300,000+ clinical trials. Find the right one.

85 active trials for Pelvic Organ Prolapse

Pelvic Floor Dysfunction and Its Influence on Body Image and Sexual Function

The first objective to determinate the prevalence of pelvic floor dysfunction in pregnant women and in the first year postpartum. The second objective is to assess the anatomical (both clinical and ultrasound), demographic and obstetric variables in symptomatic women and their association with pelvic floor dysfunction, sexual function and Body Image. This is a single center prospective cohort study. Women will be asked to fill out a questionnaire at the time of their 1st and 3rd trimester scan, at the postpartum checkup and 12 months postpartum. Furthermore, they will undergo a pelvic floor ultrasound at the time of their first and third trimester scan. The presence of pelvic floor dysfunctions will be recorded through validated self-administered questionnaires with five domains: Wexner questionnaire for anal incontinence, PAC-SYM for constipation, International Consultation on Incontinence Questionnaire Short Form for urinary incontinence, the Pelvic Organ Prolapse Distress Inventory for pelvic organ prolapse, POP/UI Sexual Questionnaire - IUGA revised for sexual function. The body image perception will be assessed using the Dutch-validated version of the self-administered Body Image Disturbance Questionnaire. The anatomy of the pelvic floor will be objectively assessed off line on 3D/4D transperineal ultrasound volumes and POP-Q examination. The demographic variables and information about the pregnancy and the delivery will be obtained from the medical records.

Start: August 2018

Prospective Assessment of Robotic Sacrocolpopexy: a European Multicentric Cohort (PARSEC)

The purpose of this study is to prospectively assess the outcomes of robotic sacrocolpopexy for repair of pelvic organ prolapse in high volume european centers.

Start: August 2011

The 3D Reconstruction Research of Pelvic Organ Prolapse Disease

Female pelvic organ prolapse (FPOP) is one of the main diseases affecting the quality of life of middle aged and elderly women in non-neoplastic diseases. An aging population makes the incidence of this disease to increase year by year. Surgical operation is the main treatment. While the recurrence rate of classic repair surgery is high, the method of patch implantation reinforces the supporting force, which significantly reduce the recurrence rate. However, this method is costly and is associated with complications which may trigger new symptoms. As such, there is still no perfect surgical method. The main reason for this is that the assessment method of pelvic defects is crude and indirect, which results in the diagnosis of FPOP only representing external problems whereas, inner defected parts are not properly assessed. In recent years, research with the use of 2D and 3D MRI reconstructions on the anus levator muscle and ligament has become a hot topic. It found that the characteristic of the high resolution of soft tissue in the magnetic resonance imaging (MRI) has a big advantage in pelvic floor study.The investigators commenced the study of 3D reconstruction technology based on the MRI datasets in 2009. The investigators have mastered the most common, key technologies of MRI three-dimensional reconstruction. The investigators have done research targeted on the reconstruction methods of the normal pelvis, viscera, ligaments, pelvic floor muscles. This project is aimed at 3D reconstruction of the whole pelvic base on static and dynamic MRI images from FPOP patients, and establish the corresponding space coordinates assessment system to do location and quantitative research of the pelvic viscera and its support structure, thus providing a FPOP diagnosis platform that is more precise, direct and comprehensive.

Start: September 2016

Comparison of the Efficacy of Sacrocolpopexy, the Amreich-Richter Procedure and Transvaginal Mesh

Pelvic organ prolapse, POP, is a common health problem affecting up to 40% of women. Very little is known about the factors associated with surgical failure. Studies have identified a variety of risk factors: younger age, high body mass index and advanced preoperative prolapse (grade III-IV) have been associated with an increased risk of reoperation in some studies. According to some studies patients had poorer anatomical outcome after traditional repairs but were able to enjoy the same quality of life as after transvaginal mesh surgery or laparoscopic sacrocolpopexy. The purpose of this study is to assess and compare the efficacy of these three procedures in a randomized controlled trial.

Start: September 2016

Advanced Genital Prolapse Surgery With and Without Mid Urethral Sling to Prevent Stress Urinary Incontinence

Pelvic organ prolapse (POP) is a public health problem worldwide, affecting about 30 %. It implies physical, psychological and social losses. A frequent complication after surgeries for POP is developing de novo stress urinary incontinence (SUI). SUI and POP have similar pathophysiology and therefore it is common to coexist in the same patient. De novo SUI has a prevalence 11-44 % after surgical correction of genital prolapse. Occult urinary incontinence (OUI) is considered the major risk factor for postoperative SUI. Studies on this topic show conflicting results. In a recent meta-analysis on this subject, Maher et al concluded that the value of performing any anti- incontinence procedure in continent women undergoing prolapse surgery remains unknown. The aims of this study are to evaluate whether the association of a transvaginal tape (TVT®) in continent patients undergoing surgery for prolapse decreases the risk of de novo SUI and if it implies an improvement in their quality of life. The secondary endpoints are to assess the complications associated with this procedure, as irritative symptoms and voiding dysfunction postoperatively and assessing the ability of stress testing with reduced POP and urodynamics in predicting the risk of de novo SUI. This study will be a prospective, multicentric, randomized experimental study. Patients with anterior or apical prolapse stages 3 and 4 (POP - Q) will be invited to participate in the study. The study will assess these patients for staging of prolapse, the presence of occult urinary incontinence and quality of life. Selected patients will be randomized to perform correction of genital prolapse and prophylactic anti-incontinence procedure or correction of genital prolapse only. Patients will be assessed 3, 6 and 12 months after surgery. Postoperative evaluation will be similar to preoperative. The exclusion criteria are: complaint or diagnosis of stress urinary incontinence before reduction of the prolapse, previous surgery for incontinence or pelvic organ prolapse, hypocontractility detrusor in urodynamics and inability to understand and give informed consent.

Start: February 2014