Safety Study of Pelvic Organ Prolapse Repair Using Transvaginal Mesh
NCT ID: NCT00402844
Last Updated: 2007-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2/PHASE3
250 participants
INTERVENTIONAL
2006-08-31
2007-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
\- 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.
Secondary objectives:
* 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).
Study design:
\- A prospective multicenter open labeled single cohort study.
Study protocol:
* 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Transvaginal mesh- PROLIFT®-system
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Symptoms related to pelvic organ prolapse including bulging, pelvic heaviness and vaginal protrusion
* Able to make an informed consent to participate
* Physically and mentally able to participate in follow-up
Exclusion Criteria
* Severe rheumatic disease requiring per oral steroid treatment
* Systemic connective tissue disorder (SLE, Sjögrens syndrome, Marfans syndrome, Ehlers Danhlos, collagenosis, polymyositis or polymyalgia rheumatica)
* Physically or mentally unable to participate in follow-up or give informed consent to participate in the study
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Karolinska University Hospital
OTHER
Karolinska Institutet
OTHER
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Daniel Altman, MD, PhD
Role: STUDY_CHAIR
Karolinska Institutet
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Nyköbing Hospital
Nyköbing, , Denmark
Skejby Hospital
Skejby, , Denmark
Jorvi Hospital
Jorvi, , Finland
Lahti Hospital
Lahti, , Finland
Lojo Hospital
Lohja, , Finland
Åbo Hospital
Turku, , Finland
Akershus University Hospital
Ahus, , Norway
Haukeland Hospital
Bergen, , Norway
Bærum Hospital
Bærum, , Norway
Gjøvik Hospital
Gjøvik, , Norway
Kongsberg Hospital
Kongsberg, , Norway
Rikshospitalet
Oslo, , Norway
The Regional Hospital in Tromsø
Tromsø, , Norway
Sahlgrenska Hospital
Gothenburg, , Sweden
Halmstad Hospital
Halmstad, , Sweden
Kristiansstad Hospital
Kristiansstad, , Sweden
Linköping University Hospital
Linköping, , Sweden
Vrinnevi Hospital
Norrköping, , Sweden
Örebro University Hospital
Örebro, , Sweden
Skaraborg Hospital Skövde
Skövde, , Sweden
Danderyd University Hospital
Stockholm, , Sweden
S:t Göran Hospital
Stockholm, , Sweden
South Hospital
Stockholm, , Sweden
Uppsala Academic Hospital
Uppsala, , Sweden
Västerås Hospital
Västerås, , Sweden
Ystad Hospital
Ystad, , Sweden
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Altman D, Falconer C. Perioperative morbidity using transvaginal mesh in pelvic organ prolapse repair. Obstet Gynecol. 2007 Feb;109(2 Pt 1):303-8. doi: 10.1097/01.AOG.0000250970.23128.63.
Elmer C, Falconer C, Hallin A, Larsson G, Ek M, Altman D; Nordic Transvaginal Mesh Group. Risk factors for mesh complications after trocar guided transvaginal mesh kit repair of anterior vaginal wall prolapse. Neurourol Urodyn. 2012 Sep;31(7):1165-9. doi: 10.1002/nau.22231. Epub 2012 Apr 19.
Altman D, Elmer C, Kiilholma P, Kinne I, Tegerstedt G, Falconer C; Nordic Transvaginal Mesh Group. Sexual dysfunction after trocar-guided transvaginal mesh repair of pelvic organ prolapse. Obstet Gynecol. 2009 Jan;113(1):127-133. doi: 10.1097/AOG.0b013e3181922362.
Elmer C, Altman D, Engh ME, Axelsen S, Vayrynen T, Falconer C; Nordic Transvaginal Mesh Group. Trocar-guided transvaginal mesh repair of pelvic organ prolapse. Obstet Gynecol. 2009 Jan;113(1):117-126. doi: 10.1097/AOG.0b013e3181922164.
Altman D, Vayrynen T, Engh ME, Axelsen S, Falconer C; Nordic Transvaginal Mesh Group. Short-term outcome after transvaginal mesh repair of pelvic organ prolapse. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Jun;19(6):787-93. doi: 10.1007/s00192-007-0526-2.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TVM-II-2006
Identifier Type: -
Identifier Source: org_study_id