Mesh vs anterior repair surgery for vaginal prolapse

Not Applicable

Completed

Conditions: Genital prolapse
Urological and Genital Diseases
Female genital prolapse

Registration Number: ISRCTN69747860

Lead Sponsor: Benenden Hospital Trust (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 250

Inclusion Criteria

1. Women with symptomatic anterior vaginal wall prolapse needing surgery
2. Age: No age limits

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
1. Operating time<br>2. Blood loss<br>3. Peri-operative complications <br>4. Hospital stay<br>5. Time to recovery to normal life<br>6. Long-term complications (including mesh erosion). Duration of follow-up: 24 months<br>7. Bladder and sexual function at 6, 12 and 24 months<br>8. Quality of life, assessed using the EuroQol questionnaire and the Sheffield Prolapse Symptoms Questionnaire at 6, 12 and 24 months<br>9. Patient satisfaction, assessed at 6, 12 and 24 months<br>10. Pain score, assessed daily up to 7 days post-operation