Safety Study of Pelvic Organ Prolapse Repair Using Transvaginal Mesh
|ClinicalTrials.gov Identifier: NCT00402844|
Recruitment Status : Completed
First Posted : November 22, 2006
Last Update Posted : November 14, 2007
Pelvic organ prolapse is characterized by a lack of pelvic floor support causing the pelvic organs and vaginal walls to protrude. For decades, suture repair techniques have been the primary choice of surgical treatment when indicated.
The notion of reinforcing pelvic floor defects using biomaterial implants is not an exclusively contemporary idea. Traditional surgical techniques are frequently associated with unsatisfying anatomical recurrence rates and over the years sporadic attempts have been made to introduce novel surgical techniques using a variety of biomaterials as support with varying success. It is plausible that inherently weak, or damaged, pelvic floor supportive tissues need to be reinforced by a permanent support to avoid the high rates of recurrences commonly described using traditional techniques. However, use of biomaterials in pelvic reconstructive surgery has become widespread in just a few years despite a lack of clinical safety data, or compelling clinical evidence demonstrating that it improves outcomes compared to traditional suture techniques.
It is likely that biomaterials need to be "anchored" in tissues not afflicted by the disease, in order to provide the intended pelvic floor support. This has given rise to transvaginal surgical techniques using a transobturator approach passing the mesh through the arcus tendineous fascia pelvis, or the sacrospinous ligaments through a transgluteal approach. Already commercially available implant materials are in need of patient safety documentation, both when considering the surgical techniques by which these materials are placed in the body as well as the actual materials. Complication rates and perioperative morbidity using these surgical routes in pelvic organ prolapse surgery are generally unknown.
The aim of the present study was to assess the long term morbidity, and describe the complications, associated with transvaginal mesh repair of pelvic organ prolapse using the PROLIFT®-system.
|Condition or disease||Intervention/treatment||Phase|
|Pelvic Organ Prolapse||Device: Transvaginal mesh- PROLIFT®-system||Phase 2 Phase 3|
- To describe short and long-term complications associated with pelvic organ prolapse repair using macroporous polypropylene transvaginal mesh (TVM) using a transobturator or transgluteal approach.
- To describe anatomical restoration of the pelvic floor following transvaginal mesh repair of pelvic organ prolapse using the Pelvic Organ Prolapse Quantification system (POP-Q).
- To describe subjective patient outcomes using validated questionnaires with regard to pelvic organ function (UDI), sexual function (PISQ) and quality of life (IIQ).
- A prospective multicenter open labeled single cohort study.
- At baseline patients receive oral and written information about the study.
- Following informed consent, patients are included in the study if pelvic organ prolapse surgery is indicated and all inclusion, and no exclusion, criteria are fulfilled.
- Preoperatively all patients answer a detailed self reported questionnaire on health history, previous surgery, obstetrical history and current diseases and medications. The questionnaire also includes questions on symptoms from the pelvic organs and pelvic floor.
- Preoperatively all patients undergo a clinical examination using the POP-Q system, as well as, a validated clinical inflammatory grading of the vaginal compartments.
- Patients undergo the TVM procedure in a standardised manner with all participating surgeons having undergone pretrial surgical training and adopting the same surgical technique. All patients receive standardised intraoperative antibiotics.
- Complications during the immediate peri- and postoperative hospital stay are registered in hospital charts.
- All patients receive a clinical follow-up appointment 2 months, 1 year and 3 years after surgery. At follow-up identical self reported questionnaires are used for subjective assessment. Clinical examinations are performed as preoperatively suing the POP-Q system and macroscopic inflammatory grading. Complications are registered in a specific protocol and hospital charts.
- All protocols are to be submitted after the 2 months follow-up for an interrim safety analysis. The study chair is responsible for stopping the study if the rate, or seriousness, of complications exceed the expected.
- Patients are free to withdraw from the study at any point.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter Clinical Safety Assessment of Polypropylene Transvaginal Mesh in Pelvic Reconstructive Surgery|
|Study Start Date :||August 2006|
|Study Completion Date :||March 2007|
- Immediate and delayed TVM-related complications. [ Time Frame: 1 year ]
- Anatomical outcome using the validated POP-Q staging system. [ Time Frame: 1 year ]
- Subjective outcome using the validated UDI, IIQ and PISQ. [ Time Frame: 1 year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00402844
|Akershus University Hospital|
|The Regional Hospital in Tromsø|
|Linköping University Hospital|
|Skaraborg Hospital Skövde|
|Danderyd University Hospital|
|S:t Göran Hospital|
|Uppsala Academic Hospital|
|Örebro University Hospital|
|Study Chair:||Daniel Altman, MD, PhD||Karolinska Institutet, Stockholm, Sweden|