Safety Study of Pelvic Organ Prolapse Repair Using Transvaginal Mesh - Full Text View

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 II Phase III

MedlinePlus related topics:

Anatomy Pelvic Support Problems

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title:	A Multicenter Clinical Safety Assessment of Polypropylene Transvaginal Mesh in Pelvic Reconstructive Surgery

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

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

Locations


Denmark
	Skejby Hospital
	Skejby, Denmark
	Nyköbing Hospital
	Nyköbing, Denmark

Finland
	Jorvi Hospital
	Jorvi, Finland
	Lahti Hospital
	Lahti, Finland
	Åbo Hospital
	Åbo, Finland
	Lojo Hospital
	Lojo, Finland

Norway
	Gjøvik Hospital
	Gjøvik, Norway
	Rikshospitalet
	Oslo, Norway
	Haukeland Hospital
	Bergen, Norway
	Bærum Hospital
	Bærum, Norway
	The Regional Hospital in Tromsø
	Tromsø, Norway
	Akershus University Hospital
	Ahus, Norway
	Kongsberg Hospital
	Kongsberg, Norway

Sweden
	Danderyd University Hospital
	Stockholm, Sweden
	South Hospital
	Stockholm, Sweden
	Sahlgrenska Hospital
	Gothenburg, Sweden
	S:t Göran Hospital
	Stockholm, Sweden
	Västerås Hospital
	Västerås, Sweden
	Ystad Hospital
	Ystad, Sweden
	Skaraborg Hospital Skövde
	Skövde, Sweden
	Vrinnevi Hospital
	Norrköping, Sweden
	Linköping University Hospital
	Linköping, Sweden
	Kristiansstad Hospital
	Kristiansstad, Sweden
	Örebro University Hospital
	Örebro, Sweden
	Halmstad Hospital
	Halmstad, Sweden
	Uppsala Academic Hospital
	Uppsala, Sweden

Sponsors and Collaborators

Karolinska Institutet

Karolinska University Hospital

Investigators


Study Chair:	Daniel Altman, MD, PhD	Karolinska Institutet, Stockholm, Sweden

More Information

Publications indexed to this study:

Altman D, Väyrynen 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.

Study ID Numbers:	TVM-II-2006
First Received:	November 20, 2006
Last Updated:	November 13, 2007
ClinicalTrials.gov Identifier:	NCT00402844
Health Authority:	Sweden: Swedish National Council on Medical Ethics

Keywords provided by Karolinska Institutet:

Multicenter

Pelvic organ prolapse

Prospective

Transvaginal mesh

Study placed in the following topic categories:

Pathological Conditions, Anatomical

Digestive System Diseases

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Prolapse

Rectal Prolapse

ClinicalTrials.gov processed this record on October 03, 2008

Sponsors and Collaborators:	Karolinska Institutet Karolinska University Hospital
Information provided by:	Karolinska Institutet
ClinicalTrials.gov Identifier:	NCT00402844