Effectiveness Prolift+M Versus Conventional Vaginal Prolapse Surgery

NCT ID: NCT02231099

Last Updated: 2015-02-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 176 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2015-09-30

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.

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.

Conditions

Pelvic Organ Prolapse; Cystocele; Rectocele; Uterine Prolapse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

prolift + m

surgery with mesh (prolift+M)

Group Type: EXPERIMENTAL

Prolift + M

Intervention Type: PROCEDURE

prolapse surgery with mesh

conventional vaginal prolapse surgery

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

Group Type: ACTIVE_COMPARATOR

conventional vaginal prolapse surgery

Intervention Type: PROCEDURE

conventional vaginal prolapse surgery;anterior colporrhaphy, posterior colporrhaphy

Interventions

Prolift + M

prolapse surgery with mesh

Intervention Type: PROCEDURE

conventional vaginal prolapse surgery

conventional vaginal prolapse surgery;anterior colporrhaphy, posterior colporrhaphy

Intervention Type: PROCEDURE

Other Intervention Names

anterior colporrhaphy, posterior colporrhaphy

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Mariella Withagen

Dr. M.I.J. Withagen

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mariella IJ Withagen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud Medical Center

Locations

Gelre ziekenhuizen Apeldoorn

Apeldoorn, , Netherlands

Reinier de Graaf Group

Delft, , Netherlands

UMC St Radboud

Nijmegen, , Netherlands

Zaans Medisch Centre

Zaandam, , Netherlands

Isala clinics

Zwolle, , Netherlands

Countries

Netherlands

Other Identifiers

VROUW2

Identifier Type: -

Identifier Source: org_study_id