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Prolapse clinical trials

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NCT ID: NCT01518296 Recruiting - Clinical trials for Patients With Pelvic Organs Prolapse

Rating Pelvic Organs Prolapse in Women According to the POPQ Method Before and After Emptying the Urinary Bladder

Start date: January 2012
Phase: N/A
Study type: Interventional

Pelvic organ prolapse is a common disorder that affects 3-9% of adult women. Treatment of this disorder varies and includes conservative and interventional treatment. Pelvic organs prolapse grading has an important roll in determining the appropriate treatment. Developments in this field has led to the development of an agreed method to rate the degree of pelvic organs prolapse (POPQ). The roll of Urodynamic test is to assess whether there is urinary incontinence and underlying cause. In Richard C. et al publication, that presented the Pelvic Organ Prolapse Quantification (POPQ) method for the first time, there was no reference to the urinary bladder state (full or empty) during the examination, hence the investigators are asking to conduct a prospective study in order to evaluate the degree of pelvic organs prolapse according to POPQ method during urodynamic examination, with a full and empty urinary bladder.

NCT ID: NCT01396122 Recruiting - Clinical trials for Pelvic Organ Prolapse

Clinical Performance of GYNECARE PROSIMA* Pelvic Floor Repair System for Symptomatic Pelvic Organ Prolapse

Start date: March 2011
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the safety and effectiveness of the GYNECARE PROSIMA* Pelvic Floor Repair System as a Device in Women with Symptomatic Pelvic Organ Prolapse.

NCT ID: NCT01396109 Recruiting - Uterine Prolapse Clinical Trials

GYNECARE PROSIMA* Procedure Versus Modified Total Pelvic Floor Reconstructive Surgery for Uterine Prolapse Stage III

Start date: March 2011
Phase: N/A
Study type: Interventional

Pelvic Organ prolapse (a feeling of bulge in the vagina) may cause some distressing symptoms such as loss of control of the bowel or bladder, and may also cause problems with patient's sex life. The primary treatment is surgery, sometimes a mesh is placed in the pelvis to support the weakened tissues, but mesh implants can cause complications. This study is designed to determine the effectiveness and safety of GYNECARE PROSIMA* pelvic floor repair system compared with the modified total pelvic floor reconstructive surgery with mesh for the treatment of uterine prolapse. Patients enrolled into the study will be followed up for up to 3 years after surgery. Evaluation will take place during surgery and postoperative visit. Stage of prolapse before and after surgery, patient satisfaction through quality of life and sexual function questionnaires before and after surgery, and peri-operative complication rates will be evaluated.

NCT ID: NCT01346436 Recruiting - Clinical trials for Pelvic Organ Prolapse

Value of Robotic Rectopexy for the Treatment of Complex Pelvic Floor Dysfunction

Start date: April 2011
Phase: Phase 4
Study type: Interventional

The purpose of this randomized double blind controlled study is to assess the value of robotics for the treatment of complex pelvic floor dysfunction. The main aim is to compare perioperative and functional outcomes to the laparoscopic approach.

NCT ID: NCT00928239 Recruiting - Clinical trials for Vaginal Vault Prolapse

Laparoscopic Sacropexy: Comparison of Mesh Attachment

MeshPlace
Start date: June 2009
Phase: N/A
Study type: Interventional

The purpose of this study is to compare postoperative complications and outcome two different attachment sites of the dorsal mesh support in laparoscopic sacropexy.

NCT ID: NCT00918099 Recruiting - Vaginal Prolapse Clinical Trials

The Use of Avaulta for Anterior Repair

Start date: October 2008
Phase: N/A
Study type: Interventional

Summary: Vaginal prolapse is a well-known disease and is observed in approximately 11% of all postmenopausal women and tending to increase with age. Consequently, many surgical procedures have been developed in order to ensure sufficient support for the bladder, rectum or vaginal vault depending on the site of the defect. However, many procedures are associated with a high recurrence rate up to 40 % even within one to two years after the surgical procedure. Due to the high recurrence rate new methods include the use of mesh, either biologically or synthetic. The latter is a permanent implant and therefore theoretically may result in a long-lasting anatomically correct position of the prolapse. Although the recurrence rate may be lower using a mesh such surgical procedures may be associated with adverse events such as erosions of the vaginal mucosa. Others have observed shrinkage of the vaginal mucosa. However, in these studies large prolene mesh have been used. In contrast the recurrence rate is lowered up to 25%. The above-mentioned advantage of synthetic mesh is however, mostly based on few non-randomised studies. The investigators therefore find it of importance to evaluate whether a surgical procedure using a mesh implant is superior to conventional surgical techniques. The present study is a clinical controlled study where patients with anterior vaginal prolapse are randomised to either a mesh technique or a standard anterior procedure. The present study includes only two more visits at the outpatient clinic after the surgical procedure. Furthermore the patients have to fulfil questionnaires regarding urinary and faecal leakage and sexual habits. Any participation in the study is totally voluntary and the patient may at any time withdraw herself. In any case the patient will receive the investigators' standard treatment.

NCT ID: NCT00886223 Recruiting - Clinical trials for Vaginal Vault Prolapse

Laparoscopic Sacropexy With Robot-Assisted Surgical System

RobPex
Start date: April 2009
Phase: N/A
Study type: Interventional

The aim of the study is to evaluate safety and outcome of robot-assisted laparoscopic sacropexy regarding perioperative data, objective anatomical results and postoperative quality of life.

NCT ID: NCT00836680 Recruiting - Clinical trials for Internal Rectal Prolapse

Clinical Study for the Evaluation of the Efficiency of a Device for the Diagnosis of an Internal Rectal Prolapse, a Pelvic Floor Ptosis and for the Determination of an Internal Hernia Into the Douglas Pouch

Start date: January 2009
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if the device is supplying sufficient diagnosis results of an internal rectal prolapse, of a pelvic floor ptosis and for the determination of an interal hernia into the Douglas pouch, as well as to determine the technical success of using the device at the patient.

NCT ID: NCT00695240 Recruiting - Clinical trials for Pelvic Organ Prolapse

Post-Operative Pain Control Using Direct Continuous Bupivacaine Infusion After Pelvic Organ Prolapse Repair

Start date: April 2007
Phase: Phase 2/Phase 3
Study type: Interventional

This prospective randomized controlled study will determine the efficacy of continuous local anesthesia at decreasing pain scores compared to patient controlled analgesia for pelvic organ prolapse procedures including posterior colporrhaphy and sacrospinous ligament fixation.

NCT ID: NCT00572702 Recruiting - Clinical trials for Pelvic Organ Prolapse

Randomized,Multicentric Study to Treat Prolapse After Hysterectomy With Amreich Procedure or Total Prolift Procedure

Start date: January 2007
Phase: N/A
Study type: Interventional

Head to Head comparison of perioperative complications and secondary the impact of operation techniques with or without mesh on patients suffering from pelvic organ prolapse on quality of life.