View clinical trials related to Prolapse.
Filter by:The purpose of this study is to evaluate the efficacy, recurrence, postoperative complications of partially absorbable mesh(Seratom®PA) in patients with pelvic organ prolapse.
The investigators aim is to augment the current process for surgical consent for patients undergoing urogynecological procedures by incorporating visual media. We propose that visual media will be an effective and efficient addition to the standard of care in urogynecological consents and will improve patient understanding and satisfaction. Our randomized controlled trial will investigate the effect of standardizing the consent for three urogynecologic procedures (vaginal hysterectomy, robotic sacrocolpopexy, and sub-urethral sling) using visual media, on patients' understanding of, and satisfaction with, their procedure. Our primary outcome will be patient's knowledge score at the end of the pre-operative clinic visit, and secondary outcomes include patients' satisfaction, subjective understanding of their procedure, immediate pre-operative and post-operative knowledge, and number of post-operative encounters. Participants will be followed up to their post-operative clinic visit.
The clinical study includes investigation of the outcomes of surgery for biomechanical restoration of pelvic floor conditions, monitoring pelvic floor conditions under conservative treatment/management, identification and investigation changes of pelvic floor muscle contractions and their significance in characterization of pelvic floor conditions, assessment of tactile imaging reproducibility, including pelvic floor muscle contraction.
The study is carried out at the Sahlgrenska University Hospital and the patient population consists of women referred with symptomatic and bothersome post-hysterectomy vaginal vault prolapse at least 1 cm above or beyond the hymeneal remnants. The interventions are either vaginal sacrospinousfixation or laparoscopic sacrocolpopexy following randomization to one of the types of surgery. The primary outcome is anatomical failure based on clinical assessment. Failure is defined clinically, according to the Pelvic Organ Prolapse Quantification system, as Ba, C or Bp at the hymen or below on maximum Valsalva maneuver one and two years after the surgery. Secondary outcomes are evaluation of continence, sexual function and prolapse symptoms based on validated questionnaires 1, 2, 5 and 10 years after the surgery.
The main purpose of the feasibility study is to identify the patient experience of Femmeze® which is a device aimed at improving posterior vaginal compartment prolapse (rectocele) for women with obstructive defaecation. The investigators want to investigate implementation and preliminary effectiveness of the device. The method of investigation will be a pre-post intervention design, which involves asking 30 women to use Femmeze® over a period of 8 weeks. This is an academic study on a labelled indication (http://www.nres.nhs.uk/search/?q=medical+devices).
Primary Aim: The primary aim of this randomized controlled trial (RCT) is to compare vaginal mesh and suture exposure rates in women undergoing robotic total hysterectomy and sacrocolpopexy with a light-weight polypropylene mesh (Upsylon™ y-mesh) using permanent (polytetrafluoroethylene, Gore-Tex) versus delayed absorbable monofilament (2-0 polydioxanone, PDS) sutures through 1-year. Secondary Aims: 1. To compare the 1-year composite success rate (leading edge of prolapse is at or above the hymen and apex has descended less than 1/3 of the vaginal length, no subjective feeling of bulge; and no retreatment for pelvic organ prolapse (POP) or vaginal mesh exposure) of permanent versus delayed absorbable sutures for mesh graft attachment during robotic total hysterectomy and sacrocolpopexy. 2. To evaluate adverse outcomes in each group
Compare operative times and complications of sacral colpopexy and paravaginal repair between two-dimensional and three-dimensional laparoscopic systems.
The purpose of the study is to determine the clinical cure rates of pelvic organ prolapse from subjects that had a robotic-assisted sacrocolpopexy using Alyte Y mesh and Restorelle Y smartmesh lightweight mesh.
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).
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.