Urinary Incontinence

Reducing Postoperative Catheterization

Start date: March 17, 2017
Phase: N/A
Study type: Interventional

After reconstructive pelvic surgery urinary retention occurs in up to 60% of patients requiring an indwelling catheter or self-catheterization (1-5). Up to 35% of women with acute retention experience urinary tract infections in the postoperative period (6, 7). Many women consider being discharged with a Foley catheter to be a surgical complication and describe catheter use as the worst aspect of their surgery(8). At this time there is no consensus within the field of Female Pelvic Medicine and Reconstructive Surgery (FPMRS) on how to best assess voiding function postoperatively. FPMRS providers both within the United States and around the world utilize a variety of void trial methods and varying criteria to determine adequacy of post-operative voiding efficiency (5). The traditional backfill assisted void trial method involves the assessment of a postvoid residual (PVR) volume obtained either via catheterization or bladder scan (3). Recently, there have been efforts to determine ways to avoid the assessment of a PVR as it is time-consuming and potentially exposes the patient to additional catheterizations (9, 10). Many FPMRS providers utilize the backfill assisted method without assessing a PVR and instead utilize a certain voided volume threshold to determine adequate voiding. However, to date, no one has directly studied this approach or compared the traditional backfill assisted void trial to a PVR-free backfill assisted void trial. By decreasing catheterization and creating a more efficient void trial method, the investigators hope improve patients' postoperative experience and reduce catheterization and risk of urinary tract infection (UTI). This study aims to compare two void trial methodologies in order to help standardize post-operative care in the urogynecology population. This study also has potential to lead to an overall change in our field and improve the postoperative course for women across the country and abroad.