VROUW2: Effectiveness Prolift+M Versus Conventional Vaginal Prolapse Surgery

Sponsor
Radboud University Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT02231099
Collaborator
(none)
176
5
2
56
35.2
0.6

Study Details

Study Description

Brief Summary

Pelvic organ prolapse is highly prevalent in the female population. The recurrence rate of pelvic organ prolapse after surgical treatment is high. This emphasizes the clinical need for improvement of the surgical techniques currently used. Placement of a mesh aims at reducing the recurrence rate.

In this study the investigators compare the effectiveness of the Tension free Vaginal mesh + Monocryl with standard vaginal prolapse surgery without mesh.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Prolift + M
  • Procedure: conventional vaginal prolapse surgery
N/A

Detailed Description

Rationale: Pelvic organ prolapse is highly prevalent in the female population. The incidence of pelvic organ prolapse increases with age, so the longer life expectancy of women may cause pelvic organ prolapse to become an even more major health issue. The recurrence rate of pelvic organ prolapse after surgical treatment is high. The recurrence rate of the anterior vaginal wall prolapse after an anterior colporrhaphy is 30%-45%. The posterior vaginal wall prolapse recurrence rate after a posterior colporrhaphy is 12-25%. This emphasizes the clinical need for improvement of the surgical techniques currently used. Placement of a mesh aims at reducing the recurrence rate (2-11%).

Objective: To compare the clinical and cost effectiveness of the Tension free Vaginal Mesh + Monocryl (Prolift+M) with the standard vaginal prolapse surgery (i.e. fascial placation). A secondary objective is to track the post-operative and long-term complications of both procedures. A third objective is to evaluate recovery after surgery.

Study design: a prospective, multicentre, randomized, non-blinded study between Tension free Vaginal Mesh + Monocryl (Prolift+MTM) and standard vaginal prolapse surgery (i.e. fascial placation).

Study population: women with a primary pelvic organ prolapse of the anterior and/or posterior compartment POP stage II or more, in the age of 45 years or older.

Intervention (if applicable): Prolapse surgery with tension free vaginal mesh + Monocryl (Prolift + M) versus conventional vaginal prolapse surgery.

Main study parameters/endpoints: The main outcome is the percentage of patients with objective anatomical success (POP stage < 2) after 24 months. As secondary outcome the subjective improvement in quality of life will be measured by generic (EQ-5D,PGI-I) and disease-specific (UDI, DDI, IIQ and PFDI20) quality of life instrument. Sexual functioning will be measured by generic (FSFI) and disease specific (PISQ12) questionnaires. Complications will be monitored with special notice for pain (Mc Gill pain questionnaire) Recovery will be measured with the Recovery index 10. The economical endpoint is short term (2 year) incremental cost-effectiveness in terms of costs per additional year free of prolapse and costs per QALY gained.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Burden associated with participation: complete a disease specific Quality of life questionnaire 4 times, complete a recovery index questionnaire 3 times. Visit the hospital 4 times after the surgery (this is 2 times more often than patients not participating in the study). Since subjects are selected from subjects already agreeing to complete a surgical procedure, the additional risks of participation in this study are low. These risks include tissue erosion (vaginal, rectal or bladder), vaginal pain/dyspareunia.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
176 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Prospective and Comparative Study of the (Cost)Effectiveness Preformance of Tension Free Vaginal Mesh Plus Monocryl (Prolift+M) Versus Conventional Vaginal Prolaps Surgery in Primary Pelvic Organ Prolapse
Study Start Date :
Jan 1, 2011
Anticipated Primary Completion Date :
Sep 1, 2015
Anticipated Study Completion Date :
Sep 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: prolift + m

surgery with mesh (prolift+M)

Procedure: Prolift + M
prolapse surgery with mesh

Active Comparator: conventional vaginal prolapse surgery

conventional vaginal prolapse surgery; anterior colporrhaphy or posterior colporrhaphy or spinal ligament fixation

Procedure: conventional vaginal prolapse surgery
conventional vaginal prolapse surgery;anterior colporrhaphy, posterior colporrhaphy
Other Names:
  • anterior colporrhaphy, posterior colporrhaphy
  • Outcome Measures

    Primary Outcome Measures

    1. objective anatomic success (POPQ stage <2) [24 months]

      clinical investigation including POPQ

    Secondary Outcome Measures

    1. subjective improvement in quality of life [24 months]

      Questionnaires; Euroqol5D, PGI-I, UDI, DDI and PFDI20

    2. sexual function/dysfunction [24 months]

      PISQ-12, BESAQ

    3. complications [24 months]

      clinical investigation

    4. recovery [6 weeks]

      Recovery Index 10

    5. cost-effectiveness [24 months]

      Costs of the strategies Tension free Vaginal mesh+Monocryl as well as standard vaginal prolapse surgery will be estimated using direct medical costs based on the actual costs of the surgery, personnel, material costs and costs for surgery due to recurrence or complications.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Subject has a anterior and/or posterior prolapse POP-Q stage II or more. Subjects with a middle compartment prolapse may only be included if there is a co-existing anterior or posterior defect which needs surgical correction.

    • Subject has agreed to undergo implantation of Prolift+MTM or fascial plication

    • Subject is willing to return for follow-up evaluation and QoL questionnaires completion at 6weeks, 6 months, 12 months and 24 months follow-ups.

    Exclusion Criteria:
    • Pregnancy

    • Age < 45 years

    • Subject has had a previous surgery for pelvic organ prolapse. A previous mid-urethral sling procedure is not an exclusion criterion.

    • Have current urinary tract or vaginal infections

    • Have blood coagulation disorders

    • Have a compromised immune system or any other conditions that would compromise healing

    • Are unwilling or unable to return for evaluation

    • Previous irradiation

    • Presence of any malignancy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Gelre ziekenhuizen Apeldoorn Apeldoorn Netherlands
    2 Reinier de Graaf Group Delft Netherlands 2625 AD
    3 UMC St Radboud Nijmegen Netherlands 6500 HB
    4 Zaans Medisch Centre Zaandam Netherlands 1500 EE
    5 Isala clinics Zwolle Netherlands 8025 AB

    Sponsors and Collaborators

    • Radboud University Medical Center

    Investigators

    • Principal Investigator: Mariella IJ Withagen, MD, PhD, Radboud Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mariella Withagen, Dr. M.I.J. Withagen, Radboud University Medical Center
    ClinicalTrials.gov Identifier:
    NCT02231099
    Other Study ID Numbers:
    • VROUW2
    First Posted:
    Sep 4, 2014
    Last Update Posted:
    Feb 6, 2015
    Last Verified:
    Feb 1, 2015
    Keywords provided by Mariella Withagen, Dr. M.I.J. Withagen, Radboud University Medical Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 6, 2015