Clinical trial NCT00402844: Safety Study of Pelvic Organ Prolapse Repair Using Transvaginal Mesh
Official title: A Multicenter Clinical Safety Assessment of Polypropylene Transvaginal Mesh in Pelvic Reconstructive Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Pelvic Organ Prolapse
Keywords: Multicenter
Pelvic organ prolapse
Prospective
Transvaginal mesh
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Karolinska University Hospital
First posted: 2006-11-22
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Immediate and delayed TVM-related complications.
timeFrame: 1 year
Secondary outcomes:
measure: Anatomical outcome using the validated POP-Q staging system.
timeFrame: 1 year
measure: Subjective outcome using the validated UDI, IIQ and PISQ.
timeFrame: 1 year
Other outcomes:
Locations:
city: Nyköbing
country: Denmark
facility: Nyköbing Hospital
city: Skejby
country: Denmark
facility: Skejby Hospital
city: Jorvi
country: Finland
facility: Jorvi Hospital
city: Lahti
country: Finland
facility: Lahti Hospital
city: Lojo
country: Finland
facility: Lojo Hospital
city: Åbo
country: Finland
facility: Åbo Hospital
city: Ahus
country: Norway
facility: Akershus University Hospital
city: Bergen
country: Norway
facility: Haukeland Hospital
city: Bærum
country: Norway
facility: Bærum Hospital
city: Gjøvik
country: Norway
facility: Gjøvik Hospital
city: Kongsberg
country: Norway
facility: Kongsberg Hospital
city: Oslo
country: Norway
facility: Rikshospitalet
city: Tromsø
country: Norway
facility: The Regional Hospital in Tromsø
city: Gothenburg
country: Sweden
facility: Sahlgrenska Hospital
city: Halmstad
country: Sweden
facility: Halmstad Hospital
city: Kristiansstad
country: Sweden
facility: Kristiansstad Hospital
city: Linköping
country: Sweden
facility: Linköping University Hospital
city: Norrköping
country: Sweden
facility: Vrinnevi Hospital
city: Skövde
country: Sweden
facility: Skaraborg Hospital Skövde
city: Stockholm
country: Sweden
facility: Danderyd University Hospital
city: Stockholm
country: Sweden
facility: S:t Göran Hospital
city: Stockholm
country: Sweden
facility: South Hospital
city: Uppsala
country: Sweden
facility: Uppsala Academic Hospital
city: Västerås
country: Sweden
facility: Västerås Hospital
city: Ystad
country: Sweden
facility: Ystad Hospital
city: Örebro
country: Sweden
facility: Örebro University Hospital
Study officials:
affiliation: Karolinska Institutet
name: Daniel Altman, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.