View clinical trials related to Prolapse.
Filter by:Optimal pelvic floor muscle function is known to assist bladder and bowel function and control, pelvic organ support, as well as other areas of health. It is also known that problems in some of tehse areas can be a consequence of pelvic surgery. By addressing the requirements for good bladder and bowel function/control, and organ support in the early post-surgery phase when tissue repair and scar formation are critical, it is proposed that there will be a rduction in the longterm prevalence of bladder problems, bowel difficulties and weakened pelvic floor and abdominal muscles in post-surgery patients. This study is a randomised controlled trial to compare patients undergoing a physiotherapy-supervised pelvic floor muscle training and behavioural therapy program with a control group. It is hypothesised that at the 12 month post-operative follow-up assessment, the treatment group will demonstrate better outcomes in bladder and bowel function and control, as well as stronger pelvic floor muscle contractile strength than the control group.
Pelvic floor prolapse is a general term used to describe various clinical conditions that are associated with pelvic floor (muscles that support the vagina) relaxation in female patients.Pelvic floor prolapse is thought to result from a stretching, weakening or tearing of the soft tissue structures that support the pelvic organs. These tissues become compromised because of a weakened or damaged.The purpose of the study will be to demonstrate the usability of Polypropylene Mesh for prolapse repair, using the TVM technique.
Prolapse of the uterus, bladder and rectum is a common condition in multiparous and/or elderly women. The number of operations for vaginal repair is increasing in Denmark, but there is no consensus or evidence found about the efficiency of prophylactic antibiotics intraoperatively concerning postoperative infections. The objective of this randomized, controlled trial is to investigate the significance of prophylactic antibiotic treatment in vaginal repair operations.
The purpose of this study is to investigate the feasibility of undertaking a multi-centre randomised controlled trial of the effectiveness of a pelvic floor muscle training (PFMT) intervention for women with pelvic organ prolapse.
Hypothesis / aims of study A RCT has shown that results of prolapse repair via vaginal approach could be improved when a polypropylene mesh is used as tissue support (1). However, non protected heavy-weight meshes were associated with a high rate of local complications such as vaginal erosions and dyspareunia (2). The aim of this multicentre study is to evaluate anatomical and functional results of an innovative low-weight polypropylene mesh protected by an absorbable hydrophilic film in the prolapse repair by vaginal route, in comparison by the standard anterior colporrhaphy. Study design, materials and methods This study involves 15 centres in French Private or Public Hospital. Patients will be randomly allocated to be operated by a standard anterior colporrhaphy or by an anterior repair reinforced by a specially designed mesh: UgytexTM (Sofradim, France). Ugytex is a low-weight (38g/m²) and highly porous (average porosity: 89%, pores over 1.5mm) polypropylene monofilament mesh offering tissue ingrowth and connective differentiation for a stable and long-term support. The mesh is coated with a hydrophilic film composed of atelocollagen, polyethylene glycol and glycerol. The absorbable coating protects delicate pelvic viscera from the risk of acute inflammation during the healing's inflammatory peak. 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 (3), as well as a validated questionnaire on sexual problems. The difference on one-year cure rate should be 15% (80% for the anterior colporrhaphy and 95% for the mesh repair). Then the estimated number of patient is 97 in each arm.
Hypothesis / 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.
The Colpopexy and Urinary Reduction Effort (CARE) trial is a research study designed to evaluate whether the addition of a second surgical procedure in addition to a procedure for female pelvic organ prolapse (POP) affects the rates of urinary incontinence. This study will follow women in the CARE study for 10 years from the time of the surgery to compare success and complication rates in the two groups. Recruitment into this study is open only to women that already participated in CARE. Recruitment into CARE is closed.
Pelvic organ prolapse occurs when the muscles holding pelvic organs (e.g., the uterus or bladder) weaken and the organs fall or slide down into the vagina. Pelvic organ prolapse can be corrected with surgery. However, women who have this surgery may develop urinary incontinence. This study will determine how doctors can predict this problem and whether an additional surgical procedure at the time of prolapse surgery can prevent the development of urinary incontinence.