NCT00402844

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. The notion of reinforcing pelvic floor defects using biomaterial implants is not an exclusively contemporary idea. Traditional surgical techniques are frequently associated with unsatisfying anatomical recurrence rates and over the years sporadic attempts have been made to introduce novel surgical techniques using a variety of biomaterials as support with varying success. 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. However, use of biomaterials in pelvic reconstructive surgery has become widespread in just a few years despite a lack of clinical safety data, or compelling clinical evidence demonstrating that it improves outcomes compared to traditional suture techniques. 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. Already commercially available implant materials are in need of patient safety documentation, both when considering the surgical techniques by which these materials are placed in the body as well as the actual materials. Complication rates and perioperative morbidity using these surgical routes in pelvic organ prolapse surgery are generally unknown. The aim of the present study was to assess the long term morbidity, and describe the complications, associated with transvaginal mesh repair of pelvic organ prolapse using the PROLIFT®-system.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2006

Shorter than P25 for phase_2

Geographic Reach
4 countries

26 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 22, 2006

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

November 14, 2007

Status Verified

November 1, 2007

First QC Date

November 20, 2006

Last Update Submit

November 13, 2007

Conditions

Pelvic Organ Prolapse

Keywords

MulticenterPelvic organ prolapseProspectiveTransvaginal mesh

Outcome Measures

Primary Outcomes (1)

  • Immediate and delayed TVM-related complications.

    1 year

Secondary Outcomes (2)

  • Anatomical outcome using the validated POP-Q staging system.

    1 year

  • Subjective outcome using the validated UDI, IIQ and PISQ.

    1 year

Interventions

Transvaginal mesh- PROLIFT®-systemDEVICE

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pelvic organ prolapse stage 2 or more according to the POP-Q staging system
  • Symptoms related to pelvic organ prolapse including bulging, pelvic heaviness and vaginal protrusion
  • Able to make an informed consent to participate
  • Physically and mentally able to participate in follow-up

You may not qualify if:

  • Previous pelvic organ cancer regardless of treatment
  • Severe rheumatic disease requiring per oral steroid treatment
  • Systemic connective tissue disorder (SLE, Sjögrens syndrome, Marfans syndrome, Ehlers Danhlos, collagenosis, polymyositis or polymyalgia rheumatica)
  • Physically or mentally unable to participate in follow-up or give informed consent to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

Nyköbing Hospital

Nyköbing, Denmark

Location

Skejby Hospital

Skejby, Denmark

Location

Jorvi Hospital

Jorvi, Finland

Location

Lahti Hospital

Lahti, Finland

Location

Lojo Hospital

Lohja, Finland

Location

Åbo Hospital

Turku, Finland

Location

Akershus University Hospital

Ahus, Norway

Location

Haukeland Hospital

Bergen, Norway

Location

Bærum Hospital

Bærum, Norway

Location

Gjøvik Hospital

Gjøvik, Norway

Location

Kongsberg Hospital

Kongsberg, Norway

Location

Rikshospitalet

Oslo, Norway

Location

The Regional Hospital in Tromsø

Tromsø, Norway

Location

Sahlgrenska Hospital

Gothenburg, Sweden

Location

Halmstad Hospital

Halmstad, Sweden

Location

Kristiansstad Hospital

Kristiansstad, Sweden

Location

Linköping University Hospital

Linköping, Sweden

Location

Vrinnevi Hospital

Norrköping, Sweden

Location

Örebro University Hospital

Örebro, Sweden

Location

Skaraborg Hospital Skövde

Skövde, Sweden

Location

Danderyd University Hospital

Stockholm, Sweden

Location

S:t Göran Hospital

Stockholm, Sweden

Location

South Hospital

Stockholm, Sweden

Location

Uppsala Academic Hospital

Uppsala, Sweden

Location

Västerås Hospital

Västerås, Sweden

Location

Ystad Hospital

Ystad, Sweden

Location

Related Publications (5)

  • Altman D, Falconer C. Perioperative morbidity using transvaginal mesh in pelvic organ prolapse repair. Obstet Gynecol. 2007 Feb;109(2 Pt 1):303-8. doi: 10.1097/01.AOG.0000250970.23128.63.

    PMID: 17267828BACKGROUND

  • 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.

    PMID: 22517125DERIVED

  • Altman D, Elmer C, Kiilholma P, Kinne I, Tegerstedt G, Falconer C; Nordic Transvaginal Mesh Group. Sexual dysfunction after trocar-guided transvaginal mesh repair of pelvic organ prolapse. Obstet Gynecol. 2009 Jan;113(1):127-133. doi: 10.1097/AOG.0b013e3181922362.

    PMID: 19104368DERIVED

  • Elmer C, Altman D, Engh ME, Axelsen S, Vayrynen T, Falconer C; Nordic Transvaginal Mesh Group. Trocar-guided transvaginal mesh repair of pelvic organ prolapse. Obstet Gynecol. 2009 Jan;113(1):117-126. doi: 10.1097/AOG.0b013e3181922164.

    PMID: 19104367DERIVED

  • Altman D, Vayrynen T, Engh ME, Axelsen S, Falconer C; Nordic Transvaginal Mesh Group. Short-term outcome after transvaginal mesh repair of pelvic organ prolapse. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Jun;19(6):787-93. doi: 10.1007/s00192-007-0526-2.

    PMID: 18074068DERIVED

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Daniel Altman, MD, PhD

    Karolinska Institutet

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 20, 2006

First Posted

November 22, 2006

Study Start

August 1, 2006

Study Completion

March 1, 2007

Last Updated

November 14, 2007

Record last verified: 2007-11

Locations

DK(2)SE(13)FI(4)NO(7)