We propose a study to compare the cost-effectiveness of the new UBA to MUS surgery.
ID
Source
Brief title
Condition
- Genitourinary tract disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome of this study is subjective improvement assessed by the
1-item questionnaire *Patient Global Impression of Improvement* (PGI-I). The
PGI-I has a 7-point Likert scale with a response range from *very much worse*
to *very much better*. Improvement is considered to be clinically significant
when answers to the PGI-I are either *much better* or *very much better*.
Subjective improvement will be assessed at 4-6 weeks, 6 months and 12 months.
Secondary outcome
- Economic evaluation
- Subjective cure
- Objective cure
- Morbidity and complications
- Disease specific quality of life
- Seksual function
- Re-interventions
- Patient preference
Background summary
Urinary incontinence (UI) is a major public health issue affecting up to 29-57%
of all women. In 2014 only in the
Netherlands, 150 million Euros were spent on incontinence material. Stress
urinary incontinence (SUI) is the most
common type of UI and is defined as the leakage of urine, which occurs during
physical activity of exertion or on sneezing or
coughing. It has been reported that the prevalence of SUI is 25 to 45% in women
aged over 40.
Subjective cure rates of mid-urethral sling (MUS) surgery reported in the most
recent Cochrane review were 62-97%. An
alternative surgical procedure involves urethral bulking agents (UBA), during
which via the urethra, or peri-urethral, a
biomaterial is injected to compress the mid-urethra. Reported efficacy rates
are lower as compared to those of MUS surgery,
due to migration of the biomaterial. However the exact indication of UBA has
not been well established and practice variation
exists.
Recently, a new type of UBA was developed, which a theoretically much lower
risk on migration. This UBA consists of polydimethylsiloxane (PDMS) (brand
name: Urolastic. Urogyn BV, Nijmegen, Netherlands) was introduced. The
hypothetical mechanism of action of UBA is that by the injection of a
biomaterial into the urethral submucosa, artificial urethral cushions are
created that can improve urethral coaptation and hence restore continence. The
unique feature of the new type of UBA is that PDMS polymerises in situ forming
into an uniform elastomer that adapts itself to the environment during
injection. This results in a large, non-degradable homogeneous mass that
becomes encapsulated by the body as a whole and, as a result, can,
theoretically, not migrate. Moreover, since this material is non-absorbable it
is hypothesized that PDMS will give a long lasting effect. A small study
prospective cohort study reported an overall success-rate of 89% after 12
months follow up, which is
similar to the success of MUS surgery.
As compared to as MUS surgery, UBA has some advantages. First of all, UBA has a
better safety profile (no risk to perforate visceral organs of the pelvic
cavity). Secondly, the procedure is done under local anesthesia. Finally, the
procedure is performed in an outpatient setting.Therefore,
UBA can be more cost-effective than MUS-surgery.
Study objective
We propose a study to compare the cost-effectiveness of the new UBA to MUS
surgery.
Study design
Prospective, matched-controlled cohort studie with a follow-up of 12 months.
Study burden and risks
In this research study we will evaluate two standard treatments for SUI: UBA
and MUS-surgery. The burden of the research is minimal (questionnaires, 1
outpatients visit and 1 telephonic consult) and the investigation itself brings
no additional risk for the subject.
Therefore the risk of this research is negligible.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
1. Subject is at least 18 years of age
2. Subject has bothersome, moderate or severe SUI or stress predominant mixed
urinary incontinence (Sandvik severity scale of 3 and higher).
3. Subject has decided to undergo a MUS-operation or treatment with UBA
*Urolastic**
4. Subject has a positive result on the standardized cough stress test
5. Subject is willing and able to comply with the follow-up regime
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
1. Subject has predominating urge incontinence
2. Subject has a genital prolapse with a POP-Q score of point Aa or Ba >/=0
3. Subject has had previous treatment with UBA.
4. Subject is pregnant or intends to become pregnant during the study.
5. Subject has a untreated urinary tract infection
6. Subject has a bladder capacity of <250ml
7. Subject has a post-voiding residu of >150ml
8. Subject has a flow of <15ml/sec
9. Subject is not capable of giving informed consent
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL59107.018.16 |
| OMON | NL-OMON21563 |