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Comparison Between Transvaginal Mesh and Traditional Surgery for Pelvic Organ Prolapse

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00566917
First Posted: December 4, 2007
Last Update Posted: January 29, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
The regional agreement on medical training and clinical research (ALF) between Stockholm county council and Karolinska Institutet.
The Swedish Society of Medicine
Investigators meetings supported by Gynecare Scandinavia.
Information provided by:
Karolinska Institutet
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial of Transvaginal Mesh (PROLIFT) Versus Anterior Colporrhaphy in Anterior Vaginal Wall Prolapse

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Combined primary outcome measure: anatomical assessment according to the pelvic organ prolapse quantification system and prolapse specific symptom [ Time Frame: One year ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: One year ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00566917


  Show 53 Study Locations
Sponsors and Collaborators
Karolinska Institutet
The regional agreement on medical training and clinical research (ALF) between Stockholm county council and Karolinska Institutet.
The Swedish Society of Medicine
Investigators meetings supported by Gynecare Scandinavia.
Investigators
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

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
First Submitted: November 30, 2007
First Posted: December 4, 2007
Last Update Posted: January 29, 2010
Last Verified: May 2008

Keywords provided by Karolinska Institutet:
Vagina
Prolapse
Anterior vaginal wall prolapse

Additional relevant MeSH terms:
Prolapse
Pelvic Organ Prolapse
Uterine Prolapse
Pathological Conditions, Anatomical
Uterine Diseases
Genital Diseases, Female