Efficacy and Safety of Reduced Pelvic Floor Mesh Implants
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01739374|
Recruitment Status : Completed
First Posted : December 3, 2012
Last Update Posted : June 18, 2015
|Condition or disease||Intervention/treatment||Phase|
|Post Operative Pain Complication of Surgical Procedure||Other: reduced mesh implants||Phase 2 Phase 3|
Pelvic organ prolapse is a common disorder that results in significant patient morbidity. Approximately 1 in 9 women undergo surgery for the correction of pelvic organ prolapse (POP) and associated bladder and bowel dysfunction. Despite its common occurrence, the cause of POP remains largely unknown. Prolapse is thought to be caused by direct injury to the levator ani (LA) muscle, denervation of the pelvic floor musculature, or fascial damage incurred during childbirth trauma.
It is evident that pelvic organ prolapse (POP) occurs when the supporting pelvic floor becomes weakened or stretched, usually caused by childbirth, leading to descent of the pelvic organs to the vagina and beyond. This contributes to the impairment of pelvic organ function and a deterioration of patient quality of life. POP is estimated to severely affect approximately 11% of the female population.
Symptomatic POP patients might benefit from conservative management, such as the use of physiotherapy or vaginal pessaries. However, advanced POP necessitates surgical reconstruction. This might be achieved by the abdominal approach by an open operation or by laparoscopy, or by the vaginal approach. Synthetic permanent or absorbable meshes or biological grafts, or any synthesis of these might be used for reinforcement of the weakened pelvic floor structures that led to POP.
The need for reinforcement of the weakened fascia for achieving a long lasting cure of herniation processes is un-questionable. Given that the underlying pathology leading to POP is actually just a hernia of the pelvic floor, one must admit that the very same surgical principles used for any hernia repair are applicable for POP.
Most of the adverse effects are related to excessive implanted mesh mass. Thus, our goal with this study is to look at the issue of reducing the mesh size, surface area and the total mesh mass, assuming that the less quantity of left over implant the less mesh related complication will occur. The narrative for that is the notion that the natural pelvic floor connective tissue architecture is ligamentary and not "sheath like", while available pre-cut meshes are much too wide spread. This study concept is that reducing the mesh surface will lead to reduction with the mesh related complication. Given that the mesh implant size will be reduced, so will also be the wide of the extent of preliminary dissection, necessary for proper mesh placement. Thus, the dissection related adverse effects are expected to reduce as well.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 2-3 Study of Efficacy and Safety of Reduced Pelvic Floor Mesh Implants|
|Study Start Date :||May 2013|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||March 2015|
Experimental: Device - Reduced mesh implants
Patients treated with reduced mesh implants for POP reconstruction
Other: reduced mesh implants
mesh for pelvic floor reinforcement
- Intra-operative and post operative adverse effects [ Time Frame: One year post operative ]Vaginal and pelvic pain upon VAS, vaginal mesh exposure, infections.
- Efficacy [ Time Frame: One year ]Pelvic organ prolapse reconstruction upon the International Continence Society Pelvic Organ Prolapse Quantification System measurements
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): NCT01739374
|Western Galilee MC|
|Nahariya, Israel, 22110|
|Ob-Gyn Dep., Western Galilee MC|
|Nahariya, Israel, 65742|
|Principal Investigator:||Menahem Neuman, Prof.||Faculty of Medicine, Bar-Ilan Univ., Zafed|