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Prolapse clinical trials

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NCT ID: NCT00420225 Completed - Clinical trials for Anterior Vaginal Wall Prolapse

Mesh Repair of Anterior Vaginal Wall Prolapse

Start date: April 2003
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether reenforcement with polypropylen mesh compared with traditional anterior colporrhaphy for anterior vaginal wall prolapse results in fewer recurrences.

NCT ID: NCT00402844 Completed - Clinical trials for Pelvic Organ Prolapse

Safety Study of Pelvic Organ Prolapse Repair Using Transvaginal Mesh

Start date: August 2006
Phase: Phase 2/Phase 3
Study type: Interventional

Pelvic organ prolapse is characterized by a lack of pelvic floor support causing the pelvic organs and vaginal walls to protrude. For decades, suture repair techniques have been the primary choice of surgical treatment when indicated. The notion of reinforcing pelvic floor defects using biomaterial implants is not an exclusively contemporary idea. Traditional surgical techniques are frequently associated with unsatisfying anatomical recurrence rates and over the years sporadic attempts have been made to introduce novel surgical techniques using a variety of biomaterials as support with varying success. It is plausible that inherently weak, or damaged, pelvic floor supportive tissues need to be reinforced by a permanent support to avoid the high rates of recurrences commonly described using traditional techniques. However, use of biomaterials in pelvic reconstructive surgery has become widespread in just a few years despite a lack of clinical safety data, or compelling clinical evidence demonstrating that it improves outcomes compared to traditional suture techniques. It is likely that biomaterials need to be "anchored" in tissues not afflicted by the disease, in order to provide the intended pelvic floor support. This has given rise to transvaginal surgical techniques using a transobturator approach passing the mesh through the arcus tendineous fascia pelvis, or the sacrospinous ligaments through a transgluteal approach. Already commercially available implant materials are in need of patient safety documentation, both when considering the surgical techniques by which these materials are placed in the body as well as the actual materials. Complication rates and perioperative morbidity using these surgical routes in pelvic organ prolapse surgery are generally unknown. The aim of the present study was to assess the long term morbidity, and describe the complications, associated with transvaginal mesh repair of pelvic organ prolapse using the PROLIFT®-system.

NCT ID: NCT00388947 Completed - Vaginal Prolapse Clinical Trials

Observational Data Collection of Surgical Outcomes in the Treatment of Vaginal Prolapse With AMS Products

POWER1012
Start date: September 2006
Phase: N/A
Study type: Observational

This registry was observational (only collected information typically noted by the surgeon when their patients were routinely seen); there was no change to the care the patient received as a result of being part of the registry). Data collection focused on the surgical outcomes of AMS prolapse products.

NCT ID: NCT00353704 Completed - Clinical trials for Intervertebral Disk Displacement

Analgetic and Anxiolytic Effect of Preoperative Pregabalin

Start date: November 2005
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine whether the use of oral pregabalin 150 mg as premedication reduces the amount and degree of postoperative pain. Furthermore the purpose of this study is to determine whether the use of oral pregabalin 150 mg as premedication reduces anxiety prior to anaesthesia in these patients.

NCT ID: NCT00308009 Completed - Clinical trials for Pelvic Organ Prolapse

Comparison of the Result of TVT Performed at the Time of Prolapse Surgery or 3 Months After

Start date: February 2002
Phase: N/A
Study type: Interventional

It is unknown whether it is best to do the TVT( procedure for urinary stress incontinence in women) at the time of prolapse surgery or at a later date. Women with both conditions were randomized to both procedures together or the TVT 3 months after the prolapse surgery. Any or no leakage when couching was the main end-point, evaluated 1 year after the last surgery

NCT ID: NCT00271297 Completed - Cystocele Clinical Trials

Pelvic Floor Muscle Training (PFMT) in Treatment and Prevention of POP (POP Study)

Start date: December 2005
Phase: N/A
Study type: Interventional

Background: The pelvic floor muscles (PFM) are located inside the pelvis, surrounding the urethra, vagina and rectum. They provide structural support for the pelvic organs. Dysfunctional PFM can lead to urine and fecal incontinence, pelvic organ prolapse (POP), sexual problems and chronic pain syndromes. POP increases with age, parity and weakness in the PFM. Symptoms associated with POP are backache, bladder, bowel and sexual dysfunction, and pelvic heaviness. Thus the condition is debilitating and can greatly affect the quality of life, interfering with day-to-day activities and reduce participation in physical activity. The aim of the project: As life expectancy increases, more women may experience POP. Hence it is important to prevent and treat the condition at an early stage. Despite being a common disorder among women, little research has been done on POP. The aim of this study is to evaluate the effect of pelvic floor muscle training (PFMT). PFMT is a non-invasive method with no adverse effects. If there is significant effect, the main goal is to incorporate this method in clinical practice among physiotherapists and medical doctors. If PFM training is effective, more emphasis of PFM training can be put into regular female fitness programs. The prevalence of POP increases with age. Method: This is a single blind randomised controlled trial to evaluate the effect of PFMT on POP. 100 women with POP will be randomised to either training or control group. The training programme will last for six months, training once a week with a physiotherapist in addition to a structured home training programme. A blinded case-control study will also be carried out. 50 women without POP will be matched for age and vaginal deliveries. Before starting the RCT study, a reproducibility study on perineal ultrasound will be carried out in 18 women.

NCT ID: NCT00271102 Completed - Prolapse Clinical Trials

Surgical Study Comparing 2 Procedures for the Treatment of a Dropped Bladder

Start date: January 2006
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether vaginal repair or abdominal repair is the procedure of choice for the surgical management of a prolapsed bladder.

NCT ID: NCT00271037 Completed - Clinical trials for Pelvic Organ Prolapse

Colpocleisis for Advanced Pelvic Organ Prolapse

Start date: July 2004
Phase: N/A
Study type: Observational

Pelvic organ prolapse occurs when the pelvic organs (e.g., the uterus or bladder) fall or slide down into the vagina. Pelvic organ prolapse can be corrected with surgery. Some types of surgery try to restore the normal anatomy and function of the vagina (i.e., reconstructive surgery). Other surgery repairs the prolapse by essentially closing the vagina (e.g., colpocleisis or colpectomy), thereby leaving a woman unable to have vaginal intercourse in the future. The use of colpocleisis has not been well-studied. The current literature is lacking sufficient studies of colpocleisis to fully understand its risks and benefits for women considering surgery for prolapse. Traditionally, colpocleisis has been restricted to elderly women thought to be poor medical risks for prolonged reconstructive surgery. This study will describe the postoperative course of women who undergo colpocleisis, with particular attention to the persistence or recurrence of urinary incontinence and patient satisfaction after the colpocleisis prolapse surgery.

NCT ID: NCT00223106 Completed - Clinical trials for Urinary Incontinence, Stress

Treatment for Stress and Mixed Urinary Incontinence and Vaginal Vault Prolapse

Start date: March 2004
Phase: N/A
Study type: Interventional

The primary objective of this study is to further evaluate the safety and effectiveness of the use of a sling device in women for stress and mixed urinary incontinence as well as vaginal vault prolapse.

NCT ID: NCT00222326 Completed - Clinical trials for Vaginal Hysterectomy

The Effect of Physiotherapy Treatment Following Gynaecological Surgery

Start date: July 2002
Phase: N/A
Study type: Interventional

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.