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Prolapse clinical trials

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NCT ID: NCT01762384 Recruiting - Uterine Prolapse Clinical Trials

Laparoscopic Sacral Colpopexy Versus Modified Total Pelvic Floor Reconstructive Surgery for Apical Prolapse Stage III-IV

Start date: December 2012
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. Sacral Colpopexy is the gold standard procedure. Now it could be done laparoscopically. Modified total pelvic floor reconstructive surgery with mesh is developed in China for Asian Women. This study is designed to determine the effectiveness and safety of Modified total pelvic floor reconstructive surgery with mesh compared with laparoscopic Sacral Colpopexy for the treatment of uterine or vault prolapse Stage III-IV. 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: NCT01760603 Recruiting - Clinical trials for Pelvic Organ Prolapse

Ischia Spinous Fascia Fixation Surgery for Pelvic Organ Prolapse

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

Pelvic organ prolapse is a common problem. The primary treatment is surgery. Ischia spinous fascia fixation procedure is developed in China for vaginal apex fixation with native tissue. This study is designed to determine the effectiveness and safety of ischia spinous fascia fixation procedure for the treatment of pelvic organ prolapse stage III. 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: NCT01719211 Recruiting - Clinical trials for Mitral Valve Prolapse

Genetic Basis of Mitral Valve Prolapse

MVP
Start date: January 1999
Phase:
Study type: Observational

The investigators have successfully identified two novel genetic loci for MVP on chromosomes 11 and 13 and are searching for altered genes in these regions. This requires recruiting large families who may have MVP linked to these or other chromosomes; and obtaining DNA samples from 1,000-1,500 individually affected patients to study the relation between DNA markers throughout the genome and MVP. It is our expectation that the results of this study will lead to the discovery of gene(s) responsible for MVP. This will lead to improved understanding of the disease and, in turn, improved ability to treat and prevent progression in genetically susceptible individuals.

NCT ID: NCT01670682 Recruiting - Clinical trials for Pelvic Organ Prolapse

Ischia Spinous Fascia Fixation Procedure Versus Modified Total Pelvic Floor Reconstructive Surgery for Pelvic Organ Prolapse Stage III

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

Pelvic organ prolapse is a common problem. The primary treatment is surgery. Ischia spinous fascia fixation procedure and modified total pelvic floor reconstructive surgery with mesh are both developed in China for vaginal apex fixation, the former is native tissue repairs, and the latter is augmentation with mesh. This study is designed to determine the effectiveness and safety of ischia spinous fascia fixation procedure compared with modified total pelvic floor reconstructive surgery with mesh for the treatment of pelvic organ prolapse stage III. 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: NCT01648751 Recruiting - Clinical trials for Pelvic Organ Prolapse

Vaginal Estrogen and Pelvic Floor Physical Therapy in Women With Symptomatic Mild Prolapse

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

This is a randomized controlled trial in which women with symptomatic mild pelvic organ prolapse undergoing Pelvic Floor Physical Therapy (PFPT) receive vaginal estrogen versus placebo to see if a combined approach to treatment leads to improvement in clinical outcomes. The investigators predict that PFPT in combination with vaginal estrogen will lead to decreased pelvic floor symptoms and improved anatomical support corroborated by biomarker data.

NCT ID: NCT01608568 Recruiting - Prolapse Clinical Trials

Affixing Polypropylene Mesh Using Barbed Suture (Quill™ SRS) During Robotic Assisted Laparoscopic Sacrocolpopexy

