Safety and Performance of the EndoFast Reliant SCP in Vaginal Wall Reinforcement
Pelvic Organ ProlapseA Single arm, single site, retrospective cohort Post Marketing Clinical Follow up Study Evaluating the Safety and Performance of the EndoFast Reliant SCP for apical support.
Video Decision Aid in Latina Women With Pelvic Organ Prolapse
Pelvic Organ ProlapsePelvic organ prolapse (POP) is a highly prevalent condition among women that impairs quality of life, daily activities and sexual function. Latina women are disproportionally affected, with significantly higher rates of POP compared to women of other ethnicities. Decision aids have been used to increase patient knowledge prior to physician intervention and to facilitate informed patient participation on treatment selection. The investigators hypothesize that the use of a video decision aid prior to initial Urogynecology specialist evaluation of Latina women with POP in a border region university-affiliated medical clinic, will increase patient knowledge regarding the condition, decrease decisional conflict regarding selection among different treatment options and increase patient satisfaction with selected treatment.
ProViS (Prolift+M and Vita Sexualis) Study
Pelvic Organ ProlapseTransvaginal 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.
Validation of Transvaginal Tactile Imaging
Pelvic Organ ProlapseThe purpose of this study is to validate safety and effectiveness in assessment of the female pelvic floor tissue, and, assess the ability of Vaginal Tactile Imager (VTI) to detect early prolapse conditions and characterize the outcome of reconstructive surgery.
Sacro-Spinous Ligaments Anterior Apical Anchoring
Pelvic Organ ProlapseAnterior-apical compartment mesh implants for pelvic floor reconstruction are anchored here to the Sacro-Spinous ligaments and evaluated being a feasible and effective method.
Interactive Web-Based Tool for Pelvic Organ Prolapse: Impact on Patient Understanding and Provider...
Pelvic Organ ProlapseThe primary aim is to assess whether an interactive patient/provider counseling process using a web-based tool (iPadTM) will improve patient satisfaction regarding understanding of her bulge symptoms. The secondary aims are to assess whether an interactive patient/provider counseling process using web-based tool (iPadTM) will: Decrease patient anxiety with counseling Improve patient satisfaction with counseling Improve provider knowledge, anxiety, and satisfaction with counseling Be easy to use in clinic Be actually used in clinic
A Surgical Simulation Study to Evaluate the Safety of a Device Mechanism as Treatment for Vaginal...
Pelvic Organ ProlapseThe purpose of this pilot study is to perform a procedure to evaluate the safety of the placement of a new device (known as the VFIX device).
Robotic-assisted Laparoscopic Sacrocolpopexy
Pelvic Organ ProlapseRobotic-assisted Abdominal Sacrocolpopexy is both a feasible and safe method for apical prolapse repair of the vagina.
Composite Graft Use in Abdominal Sacrocolpopexy Reduces Erosion Rates
Pelvic Organ ProlapseThis study is to determine whether the use of a composite biologic/synthetic graft during abdominal sacrocolpopexy leads to a lower rate of erosion while maintaining durability.
Posterior IVS Versus Sacrospinous Suspension in Vaginal Vault Prolapse Repair
Vaginal ProlapseHypothesis / aims of study The aim of this multicentre study is to evaluate anatomical and functional results of an innovative posterior tape in vaginal prolapse repair by vaginal route, in comparison to the sacrospinous suspension. Study design, materials and methods This study involves 5 centres in French Public Hospital. Patients will be randomly allocated to be operated by a sacrospinous suspension or by an posterior IVSTM (Tyco Healthcare, France). Prolapse severity will be evaluated using the POP-Q system. In order to evaluate the patient's quality of life, the validated PFDI and the PFIQ questionnaires will be used preoperatively and during follow-up, as well as a validated questionnaire on sexual problems. The difference on early post-operative pain should be 30% (40% for the sacrospinous suspension and 10% for the posterior IVS). Then the estimated number of patient is 40 in each arm.