cystocele vaginal prolapse
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
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Women aged 40-80 years Cystocele stage >= 2 according to POP Q classification No previous anterior colporraphy 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is the number of women who will have a recurrence, defined as a stage >= 2 anterior vaginal prolapse at 2 years follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are; - The effect of surgery on urogenital symptoms and quality of life - Complications of surgery (direct and medium term) - Cost-effectiveness analysis. | — |
Countries
Netherlands
Outcome results
None listed