Comparison Between Transvaginal Mesh and Traditional Surgery for Pelvic Organ Prolapse
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Vaginal Prolapse |
Procedure: Anterior colporrhaphy Procedure: Anterior PROLIFT |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | A Randomised Controlled Trial of Transvaginal Mesh (PROLIFT) Versus Anterior Colporrhaphy in Anterior Vaginal Wall Prolapse |
- Combined primary outcome measure: anatomical assessment according to the pelvic organ prolapse quantification system and prolapse specific symptom [ Time Frame: One year ] [ Designated as safety issue: No ]
- Quality of life [ Time Frame: One year ] [ Designated as safety issue: No ]
| Enrollment: | 400 |
| Study Start Date: | December 2007 |
| Study Completion Date: | January 2010 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Anterior colporrhaphy (standardised)
|
Procedure: Anterior colporrhaphy
Standardised colporrhaphy of the anterior vaginal wall
|
|
Experimental: 2
Anterior PROLIFT
|
Procedure: Anterior PROLIFT
Transvaginal mesh surgery of the anterior vaginal wall
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Show 53 Study Locations| Study Chair: | Daniel Altman, MD, Assoc. prof. | Karolinska Institutet |
| Study Director: | Christian Falconer, MD, Assoc. prof. | Karolinska Institutet at Danderyd University Hospital |
| Principal Investigator: | Daniel Altman, MD, Assoc. prof. | Karolinska Institutet |
More Information
No publications provided by Karolinska Institutet
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Associate professor Daniel Altman, MD, Karolinska Institutet |
| ClinicalTrials.gov Identifier: | NCT00566917 History of Changes |
| Other Study ID Numbers: | TVM III-07 |
| Study First Received: | November 30, 2007 |
| Last Updated: | January 28, 2010 |
| Health Authority: | Sweden: Swedish National Council on Medical Ethics |
Keywords provided by Karolinska Institutet:
|
Vagina Prolapse Anterior vaginal wall prolapse |
Additional relevant MeSH terms:
|
Prolapse Uterine Prolapse Pelvic Organ Prolapse |
Pathological Conditions, Anatomical Uterine Diseases Genital Diseases, Female |
ClinicalTrials.gov processed this record on May 16, 2013