Comparison Between Two Types of Meshes Used in Pelvic Organs Prolapse Procedures
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|ClinicalTrials.gov Identifier: NCT01645020|
Recruitment Status : Unknown
Verified July 2012 by Western Galilee Hospital-Nahariya.
Recruitment status was: Recruiting
First Posted : July 19, 2012
Last Update Posted : July 19, 2012
|Condition or disease|
Weakness of pelvic floor support is the cause defects and damage to pelvic organs functioning and urinary control and it has a pretty common occurrence. It was suggested recently that the event is considered a hernia that requires mesh use, which reduces return rates following pelvic floor repair. Mesh use is known to cause complications and unwanted side effects, such as chronic pain, vaginal network exposure and infection. The degree of complications is related directly to the mass of the mesh, and that's why the absorbable meshes were developed.Two months after the surgery with absorbable mesh, the mass left in the patient's body is half of the initial mesh mass and according to our assumption this effect will minimize the extent and intensity of mesh complications compared with conventional ones.
During the study we will examine medical records of women who have had surgery with pelvic floor reconstructive meshes. The cases will be divided according to the mesh type being used.
A polypropylene mesh (single strand and tunneling wide) trade name "Prolift", and similar mesh that contains approximately half of the network mass after being dissolves in two months, a trade name "Prolift +" M.
The number of participants in each group is 120 women. The post-operative follow-up examination will include three points in time. After a month, six months and a year later. In addition to questionnaires in order to quantify the degree of urinary disturbance, pain after surgery and sexual function.
|Study Type :||Observational|
|Estimated Enrollment :||240 participants|
|Observational Model:||Case Control|
|Official Title:||Comparison Between Two Types of Meshes Used in Pelvic Organs Prolapse Procedures|
|Study Start Date :||August 2008|
|Estimated Primary Completion Date :||January 2013|
|Estimated Study Completion Date :||June 2013|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01645020
|Contact: M Neuman, MD||972 3 956 email@example.com|
|Contact: R sawaid, MD||972 4 956 firstname.lastname@example.org|
|Western Galilee Hospital||Recruiting|
|Nahariya, Israel, 22100|
|Principal Investigator:||M Neuman, MD|
|Principal Investigator:||Menahem Neuman|