Pelvic Organ Prolapse Clinical Trial
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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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