View clinical trials related to Pelvic Organ Prolapse.
Filter by: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).
The study includes five (5) main stages: Screening, Enrollment, Size fitting, Usage and Termination. Subject screening will be held during visit one (1) and visit two (2) at the clinic. Initiation and Size fitting: All eligible subjects will undergo size fitting by a gynecologist / urogynecologist, during visit 2, to find the suitable size for her. The subject will use the ProVATE device of the chosen size at the clinic vicinity for about one (1) hour and for 40-80 hours at her home environment, to confirm that the chosen size is appropriate for the user. Each usage will be followed by a vaginal examination. In case the investigator will determine that the subject should be fitted with a different size of the ProVATE device the subject will repeat this stage with a different device size until the suitable size is confirmed by the investigator. Usage: The subject will use the ProVATE device for at least 28 days during a 45 days period, at her home environment, and fill a usage diary. Each device will be used for at least 24 hours. At least one (1) follow-up phone call will be held with the subject per a week. After 14 usage days or following at least two (2) usages (the latest of them) the subject will be scheduled for vaginal examination at the clinic (visit four (4)). End Of Use At the end of use the subject will return to the clinic (visit five (5)) for a vaginal examination and additional activities. The following questionnaires will be filled at baseline and end of study: Quality Of Life (QoL) and POP symptoms. Satisfaction and Ease Of Use questionnaires will be filled at the end of use (visit 5) Up to four (4) ProVATE device models will be tested in this study.
Pelvic organ prolapse is highly prevalent in the female population. The recurrence rate of pelvic organ prolapse after surgical treatment is high. This emphasizes the clinical need for improvement of the surgical techniques currently used. Placement of a mesh aims at reducing the recurrence rate. In this study the investigators compare the effectiveness of the Tension free Vaginal mesh + Monocryl with standard vaginal prolapse surgery without mesh.
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.
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
1. To evaluate whether a standardized tension-free vaginal tape-obturator(TVT-O) procedure, when added to a planned improved reconstruction pelvic surgery, improves the rate of urinary stress continence in subjects with occult stress incontinence. 2. Observe the immediate and short-term complications, overall urinary tract function, and other aspects of pelvic health between subjects with and without a TVT-O procedure.