Quill RALSC
Start date: November 2010
Phase: N/A
Study type: Interventional

1.0 STUDY OBJECTIVE 1.1 PRIMARY OBJECTIVE - To compare two methods of polypropylene mesh attachment during robotic assisted laparoscopic sacrocolpopexy (RALSC): running technique using self-anchoring 1 barbed delayed absorbable suture (Quill™ SRS, Angiotech Pharmaceuticals, Inc. Vancouver, Canada) versus interrupted technique using 0 non-barbed delayed absorbable suture (PDS II™, Ethicon, Somerville, NJ, USA). 1.2 SECONDARY OBJECTIVE - To compare robotic assisted laparoscopic sacrocolpopexy anatomic failure rates at 6 months post-operative follow-up using self-anchoring 1 barbed delayed absorbable suture (Quill™ SRS, Angiotech Pharmaceuticals, Inc. Vancouver, Canada) versus 0 non-barbed delayed absorbable suture (PDS II™, Ethicon, Somerville, NJ, USA). The investigators will also assess mesh erosion rates, costs, and surgeon satisfaction rates. 2.0 HYPOTHESIS 2.1 Primary: 2.1.a. Attachment of mesh using the running technique with self-anchoring 1 barbed delayed absorbable suture (Quill™ SRS, Angiotech Pharmaceuticals, Inc. Vancouver, Canada) will be faster than the standard fixation interrupted technique using 0 non-barbed delayed absorbable suture (PDS II™, Ethicon, Somerville, NJ, USA). 2.2 Secondary: 2.2.a. Attachment of mesh using the running technique with self-anchoring 1 barbed delayed absorbable suture (Quill™ SRS, Angiotech Pharmaceuticals, Inc. Vancouver, Canada) will be less costly than the standard fixation interrupted technique using 0 non-barbed delayed absorbable suture (PDS II™, Ethicon, Somerville, NJ, USA). 2.2.b. Failure rates and mesh erosion rates for each technique will be equally low. 2.2.c. Surgeons will prefer the barbed running technique over the interrupted technique based on subjective surgeon satisfaction questionnaires.

NCT ID: NCT01598467 Recruiting - Clinical trials for Pelvic Organ Prolapse

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

PARSEC
Start date: August 2011
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT01540214 Recruiting - Clinical trials for Pelvic Organ Prolapse

Study of Overactive Bladder in Women With Prolapse

SOAP
Start date: February 2012
Phase: N/A
Study type: Observational

Pelvic organ prolapse (POP) is a common problem. Symptoms of overactive bladder (OAB) are present in approximately 50% of patients with POP. For many women the accompanying symptoms of OAB are an important reason for seeking help for their POP. Surgical repair of prolapse may improve OAB complaints. Persisting or de novo OAB symptoms are strongly correlated with dissatisfaction with the final results of an operation for POP. The primary aim of this research project is to investigate the difference in prevalence (i.e. improvement) of OAB and bothersome OAB symptoms at 6 and 12 months after POP repair surgery. The secondary objectives are to determine changes in bladder function at 6 and 12 months after surgery and to identify predictive factors for persistence, disappearance or de novo symptoms of OAB after POP surgery. Women who present with POP and who will undergo surgical treatment will be evaluated at baseline before their surgery and will be followed for the duration of one year after surgery.

NCT ID: NCT01535833 Recruiting - Clinical trials for Pelvic Organ Prolapse

Robotic Assisted Sacral Colpopexy : A Prospective Study Assessing Outcomes With Learning Curves

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

The investigators scientific aims are to determine the benefits associated with the use of robotic assisted laparoscopic sacrocolpopexy surgery on women with prolapse, to define how the benefits impact the patient, physician and the institution, and to determine the complications associated with the use of the robot. This will be a prospective cohort following 100 patients for a 24 month period.

NCT ID: NCT01524107 Recruiting - Clinical trials for Urgent Caesarian Section Secondary to Cord Prolapse

Complications: Urgent C Section VS Elective C Section

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

The medical literature does not provide sufficient information or recommendation regarding specific antibiotic coverage for urgent Caesarian sections. The goal of this study is to compare maternal and neonatal morbidity of women who have undergone urgent Caesarian Sections for Prolapsed Cord to those who have undergone Elective Caesarian Sections in order to develop a standard treatment protocol. The Medical Record review will include many parameters including complications, type of antibiotic usage etc.