Clinical trial NCT00566917: Comparison Between Transvaginal Mesh and Traditional Surgery for Pelvic Organ Prolapse
Official title: A Randomised Controlled Trial of Transvaginal Mesh (PROLIFT) Versus Anterior Colporrhaphy in Anterior Vaginal Wall Prolapse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vaginal Prolapse
Keywords: Vagina
Prolapse
Anterior vaginal wall prolapse
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: The regional agreement on medical training and clinical research (ALF) between Stockholm county council and Karolinska Institutet.
name: The Swedish Society of Medicine
name: Investigators meetings supported by Gynecare Scandinavia.
First posted: 2007-12-04
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.

Traditional surgical techniques are frequently associated with unsatisfying anatomical recurrence rates and 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. Over the years sporadic attempts have been made to introduce novel surgical techniques using a variety of biomaterials with varying success. Despite a lack of clinical safety data, or compelling clinical evidence demonstrating that it improves outcomes compared to traditional suture techniques, use of biomaterials in pelvic reconstructive surgery has become widespread in just a few years .

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. Short term data from concluded and on-going safety assessments of these techniques has provided promising results and satisfying clinical outcomes. The aim of the present study is to compare anterior mesh repair (PROLIFT®) with traditional suture repair in a randomised trial.


Eligibility criteria: Inclusion Criteria:

* Reproductive years in the past (biologically or reproductive decision)
* Prolapse of the anterior vaginal wall ≥POPQ-stadium II
* Prolapse specific pelvic symptom
* Being able to make an informed consent on participation
* Physically and cognitive capable of participating in the required follow-up
* No other pelvic floor surgery performed at the time of anterior repair
* No exclusion criteria fulfilled

Exclusion Criteria:

* Previous or current pelvic organ cancer (regardless of treatment)
* Severe rheumatic disease
* Insulin treated diabetes mellitus
* Connective tissue disorders (SLE, Sjögrens syndrome, Marfans syndrome, Ehlers Danhlos, collagenosis, polymyositis eller rheumatic myalgia)
* Current systemic steroid treatment

Primary outcomes:
measure: Combined primary outcome measure: anatomical assessment according to the pelvic organ prolapse quantification system and prolapse specific symptom
timeFrame: One year
Secondary outcomes:
measure: Quality of life
timeFrame: One year
Other outcomes:
Locations:
city: Nyköbing
country: Denmark
facility: Nyköbing Hospital
city: Skejby
country: Denmark
facility: Skejby Hospital
city: Hyvinkää
country: Finland
facility: Hyvinkää Hospital
city: Jorvi
country: Finland
facility: Jorvi Hospital
city: Jyväskylä
country: Finland
facility: Central Finland Central Finland
city: Kotka
country: Finland
facility: Central Finland Central Hospital
city: Lappeenranta
country: Finland
facility: South Carelian Central Hospital
city: Lojo
country: Finland
facility: Lohja Hospital
city: Porvoo
country: Finland
facility: Porvoo Hospital
city: Rovaniemi
country: Finland
facility: Lapland Central Hospital
city: Åbo
country: Finland
facility: Åbo Hospital
city: Ahus
country: Norway
facility: Akershus University Hospital
city: Bergen
country: Norway
facility: Haukeland Hospital
city: Brumunddal
country: Norway
facility: Innlandet Hospital
city: Bærum
country: Norway
facility: Bærum Hospital
city: Flekkefjord
country: Norway
facility: Sörlandet Hospital
city: Förde
country: Norway
facility: Förde Hospital
city: Hönefoss
country: Norway
facility: Ringerike Hospital
city: Kongsberg
country: Norway
facility: Kongsberg Hospital
city: Levanger
country: Norway
facility: Levanger Hospital
city: Namsos
country: Norway
facility: Namsos Hospital
city: Oslo
country: Norway
facility: Rikshospitalet
city: Skien
country: Norway
facility: Telemark Hospital
city: Stavanger
country: Norway
facility: Stavanger University Hospital
city: Tromsø
country: Norway
facility: The Regional Hospital in Tromsø
city: Trondheim
country: Norway
facility: St Olav Hospital
city: Borås
country: Sweden
facility: Borås Hospital
city: Eksjö
country: Sweden
facility: Höglandssjukhuset
city: Gothenburg
country: Sweden
facility: Sahlgrenska Hospital
city: Halmstad
country: Sweden
facility: Halmstad Hospital
city: Huddiksvall
country: Sweden
facility: Huddiksvall Hospital
city: Karlskoga
country: Sweden
facility: Karlskoga Hospital
city: Karlskrona
country: Sweden
facility: Karlskrona Hospital
city: Karlstad
country: Sweden
facility: Karlstad Hospital
city: Kristiansstad
country: Sweden
facility: Kristiansstad Hospital
city: Linköping
country: Sweden
facility: Linköping University Hospital
city: Luleå
country: Sweden
facility: Sunderby 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: Karolinska University Hospital Huddinge
city: Stockholm
country: Sweden
facility: S:t Göran Hospital
city: Stockholm
country: Sweden
facility: South Hospital
city: Sundsvall
country: Sweden
facility: Sundsvall Hospital
city: Södertälje
country: Sweden
facility: Södertälje Hospital
city: Trollhättan
country: Sweden
facility: NÄL Hospital
city: Uppsala
country: Sweden
facility: Uppsala Academic Hospital
city: Värnamo
country: Sweden
facility: Värnamo Hospital
city: Västervik
country: Sweden
facility: Västervik Hospital
city: Västerås
country: Sweden
facility: Västerås Hospital
city: Ystad
country: Sweden
facility: Ystad Hospital
city: Örebro
country: Sweden
facility: Capio Läkargruppen Örebro
city: Örebro
country: Sweden
facility: Örebro University Hospital
Study officials:
affiliation: Karolinska Institutet
name: Daniel Altman, MD, Assoc. prof.
role: STUDY_CHAIR
affiliation: Karolinska Institutet at Danderyd University Hospital
name: Christian Falconer, MD, Assoc. prof.
role: STUDY_DIRECTOR
affiliation: Karolinska Institutet
name: Daniel Altman, MD, Assoc. prof.
role: PRINCIPAL_INVESTIGATOR
References:
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, Vayrynen T, Engh ME, Axelsen S, Falconer C; Nordic Transvaginal Mesh Group. Anterior colporrhaphy versus transvaginal mesh for pelvic-organ prolapse. N Engl J Med. 2011 May 12;364(19):1826-36. doi: 10.1056/NEJMoa1009521.