Safety Study of Pelvic Organ Prolapse Repair Using Transvaginal Mesh

Sponsor

Karolinska Institutet (Other)

Overall Status

Completed

CT.gov ID

NCT00402844

Collaborator

Karolinska University Hospital (Other)

250

Enrollment

Locations

Duration (Months)

9.6

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

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.

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2006

Actual Study Completion Date :

Mar 1, 2007

Outcome Measures

Primary Outcome Measures

Immediate and delayed TVM-related complications. [1 year]

Secondary Outcome Measures

Anatomical outcome using the validated POP-Q staging system. [1 year]
Subjective outcome using the validated UDI, IIQ and PISQ. [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country
1	Nyköbing Hospital	Nyköbing	Denmark
2	Skejby Hospital	Skejby	Denmark
3	Jorvi Hospital	Jorvi	Finland
4	Lahti Hospital	Lahti	Finland
5	Lojo Hospital	Lojo	Finland
6	Åbo Hospital	Åbo	Finland
7	Akershus University Hospital	Ahus	Norway
8	Haukeland Hospital	Bergen	Norway
9	Bærum Hospital	Bærum	Norway
10	Gjøvik Hospital	Gjøvik	Norway
11	Kongsberg Hospital	Kongsberg	Norway
12	Rikshospitalet	Oslo	Norway
13	The Regional Hospital in Tromsø	Tromsø	Norway
14	Sahlgrenska Hospital	Gothenburg	Sweden
15	Halmstad Hospital	Halmstad	Sweden
16	Kristiansstad Hospital	Kristiansstad	Sweden
17	Linköping University Hospital	Linköping	Sweden
18	Vrinnevi Hospital	Norrköping	Sweden
19	Skaraborg Hospital Skövde	Skövde	Sweden
20	Danderyd University Hospital	Stockholm	Sweden
21	S:t Göran Hospital	Stockholm	Sweden
22	South Hospital	Stockholm	Sweden
23	Uppsala Academic Hospital	Uppsala	Sweden
24	Västerås Hospital	Västerås	Sweden
25	Ystad Hospital	Ystad	Sweden
26	Örebro University Hospital	Örebro	Sweden