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| Name | Class |
|---|---|
| The regional agreement on medical training and clinical research (ALF) between Stockholm county council and Karolinska Institutet. | UNKNOWN |
| The Swedish Society of Medicine | OTHER |
| Investigators meetings supported by Gynecare Scandinavia. |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Anterior colporrhaphy (standardised) |
|
| 2 | Experimental | Anterior PROLIFT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anterior colporrhaphy | Procedure | Standardised colporrhaphy of the anterior vaginal wall |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Combined primary outcome measure: anatomical assessment according to the pelvic organ prolapse quantification system and prolapse specific symptom | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | One year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Altman, MD, Assoc. prof. | Karolinska Institutet | Study Chair |
| Christian Falconer, MD, Assoc. prof. | Karolinska Institutet at Danderyd University Hospital | Study Director |
| Daniel Altman, MD, Assoc. prof. | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nyköbing Hospital | Nyköbing | Denmark | ||||
| Skejby Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42029168 | Derived | Christmann-Schmid C, Baessler K, Yeung E, Haya N, Mowat A, Chen Z, Wallace SA, Maher C. Surgery for women with anterior compartment prolapse. Cochrane Database Syst Rev. 2026 Apr 24;4(4):CD004014. doi: 10.1002/14651858.CD004014.pub7. | |
| 41649019 | Derived | Baessler K, Christmann-Schmid C, Haya N, Mowat A, Chen Z, Wallace SA, Yeung E, Maher C. Surgery for women with pelvic organ prolapse with or without stress urinary incontinence. Cochrane Database Syst Rev. 2026 Feb 6;2(2):CD013108. doi: 10.1002/14651858.CD013108.pub2. |
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| Anterior PROLIFT |
| Procedure |
Transvaginal mesh surgery of the anterior vaginal wall |
|
| Skejby |
| Denmark |
| Hyvinkää Hospital | Hyvinkää | Finland |
| Jorvi Hospital | Jorvi | Finland |
| Central Finland Central Finland | Jyväskylä | Finland |
| Central Finland Central Hospital | Kotka | Finland |
| South Carelian Central Hospital | Lappeenranta | Finland |
| Lohja Hospital | Lohja | Finland |
| Porvoo Hospital | Porvoo | Finland |
| Lapland Central Hospital | Rovaniemi | Finland |
| Åbo Hospital | Turku | Finland |
| Akershus University Hospital | Ahus | Norway |
| Haukeland Hospital | Bergen | Norway |
| Innlandet Hospital | Brumunddal | Norway |
| Bærum Hospital | Bærum | Norway |
| Sörlandet Hospital | Flekkefjord | Norway |
| Förde Hospital | Förde | Norway |
| Ringerike Hospital | Hönefoss | Norway |
| Kongsberg Hospital | Kongsberg | Norway |
| Levanger Hospital | Levanger | Norway |
| Namsos Hospital | Namsos | Norway |
| Rikshospitalet | Oslo | Norway |
| Telemark Hospital | Skien | Norway |
| Stavanger University Hospital | Stavanger | Norway |
| The Regional Hospital in Tromsø | Tromsø | Norway |
| St Olav Hospital | Trondheim | Norway |
| Borås Hospital | Borås | Sweden |
| Höglandssjukhuset | Eksjö | Sweden |
| Sahlgrenska Hospital | Gothenburg | Sweden |
| Halmstad Hospital | Halmstad | Sweden |
| Huddiksvall Hospital | Huddiksvall | Sweden |
| Karlskoga Hospital | Karlskoga | Sweden |
| Karlskrona Hospital | Karlskrona | Sweden |
| Karlstad Hospital | Karlstad | Sweden |
| Kristiansstad Hospital | Kristiansstad | Sweden |
| Linköping University Hospital | Linköping | Sweden |
| Sunderby Hospital | Luleå | Sweden |
| Vrinnevi Hospital | Norrköping | Sweden |
| Capio Läkargruppen Örebro | Örebro | Sweden |
| Örebro University Hospital | Örebro | Sweden |
| Skaraborg Hospital Skövde | Skövde | Sweden |
| Södertälje Hospital | Södertälje | Sweden |
| Danderyd University Hospital | Stockholm | Sweden |
| Karolinska University Hospital Huddinge | Stockholm | Sweden |
| S:t Göran Hospital | Stockholm | Sweden |
| South Hospital | Stockholm | Sweden |
| Sundsvall Hospital | Sundsvall | Sweden |
| NÄL Hospital | Trollhättan | Sweden |
| Uppsala Academic Hospital | Uppsala | Sweden |
| Värnamo Hospital | Värnamo | Sweden |
| Västerås Hospital | Västerås | Sweden |
| Västervik Hospital | Västervik | Sweden |
| Ystad Hospital | Ystad | Sweden |
| 38477494 | Derived | Yeung E, Baessler K, Christmann-Schmid C, Haya N, Chen Z, Wallace SA, Mowat A, Maher C. Transvaginal mesh or grafts or native tissue repair for vaginal prolapse. Cochrane Database Syst Rev. 2024 Mar 13;3(3):CD012079. doi: 10.1002/14651858.CD012079.pub2. |
| 37652301 | Derived | Simone CB 2nd, Serebrenik AA, Gore EM, Mohindra P, Brown SL, Wang D, Chetty IJ, Vujaskovic Z, Menon S, Thompson J, Fine G, Kaytor MD, Movsas B. Multicenter Phase 1b/2a Clinical Trial of Radioprotectant BIO 300 Oral Suspension for Patients With Non-Small Cell Lung Cancer Receiving Concurrent Chemoradiotherapy. Int J Radiat Oncol Biol Phys. 2024 Feb 1;118(2):404-414. doi: 10.1016/j.ijrobp.2023.08.048. Epub 2023 Aug 29. |
| 22517125 | Derived | 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. |
| 21561348 | Derived | 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. |
| ID | Term |
|---|---|
| D014596 | Uterine Prolapse |
| D011391 | Prolapse |
| ID | Term |
|---|---|
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D056887 | Pelvic Organ Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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