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Prolapse clinical trials

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NCT ID: NCT02105480 Completed - Clinical trials for Mitral Valve Prolapse

Automated Algorithm Based Analysis of Phonocardiograms of Newborns

Start date: November 2013
Phase:
Study type: Observational [Patient Registry]

The purpose of this double-blind pivotal clinical utility study is to determine on a large patient population whether heart murmurs can be reliably detected with high sensitivity and specificity using a locked, automated algorithm-based phonocardiogram analysis (also referred to as computer aided auscultation (CAA)). Each patient is auscultated and diagnosed independently by a medical specialist. Additionally, for each patient, an echocardiogram is performed as the gold-standard for determining heart pathologies. The CAA results are compared to the findings of the medical professionals as well as to the echocardiogram findings. Hypothesis: The specific (locked) CAA algorithms used in this study are able to automatically diagnose pathological heart murmurs in premature babies and newborns with at least the same accuracy as experienced medical specialists.

NCT ID: NCT02092623 Completed - Clinical trials for Female Genital Prolapse

Single Incision Transvaginal Mesh in Treatment of Posterior Vaginal Wall Prolapse

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

Definition: To find out complications, objective and subjective outcomes of patients with symptomatic posterior vaginal wall prolapse undergoing posterior mesh operation in nine Finnish hospitals during September 2010 and August 2013. The study hypothesis is that complications are acceptable and both objective and subjective outcomes are satisfying.

NCT ID: NCT02076360 Completed - Prolapse Clinical Trials

RCT: Impact of Preop Video on Patient Preparedness for Surgery

Start date: August 2013
Phase: N/A
Study type: Interventional

This is a single-blind, randomized (1:1 allocation), stratified, single-parallel clinical trial at one institution evaluating the use of a preoperative patient education video as an adjunct to preoperative counseling on patient-centered outcomes. The aim of this study is to determine the impact of a preoperative patient educational video as an adjunct to the routine preoperative visit on patients' preparedness for surgery, perception of time spent with their healthcare team, and ultimately their satisfaction after surgery. The aim of this video is not to limit the doctor patient interaction (as all patients will still be granted their pre-allotted 30 minute visit with the physician regardless of their intervention allocation) but rather to augment the visit with additional educational information in an attempt to optimize the visit. Objective: A. Primary Aim(s): • To determine if patients feel more prepared for surgery with addition of preoperative patient education video B. Secondary Aim(s): - To determine if addition of preoperative patient education video correlates with improved patient satisfaction after surgery - To determine if patients' perception of time spent with healthcare team in preparation for surgery increases with addition of patient educational video - To determine if actual patient-physician time spent counseling differs between groups - To determine if patient preparedness is correlated with objective surgical outcomes - To determine if patient preparedness is correlated with patient symptom improvement scores after surgery Hypothesis: The addition of a preoperative patient education video enhances patient preparedness for surgery, increases perception of the amount of time patients spend with healthcare team, and improves patient satisfaction.

NCT ID: NCT02073734 Completed - Clinical trials for Pelvic Organ Prolapse

Effects of Preoperative Dexamethasone Study on QOL After Vaginal Reconstructive Surgery for POP

Start date: February 2013
Phase: Phase 3
Study type: Interventional

The investigators hypothesize that preoperative administration of 8 mg IV dexamethasone will benefit patients' perceived quality of recovery after surgery.

NCT ID: NCT02049996 Completed - Clinical trials for Pelvic Organ Prolapse

Difference in Pain, Quality of Life Following Vaginal Hysterectomy With Vaginal Reconstruction Versus Robotic Colpopexy?

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

The purpose of this study is to to determine if there is a difference in patient related outcomes of pain and quality of life following vaginal hysterectomy with vaginal prolapse repair compared to robotic-assisted repair. We hypothesize that pain and quality of life following robotic-assisted repair will be similar to that following vaginal reconstruction, when performed in conjunction with vaginal hysterectomy.

NCT ID: NCT02021279 Completed - Clinical trials for Pelvic Organ Prolapse

ACell MatriStem Pelvic Floor Matrix Versus Native Tissue Repair, Comparative Study

Start date: June 11, 2014
Phase: N/A
Study type: Interventional

The primary objective of this study is to assess the safety and effectiveness of MatriStem Pelvic Floor Matrix as compared to native tissue repair for the treatment of pelvic organ prolapse. Patients are evaluated throughout a 3 year follow-up period.

NCT ID: NCT02011373 Completed - Clinical trials for Medial and/or Anterior Genital Prolapse

Efficacy of IFABONDTM Synthetic Glue for Fixation of Implanted Material in Laparoscopic Sacrocolpopexy: a Prospective Multicenter Study

PRO-COLLE
Start date: November 6, 2013
Phase: N/A
Study type: Interventional

Laparoscopic sacrocolpopexy is the consensual attitude of choice in genital prolapse but incurs problems of tolerance of implanted material. As an alternative to stapling and suturing, which cause vaginal erosion, we present a fixation technique using a sterile synthetic liquid tissue glue: IFABOND™. A non-randomised prospective multicenter study will assess efficacy in terms of 12-month failure of prolapse correction.

NCT ID: NCT01997996 Completed - Clinical trials for Pelvic Organ Prolapse

ProViS (Prolift+M and Vita Sexualis) Study

ProViS
Start date: May 2011
Phase: N/A
Study type: Observational

Transvaginal meshes (TVM) are indicated for the treatment of pelvic organ prolapse (POP) where surgical intervention is necessary. Due to a potential risk of de novo dyspareunia, TVM are mainly used in postmenopausal women and in case of recurrent POP. PROLIFT+M (Trademark) is based on a highly flexible material which is partially absorbable. We suggest that PROLIFT+M has less impact on the vita sexualis than conventional TVM and could also be used for the treatment of younger and/or sexually active women. This study observes women who are routinely treated with PROLIFT+M with regard to their sexual function before and after the surgery. The hypothesis is that there is no worsening in vita sexualis with PROLIFT+M.

NCT ID: NCT01980043 Completed - Rectal Prolapse Clinical Trials

Endoluminal and Needlescopic Assisted Repair of Rectal Prolapse

Start date: May 20, 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the safety and feasibility of endoluminal rectal prolapse repair under sedation and local anesthesia using CO2 colonoscopy to fix the rectum with sutures to the abdominal wall under needlescopic control. Further, investigators will evaluate the short and long-term clinical outcomes after this novel approach to treating rectal prolapse.

NCT ID: NCT01967446 Completed - Clinical trials for Pelvic Organ Prolapse

Predictors of Post Operative Morbidity in Older Women With Pelvic Organ Prolapse

Start date: March 2012
Phase: N/A
Study type: Observational

The Investigators hypothesize that functional status scores in elderly women undergoing surgery for pelvic organ prolapse will be lower at 6 weeks post-operatively but will have returned to baseline at 12 weeks post-operatively. The Investigators hypothesize that greater co-morbidity, frailty and worse functional status before surgery are associated with slower functional recovery, prolonged length of stay in a hospital or nursing care institution and greater post-operative complications following surgery for pelvic organ prolapse.