Safety Study of Pelvic Organ Prolapse Repair Using Transvaginal Mesh

Pelvic Organ Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00402844
• Other study ID #: TVM-II-2006
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 20, 2006
• Last updated: November 13, 2007
• Start date: August 2006
• Est. completion date: March 2007

Study information

• Verified date: November 2007
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Swedish National Council on Medical Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Device:
• Transvaginal mesh- PROLIFT®-system

Locations

Country	Name	City	State
Denmark	Nyköbing Hospital	Nyköbing
Denmark	Skejby Hospital	Skejby
Finland	Åbo Hospital	Åbo
Finland	Jorvi Hospital	Jorvi
Finland	Lahti Hospital	Lahti
Finland	Lojo Hospital	Lojo
Norway	Akershus University Hospital	Ahus
Norway	Bærum Hospital	Bærum
Norway	Haukeland Hospital	Bergen
Norway	Gjøvik Hospital	Gjøvik
Norway	Kongsberg Hospital	Kongsberg
Norway	Rikshospitalet	Oslo
Norway	The Regional Hospital in Tromsø	Tromsø
Sweden	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

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Karolinska University Hospital

Countries where clinical trial is conducted

Denmark,  Finland,  Norway,  Sweden, 

References & Publications (1)

Altman D, Falconer C. Perioperative morbidity using transvaginal mesh in pelvic organ prolapse repair. Obstet Gynecol. 2007 Feb;109(2 Pt 1):303-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immediate and delayed TVM-related complications.		1 year
Secondary	Anatomical outcome using the validated POP-Q staging system.		1 year
Secondary	Subjective outcome using the validated UDI, IIQ and PISQ.		1 year