To compare the clinical and cost-effectiveness of an anterior colporraphy repair with a cystocele repair with the use of the non-absorbable synthetic Avaulta® mesh.
ID
Source
Brief title
Condition
- Obstetric and gynaecological therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
Secondary endpoints are;
- The effect of surgery on urogenital symptoms and quality of life
- Complications of surgery (direct and medium term)
- Cost-effectiveness analysis.
Background summary
After a standard surgical anterior colporraphy for an anterior vaginal wall
prolapse (cystocele) grade 2 or higher, one-third of women will have an
anatomical recurrence within 2 years after primary surgery. The use of a
non-absorbable synthetic polypropylene mesh has been shown to be effective in
repeat surgery for genital prolapse, with a recurrence rate between 3-12%.
However, a comparative study between the anterior colporraphy and surgery with
a non-absorbable synthetic mesh as primary treatment for an anterior vaginal
wall prolapse has not been conducted.
Study objective
To compare the clinical and cost-effectiveness of an anterior colporraphy
repair with a cystocele repair with the use of the non-absorbable synthetic
Avaulta® mesh.
Study design
Single-blinded, multicenter, randomised controlled trial
Intervention
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.
Study burden and risks
All women participating will have their regular pre- and postoperative care,
which consists of a scheduled visit after 6 weeks and one year. In addition an
extra visit after 6 months and 2 years is planned. Before surgery and during
all scheduled 4 postoperative visits, the women will undergo a gynaecologic
physical examination, POP-Q assessment and fill in questionnaires related to
the study. In the direct postoperative period, a diary for 7 days will be
filled in by the woman. Apart from the use of questionnaires, no addition
diagnostic tests are planned. In relation to the use of the Avaulta® mesh,
women with the mesh have a slight increased risk of repeated surgery in
relation to mesh erosion problems as compared to women after a classical
repair.
Heidelberglaan 100
Utrecht
NL
Heidelberglaan 100
Utrecht
NL
Listed location countries
Age
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
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL13436.041.06 |