Effectiveness Prolift+M Versus Conventional Vaginal Prolapse Surgery (VROUW2)

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

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.

Study Overview

• Status: Unknown
• Conditions: Pelvic Organ Prolapse; Cystocele; Uterine Prolapse; Rectocele
• Intervention / Treatment: Procedure: Prolift + M; Procedure: conventional vaginal prolapse surgery

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 Type: Interventional
• Enrollment (Anticipated): 176
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Apeldoorn, Netherlands
    • Gelre Ziekenhuizen Apeldoorn
  • Delft, Netherlands, 2625 AD
    • Reinier de Graaf Group
  • Nijmegen, Netherlands, 6500 HB
    • UMC St Radboud
  • Zaandam, Netherlands, 1500 EE
    • Zaans Medisch Centre
  • Zwolle, Netherlands, 8025 AB
    • Isala Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
objective anatomic success (POPQ stage <2)	clinical investigation including POPQ	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
subjective improvement in quality of life	Questionnaires; Euroqol5D, PGI-I, UDI, DDI and PFDI20	24 months
sexual function/dysfunction	PISQ-12, BESAQ	24 months
complications	clinical investigation	24 months
recovery	Recovery Index 10	6 weeks
cost-effectiveness	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.	24 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Anticipated): September 1, 2015
• Study Completion (Anticipated): September 1, 2015

Study Registration Dates

• First Submitted: January 27, 2012
• First Submitted That Met QC Criteria: August 31, 2014
• First Posted (Estimate): September 4, 2014

Study Record Updates

• Last Update Posted (Estimate): February 6, 2015
• Last Update Submitted That Met QC Criteria: February 5, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: mesh; recurrent pelvic organ prolapse
• Additional Relevant MeSH Terms: Digestive System Diseases; Urologic Diseases; Urinary Bladder Diseases; Uterine Diseases; Gastrointestinal Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Rectal Diseases; Hernia; Prolapse; Pelvic Organ Prolapse; Cystocele; Uterine Prolapse; Rectocele
• Other Study ID Numbers: VROUW2