anterior prolapse surgery
Conditions
Interventions
Women are either allocated to a group who will undergo a classic anterior colporraphy repair or a group in which the Avaulta®
mesh is used
Sponsors
University Medical Center Utrecht (UMCU)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Women aged 40-80 years 2. Cystocele stage ¡Ý 2 according to POP Q classification 3. No previous anterior colporraphy 4. Good understanding of Dutch language in word en writing
Exclusion criteria
Exclusion criteria: 1. Women with childbearing potential who do not use adequate contraceptive measures (hormonal contraceptives, barrier methods (condoms), intra uterine device, male vasectomy, sterilisation). 2. History of major gynaecological or urological surgery, with the exception of a hysterectomy for reasons other than a genital prolapse. 3. History of cancer or severe cardiopulmonary disease 4. Conditions that might interfere with a successful conduction and completion of the study in the opinion of the specialist (language problems, cognitive dysfunction, etc) 5. Recurrent lower urinary tract infections (> 3 culture proven infections/year) 6. Maximum bladder capacity < 300 ml (bladder diary) 7. Urinary stress incontinence with an indication for surgical correction.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of women who will have a recurrence, defined as a stage ¡Ý 2 anterior vaginal prolapse at 2 years follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| - The effect of surgery on urogenital symptoms and quality of life - Complications of surgery (direct and medium term) - Cost-effectiveness analysis. | — |
Contacts
Public ContactA. Vollebregt
Spaarne Ziekenhuis Hoofddorp Department of Gynaecology
Outcome results
None listed