Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Safety Study of Pelvic Organ Prolapse Repair Using Transvaginal Mesh

This study has been completed.
Sponsor:
Collaborator:
Karolinska University Hospital
Information provided by:
Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT00402844
First received: November 20, 2006
Last updated: November 13, 2007
Last verified: November 2007
  Purpose

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 Intervention Phase
Pelvic Organ Prolapse
Device: Transvaginal mesh- PROLIFT®-system
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter Clinical Safety Assessment of Polypropylene Transvaginal Mesh in Pelvic Reconstructive Surgery

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Immediate and delayed TVM-related complications. [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 250
Study Start Date: August 2006
Study Completion Date: March 2007
Detailed Description:

Main objective:

- 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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pelvic organ prolapse stage 2 or more according to the POP-Q staging system
  • 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:

  • Previous pelvic organ cancer regardless of treatment
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00402844

Locations
Denmark
Nyköbing Hospital
Nyköbing, Denmark
Skejby Hospital
Skejby, Denmark
Finland
Jorvi Hospital
Jorvi, Finland
Lahti Hospital
Lahti, Finland
Lojo Hospital
Lojo, Finland
Åbo Hospital
Åbo, Finland
Norway
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
Sweden
Sahlgrenska Hospital
Gothenburg, Sweden
Halmstad Hospital
Halmstad, Sweden
Kristiansstad Hospital
Kristiansstad, Sweden
Linköping University Hospital
Linköping, Sweden
Vrinnevi Hospital
Norrköping, 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
Örebro University Hospital
Örebro, Sweden
Sponsors and Collaborators
Karolinska Institutet
Karolinska University Hospital
Investigators
Study Chair: Daniel Altman, MD, PhD Karolinska Institutet, Stockholm, Sweden
  More Information

No publications provided by Karolinska Institutet

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00402844     History of Changes
Other Study ID Numbers: TVM-II-2006
Study First Received: November 20, 2006
Last Updated: November 13, 2007
Health Authority: Sweden: Swedish National Council on Medical Ethics

Keywords provided by Karolinska Institutet:
Multicenter
Pelvic organ prolapse
Prospective
Transvaginal mesh

Additional relevant MeSH terms:
Pelvic Organ Prolapse
Prolapse
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on November 20, 2014