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

Peking Union Medical College Hospital · 2011
ClinicalTrials.gov · Datasets · License: Public Domain · 2011
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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.
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