Genital prolapse Urological and Genital Diseases Female genital prolapse
Conditions
Interventions
Anteror fascial repair vs anterior mesh repair
Sponsors
Benenden Hospital Trust (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women with symptomatic anterior vaginal wall prolapse needing surgery 2. Age: No age limits
Exclusion criteria
Exclusion criteria: 1. Contraindication to mesh repair surgery: unstable diabetes, long term high dose steroids, prosthetic heart valve, marked immunosuppression 2. Connective tissue disorders (Ehler-Danlos or Marfan's) 3. Inability to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anatomical recurrence rate assessed using the Pelvic Organ Prolapse Quantification (POPQ) scores, assessed immediately after surgery and then 6 weeks, 6 months, 1 and 2 years post-operation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Operating time 2. Blood loss 3. Peri-operative complications 4. Hospital stay 5. Time to recovery to normal life 6. Long-term complications (including mesh erosion). Duration of follow-up: 24 months 7. Bladder and sexual function at 6, 12 and 24 months 8. Quality of life, assessed using the EuroQol questionnaire and the Sheffield Prolapse Symptoms Questionnaire at 6, 12 and 24 months 9. Patient satisfaction, assessed at 6, 12 and 24 months 10. Pain score, assessed daily up to 7 days post-operation | — |
Countries
United Kingdom
Outcome results
None listed