To study which technique is most effective to surgically correct a symptomatic cystocele.2. To compare morbidity and post-operative recovery of anterior colporraphy and PerigeeTM.3. To compare the need for repeated pelvic floor surgery following…
ID
Source
Brief title
Condition
- Bladder and bladder neck disorders (excl calculi)
- Obstetric and gynaecological therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Disease specific quality of life.
Secondary outcome
1. Morbidity
2. Duration of catheter use
3. POP-Q score (Anatomical effect)
4. General quality of life
5. Performed surgical procedures in the first year after primary cystocele
repair.
Background summary
Anterior colporraphy has been the standard surgical procedure to correct a
cystocele. The risk on recurrence after this procedure is high. PerigeeTM is a
new surgical procedure to correct cystocele. During this procedure a
polypropylene mesh is placed between the anterior vaginal wall and the bladder.
We aim to study whether anterior colporraphy or PerigeeTM is preferable in
patients undergoing cystocele repair.
Study objective
To study which technique is most effective to surgically correct a symptomatic
cystocele.
2. To compare morbidity and post-operative recovery of anterior colporraphy and
PerigeeTM.
3. To compare the need for repeated pelvic floor surgery following anterior
colporraphy and PerigeeTM.
Study design
A randomized controlled trial will be performed
Intervention
Anterior colporraphy or perigee
Study burden and risks
All patients are asked to complete a questionnaire before and at 6 weeks, 3
months and 12 months after surgery. Patients hold a diary from the day of
surgery until 6 weeks after surgery. Patients visit the hospital for additional
visits at 3 months and 12 months after surgery.
Meibergdreef 9
1105 AZ Amsterdam
Nederland
Meibergdreef 9
1105 AZ Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
Patients who are candidate to undergo surgical correction of cystocele.
Exclusion criteria
Patients who simultaneously have to undergo surgical correction of vault prolapse or rectocele are excluded. Patients who simultaneously have to undergo vaginal hysterectomy or stress-incontinence surgery are not excluded.
Design
Recruitment
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 | NL14963.018.06 |