A PROSPECTIVE AND COMPARATIVE STUDY OF THE (COST) EFFECTIVENESS OF TENSION FREE VAGINAL MESH PLUS MONOCRYL (PROLIFT+MTM) VERSUS CONVENTIONAL VAGINAL PROLAPSE SURGERY IN PRIMARY PROLAPSE

A PROSPECTIVE AND COMPARATIVE STUDY OF THE (COST) EFFECTIVENESS OF TENSION FREE VAGINAL MESH PLUS MONOCRYL (PROLIFT+MTM) VERSUS CONVENTIONAL VAGINAL PROLAPSE SURGERY IN PRIMARY PROLAPSE - VROUW 2

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35003

Enrollment

176

Registered

2010-07-29

Start date

2011-01-19

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pelvic organ prolapse

Interventions

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

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: primary pelvic organ prolapse (anterior and/or posterior compartment) POP stage II or more age >44 years

Exclusion criteria

Exclusion criteria: pregnancy age

Design outcomes

Primary

Measure	Time frame
The main outcome is the percentage of patients with objective anatomical success (POP stage	—

Secondary

Measure	Time frame
As secondary outcome the subjective improvement in quality of life will be measured by generic (EQ-5D) 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.	—

Measure

Time frame

As secondary outcome the subjective improvement in quality of life will be measured by generic (EQ-5D) 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.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)