Vaginal wall prolapse Urological and Genital Diseases Female genital prolapse
Conditions
Interventions
All women having primary or secondary pelvic organ prolapse surgery for anterior and/or posterior vaginal wall prolapse and who consent to participate will be included in the study.
I
Sponsors
University of Aberdeen (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Women (no age limits) having primary or secondary pelvic organ prolapse surgery for anterior and/or posterior vaginal wall prolapse who are willing and eligible to be randomised Notes: 1. Women who are unwilling or ineligible for randomisation will be eligible to be followed up using the same protocol as part of the comprehensive cohort 2. Women undergoing concurrent hysterectomy/cervical amputation, vault surgery or continence procedures are also eligible
Exclusion criteria
Exclusion criteria: 1. Women undergoing prolapse surgery who are unwilling or unable to participate in the study 2. Women who are unable or unwilling to give competent informed consent, or are unable to complete study questionnaires
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Primary patient-reported outcome: 1.1. Symptoms of prolapse, measured as the frequency of prolapse symptoms on the Pelvic Organ Prolapse Symptom Scale (POP-SS) at two years after surgery 1.2. Quality of life (Visual Analogue Scale) outcome measured as the overall effect of prolapse symptoms on everyday life 2. Cost effectiveness: incremental cost per quality-adjusted life year (QALY) based on Euroqol EQ-5D data All primary and secondary outcomes are measured at 6, 12 and 24 months, measured in participant-completed questionnaires. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. General 1.1. Immediate and late post-operative morbidity 1.2. Other adverse effects or complications including mesh erosion or removal 1.3. Operating time 1.4. Blood loss 1.5. Number of nights in hospital 1.6. Time until resumption of usual activities 1.7. Need for further surgery for prolapse or for urinary incontinence 1.8. Time to further surgery 1.9. Satisfaction with surgery 2. Prolapse outcomes 2.1. Subjective recurrence of prolapse 2.2. Subjective continuation /recurrence of prolapse symptoms 2.3. Objective residual prolapse stage (POP-Q) at original site 2.4. Development of new (de novo) prolapse at another site 2.5. Need for other conservative prolapse treatment (e.g., pelvic floor muscle training [PFMT], mechanical device) 3. Urinary outcomes 3.1. Urinary incontinence (persistent or de novo, and types of incontinence) 3.2. Need for alternative management for incontinence (e.g., PFMT, mechanical devices, surgery, drugs, intermittent catheterisation) 4. Bowel outcomes 4.1. Constipation (persistent or de novo) 4.2. Faecal incontinence (persistent or de novo) 5. Sexual function outcomes 5.1. Dyspareunia/ apareunia/ difficulty with intercourse 5.2. Vaginal symptoms 6. Quality of life outcome measures 6.1. Condition-specific quality of life measure (e.g. physical activity, social, hygiene, sexual) 6.2. General health measures 7. Economic outcome measures 7.1. Cost and use of NHS services 7.2. Cost to the women and their families/carers 7.3. QALYs estimated from the r | — |
Countries
United Kingdom
Outcome results
None listed