Vault or uterine prolapse surgery evaluation: the VUE study

Conditions

Vaginal wall prolapse Urological and Genital Diseases Cystocele

Christine Hemming, Lynda Constable, Beatriz Goulão, Mary Kilonzo, Dwayne Boyers et al. (15 authors)

Health Technology Assessment2020-03-0130 citations

Two parallel, pragmatic, UK multicentre, randomised controlled trials comparing surgical options for upper compartment (vault or uterine) pelvic organ prolapse (the VUE Study): study protocol for a randomised controlled trial.

Glazener C, Constable L, Hemming C, Breeman S, Elders A, Cooper K, Freeman R, Smith AR, Hagen S, McDonald A, McPherson G, Montgomery I, Kilonzo M, Boyers D, Goulao B, Norrie J.

2016-09-083 citations

10.1186/s13063-016-1576-x

Interventions

Vault Trial The two broad approaches to vault suspension are vaginal or abdominal. Participants will be randomised to either 1. Vaginal vault suspensio

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Women with vault or uterine prolapse requiring a surgical procedure 2. Women who are suitable for randomisation (gynaecologist?s view, i.e. not meeting exclusion criteria) 3. Women who are willing to be randomised (woman?s view)

Exclusion criteria

Exclusion criteria: 1. Potential future pregnancies 2. Co-morbidity necessitating particular approach, eg fibroids, previous abdominal surgery (scarring / adhesions) 3. Co-morbidity precluding randomisation (eg poor anaesthetic risk) 4. Obesity precluding abdominal approach (except if two vaginal approaches are feasible) 5. Colpocleisis (vaginal closure operation) 6. Women who are unwilling, unable or unsuitable to be randomized

Design outcomes

Primary

Measure	Time frame
1. The primary clinical outcome is women?s prolapse symptoms measured using the Pelvic Organ Prolapse Symptom Scale (POP-SS), at one year after surgery. 2. The primary quality of life outcome is the overall effect of prolapse symptoms on everyday life. 3. The primary economic outcome measure of cost effectiveness is incremental cost per QALY (QALYs based on the EQ-5D data). All primary and secondary outcomes are measured at 6 and 12 months after surgery, measured in participant-completed questionnaires.	—

Measure

Time frame

1. The primary clinical outcome is women?s prolapse symptoms measured using the Pelvic Organ Prolapse Symptom Scale (POP-SS), at one year after surgery. 2. The primary quality of life outcome is the overall effect of prolapse symptoms on everyday life. 3. The primary economic outcome measure of cost effectiveness is incremental cost per QALY (QALYs based on the EQ-5D data). All primary and secondary outcomes are measured at 6 and 12 months after surgery, measured in participant-completed questionnaires.

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Secondary

Measure	Time frame
1. General 1.1. Immediate and late post-operative morbidity 1.2. Other adverse effects or complications 1.3. Operating time 1.4. Blood loss 1.5. Number of nights in hospital 1.6. Number of readmissions to hospital 1.7. Need for further surgery for prolapse or for urinary incontinence 1.8. Time to further surgery 1.9. Recommendation to a friend 1.10. Satisfaction with surgery 2. Prolapse outcomes 2.1. Subjective recurrence of prolapse 2.2. Subjective continuation / recurrence of prolapse symptoms 2.3. Subjective 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. PFMT, mechanical device) 3. Urinary outcomes 3.1. Urinary incontinence (persistent or de novo, and types of incontinence) using the ICI- Questionnaires 3.2. Voiding dysfunction 3.3. Need for alternative management for incontinence or voiding dysfunction (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 using the ICI-Vaginal Symptoms questionnaire 6. Quality of life outcome measures 6.1. Condition-specific quality of life measures 6.2. General health measures (EQ-5D) 7. Economic outcome measures 7.1. Cost and use of NHS services 7.2. Cost to the wom	—

Measure

Time frame

1. General 1.1. Immediate and late post-operative morbidity 1.2. Other adverse effects or complications 1.3. Operating time 1.4. Blood loss 1.5. Number of nights in hospital 1.6. Number of readmissions to hospital 1.7. Need for further surgery for prolapse or for urinary incontinence 1.8. Time to further surgery 1.9. Recommendation to a friend 1.10. Satisfaction with surgery 2. Prolapse outcomes 2.1. Subjective recurrence of prolapse 2.2. Subjective continuation / recurrence of prolapse symptoms 2.3. Subjective 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. PFMT, mechanical device) 3. Urinary outcomes 3.1. Urinary incontinence (persistent or de novo, and types of incontinence) using the ICI- Questionnaires 3.2. Voiding dysfunction 3.3. Need for alternative management for incontinence or voiding dysfunction (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 using the ICI-Vaginal Symptoms questionnaire 6. Quality of life outcome measures 6.1. Condition-specific quality of life measures 6.2. General health measures (EQ-5D) 7. Economic outcome measures 7.1. Cost and use of NHS services 7.2. Cost to the wom

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Countries

United Kingdom

Outcome results

None listed