The primary objective is to compare the effectiveness and cost-effectiveness of pessary versus surgery as initial treatment formoderate to severe symptomatic pelvic organ prolapse (POP) in women at two year after initiation of treatment.The…
ID
Source
Brief title
Condition
- Obstetric and gynaecological therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome: Global impression of improvement of POP symptoms at 24 months
measured with PGI-I
Secondary outcome
Secondary outcomes:
* Changes in symptom bother and disease-specific quality of life at 12 and 24
months follow-up
* Changes of sexual function at 12 and 24 months follow-up
* Changes in general quality of life at 3, 6, 12 and 24 months.
* Adverse events/complications related to both treatment strategies during the
study period
* Development of prediction model to identify factors for failing of pessary
and surgery.
* Costs-effectiveness analyses
Background summary
Moderate to severe pelvic organ prolapse symptoms can be treated with pessary
or surgery. Both treatments appear to be
effective, but have not been compared directly.
Study objective
The primary objective is to compare the effectiveness and cost-effectiveness of
pessary versus surgery as initial treatment for
moderate to severe symptomatic pelvic organ prolapse (POP) in women at two year
after initiation of treatment.
The secondary objective is the development of a prediction model for failure of
pessary use and surgery within 2 years.
HYPOTHESIS
The strategy of pessary as initial therapy is as effective as direct surgery
for moderate to severe POP, but it is associated with
lower costs.
Study design
Multicenter pragmatic cohort study with an embedded randomised controlled
non-inferiority trial comparing pessary therapy versus surgery including an
economic evaluation.
Intervention
Pessary therapy or POP surgery
Study burden and risks
SAMPLE SIZE
With 198 women per group, we will have 80% power to reject the null hypothesis
that pessary therapy is inferior to surgery, with
a 1-sided alpha of 0.05, a non-inferiority margin of 10% and the proportion in
the standard group is 80%.
Accounting for 10% loss to follow-up we plan to randomize 436 patients.
ANTICIPATED HEALTHCARE EFFICIENCY GAIN
Annually a total budget impact of 10-14 million euro health care costs for
comparable health outcomes and 20-28 million euro
economic impact on society.
FEASIBILITY
The project group is experienced in performing large-scale intervention
studies. The study will be performed within our Dutch
national obstetrics and gynaecology consortium. This consortium infrastructure
has proven to be very effective.
TIME SCHEDULE
48 months
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
1. Women with a prolapse stage 2 or more.
2. Women with moderate to severe POP symptoms. Moderate to severe POP symptoms is defined as a prolapse domain score > 33 on the validated Dutch version of the Pelvic Floor Distress Inventory (PFDI-20).
3. Women who have had a successful pessary fitting procedure: for the RCT.
4. Written informed consent
Exclusion criteria
1. Prior urogynaecological (prolapse or incontinence) surgery
2. Probability of future childbearing
3. Insufficient knowledge of the Dutch language
4. Co-morbidity causing increased surgical risks
5. Major psychiatric illness
6. Prior pessary use
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 | NL50717.041.14 |