Comparison Between Transvaginal Mesh and Traditional Surgery for Pelvic Organ Prolapse

This study has been completed.
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT00566917
First received: November 30, 2007
Last updated: January 28, 2010
Last verified: May 2008
  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

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

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 April 15, 2014