Pelvic Organ Prolapse
Conditions
Keywords
POP, prolapse, perineoplasty
Brief summary
The goal of this study is to evaluate whether adding perineoplasty is, in comparison to performing vaginal prolapse surgery without adding perineoplasty, superior with respect to efficacy and cost-effectiveness and non-inferior with respect to morbidity, in patients undergoing vaginal surgical correction of pelvic organ prolapse at 24 months after surgery.
Detailed description
Preoperative measurements, performed at baseline: * Patient characteristics (age, BMI, smoking, obstetric history) * Physical examination including POP-Q score. The genital hiatus (gh) at rest (as part of the POP-Q) will be used to assess the wideness of the vaginal introitus. * Pelvic Floor Distress Inventory (PFDI-20) questionnaire and Patient Global Impression of Severity (PGI-S) * Pelvic Floor Ultrasound 2DStudy measurements; * Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-ir), Dutch Perineal Support Questionnaire (DPSQ), General Quality of Life (EQ-5D-5L), Medical Consumption Questionnaire (iMCQ) and Productivity Cost Questionnaire (iPCQ) * Patient and surgeons considerations with respect to level III repair; Postoperative measurements: * Regular physical check-up will be at 4-8 weeks after procedure. * Physical examination including POP-Q score * Patient Global Impression of Improvement score (PGI-I) * Pelvic Floor Ultrasound 2D * iMCQ, iPCQ, EQ-5D-5L questionnaire Extra follow up: * Physical check-up 12 & 24 months after surgery: * Physical examination including POP-Q score * Pelvic Floor Ultrasound 2D * PFDI-20, PGI-I, DPSQ, PISQ-ir, iMCQ, iPCQ, EQ-5D-5L questionnaire
Interventions
None listed
Sponsors
Spaarne Gasthuis
Marjolein Spiering
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Female patient \>18 years of age 2. Complaints of pelvic organ prolapse 3. Indication for prolapse surgery (level I and/or level II repair) 4. Genital hiatus (GH) according to POP-Q staging of ≥4 cm and ≤7 cm
Exclusion criteria
1. Unable to understand the Dutch language 2. Pregnancy at baseline or intendancy to become pregnant during the study period 3. Patients with previous surgery for POP (previous mid urethral sling operations for urinary stress incontinence not excluded) 4. Unwilling and / or incapable of giving informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical success | 12 months | composite outcome defined as meeting the 3 following conditions: \[1\] much improved or improved in response to the patient global impression of improvement questionnaire, \[2\] no re-intervention performed in the same compartment within the first 12 months after index surgery, \[3\] no stage 2 or more POP in the operated compartment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Morbidity | 24 months | complications and re-interventions due to complications, pain |
| Effectiveness | 24 months | disease specific and general quality of life |
| Anatomical outcomes | 24 months | — |
| Societal costs | 24 months | — |
Countries
Netherlands
Outcome results
None listed