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Pelvic Organ Prolapse clinical trials

View clinical trials related to Pelvic Organ Prolapse.

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NCT ID: NCT02246387 Completed - Clinical trials for Pelvic Organ Prolapse

Follow-up Study After Manchester Operation for Pelvic Organ Prolapse

MAP-POP
Start date: October 2014
Phase:
Study type: Observational

Native tissue repair for pelvic organ prolapse (POP) is the predominant surgical technique in the investigators department and the Manchester operation the preferred procedure. The investigators long-term reoperation rates for pevic organ prolapse are very low, as documented in the investigators previous long-term follow-up study (Oversand et al, International Urogynecology Journal 2013), however the data were retrospective and patients with avulsions of the levator ani muscle were not identified. The investigators hypothesize that correct fixation and elevation of the vaginal apex, as part of a three-compartment repair procedure, is essential in the POP surgical repair, also when treating women with levator ani avulsions. The purpose of this study is to: - prospectively evaluate if cardinal/sacrouterine ligament plication (as part of the 3-compartment Manchester procedure) gives an adequate elevation and fixation of the vaginal apex. - assess changes in subjective symptoms between the preoperative evaluation and the 1 and 5-year postoperative evaluations. - evaluate whether the patients identified with levator avulsions in the investigators population have an increased risk of failure (objectively and subjectively).

NCT ID: NCT02216253 Completed - Clinical trials for Urinary Incontinence

L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract to Prevent Postoperative Urinary Tract Infection.

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

This study will include women who will undergo pelvic reconstructive surgery and/or anti-incontinence sling procedures. Patients will be randomized to the combination of L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract in tablet or placebo twice a day during the seven days before and after surgery (total of 14 days). In this randomized, double-blind study, the investigators will assess treatment of clinically suspected or culture-proven urinary tract infections within 3 weeks of surgery (primary outcome), and risk factors for treatment for postoperative urinary tract infections (secondary outcomes) between the two study groups.

NCT ID: NCT02209337 Completed - Clinical trials for Anterior Vaginal Wall Prolapse

Demonstrate the Safety and Preformance of the SRS Device for the Treatment of Pelvic Organ Prolapse

Start date: September 2014
Phase: N/A
Study type: Interventional

A prospective, single arm, pre-market, multi-center clinical study to evaluate the safety and performance of the SRS (Lyra Medical) vaginal mesh in POP patients

NCT ID: NCT02190825 Completed - Clinical trials for Pelvic Organ Prolapse

Safety and Efficacy Study of the NeuGuide Device

Start date: November 2014
Phase: N/A
Study type: Interventional

This study aims to investigate the safety, efficacy, peri and postoperative complications, and patient satisfaction of sacro-spinous ligament fixation (SSLF) for the management of pelvic organ prolapse (POP). Prolapse staging for all subjects in this study will be performed according to the POP-Q staging system. Ultrasound examinations for all subjects in this study are subjected to the surgeon need and will be performed if required by qualified personnel

NCT ID: NCT02189291 Completed - Clinical trials for Pelvic Organ Prolapse

Study to Assess Duration of Indwelling Catheter After Sacrocolpopexy

CARESS
Start date: July 2014
Phase: N/A
Study type: Interventional

Objectives The objective of this study is to help identify the best practice regarding the use of indwelling catheter after minimally invasive urogynecologic surgery. Investigators propose a randomized controlled trial comparing the immediate removal of indwelling urethral catheter, after minimally invasive sacrocolpopexy, to the present standard catheter removal on post operative day one. Evidence based catheter management will be helpful to both providers and patients in post-operative decision making. Specific Aims Aim 1: To demonstrate that immediate removal of catheter after minimally invasive sacrocolpopexy results in shorter hospital stay than removal on postoperative day 1. Aim 2: To demonstrate that immediate removal of catheter after minimally invasive sacrocolpopexy confers no increased risk of re-catheterization. Aim 3: To demonstrate that immediate removal of catheter after minimally invasive sacrocolpopexy decreases the occurrence of urinary tract infection. Design A randomized controlled trial comparing the standard overnight indwelling urethral catheterization with removal of catheter immediately post surgery after minimally invasive sacrocolpopexy, at Oregon Health & Science University. Outcome measures Primary outcome measures are hospital stay in hours after completion of surgery and need for re-catheterization. Hospital stay will be counted from the time the patient leaves the operating room to the time she leaves the hospital. To avoid confounding, investigators are only including the first / morning case of the day. For re-catheterization, investigators will evaluate if patient was able to void after completion of surgery. Investigators will compare the post voiding residuals, the need for re-catheterizations and the numbers of patients going home with an indwelling catheter between the two groups. Investigators will also compare the number of urinary tract infections, as documented by urine culture and subsequent treatment, between the two groups. Study Subjects Study subjects will be women undergoing minimally invasive sacrocolpopexy. Women will be invited to participate in the study during their preoperative visit. If they agree to participation, this will be noted in their chart. Randomization to group will occur immediately following surgery.

NCT ID: NCT02178735 Completed - Clinical trials for Pelvic Organ Prolapse

Clinical Outcomes and Urodynamic Effects After Vaginal Tailored Mesh Surgery for Pelvic Organ Prolapse

Start date: May 2014
Phase: Phase 4
Study type: Interventional

To evaluate the clinical outcome and urodynamic effect of two novel vaginal tailored mesh surgeries.

NCT ID: NCT02165280 Completed - Clinical trials for Pelvic Organ Prolapse

Guided IMagery and Patient Satisfaction (GIMPS) Following Urogynecological Surgery

GIMPS
Start date: June 2014
Phase: N/A
Study type: Interventional

We hypothesize that women who use GIM pre-operatively will feel more prepared for surgery, have less anxiety on the day of surgery and have higher satisfaction scores 6 weeks after surgery compared to women who undergo our routine pre-operative care.

NCT ID: NCT02162615 Completed - Clinical trials for Pelvic Organ Prolapse

Restorelle® Mesh Versus Native Tissue Repair for Prolapse

Start date: August 2014
Phase:
Study type: Observational

The purpose of this study is to collect information on the safety and effectiveness of Restorelle Direct Fix mesh and the surgical procedure to implant Restorelle. These results will be compared to the safety and effectiveness results in patients who have native tissue repair (without mesh) as their pelvic organ prolapse treatment.

NCT ID: NCT02155738 Completed - Clinical trials for Pelvic Organ Prolapse

IV Acetaminophen for Postoperative Pain After Pelvic Organ Prolapse Repair

Start date: July 2014
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine whether preoperative IV Acetaminophen reduces postoperative pain and narcotic consumption in women undergoing surgical repair of pelvic organ prolapse.

NCT ID: NCT02138487 Completed - Clinical trials for Pelvic Organ Prolapse

Restricted Convalescence: Outcomes Following Urogynecologic Procedures

ReCOUP
Start date: August 2014
Phase: N/A
Study type: Interventional

The investigators are conducting a study to better understand the relationship between activity restrictions and women's satisfaction following urogynecologic surgery for prolapse. We hypothesize that women with less stringent postoperative restrictions will have higher levels of satisfaction 12 weeks following surgery with no difference in respect to anatomic outcome.