The objective of the pilot study is to get information on the recruitment of patients, the filling in of the questionnaires, the micturition diary, the course of and information from the interview and about the logistics of the urogynaecological…
ID
Source
Brief title
Condition
- Genitourinary tract disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
In the pilot the recruitment procedure is studied, the quality of the data from
the questionnaires and the micturition diary and the logistics of the
urogynaecological examination. Also, the time investment is measured.
Secondary outcome
niet van toepassing
Background summary
Many elderly women with involuntary loss of urine go undiagnosed and untreated.
Proven effective treatments are underused. There is a lack of data on the
cost-effectiveness of an active, protocolized assesment and evidence based
treatment of urinary incontinence. That is why a preliminary application is
made with ZonMW for a randomized clinical trial of urinary incontinence in
elderly women.
A pilot study is needed to study the recruitment of patients and the diagnostic
pathway in general practice and at the outpatient department for pelvic floor
studies of the UMCG.
Study objective
The objective of the pilot study is to get information on the recruitment of
patients, the filling in of the questionnaires, the micturition diary, the
course of and information from the interview and about the logistics of the
urogynaecological examination.
With these data the intervention in the experimental group of patients can be
planned optimally. In the pilot study special attention is paid to the impact
of the diagnostic pathway for the patient, teh quality of the data from the
questionnaires and the time needed for the urogynaecological examination
Study design
The pilto study has an observational design. The diagnostic pathway is tested
that will be followed by patients who wiil be randomized into the intervention
group in the future randomized trial.
Study burden and risks
The subjects in the study population do not run any risk from the
investigations as all tests are non-invasive. The burden of the study consists
of the filling in of questionnaires, the answering of questions in the
interview and the participation in a urogynaecological examination.
Antonius Deusinglaan 1 / Postbus 196
9700 AD Groningen
Nederland
Antonius Deusinglaan 1 / Postbus 196
9700 AD Groningen
Nederland
Listed location countries
Age
Inclusion criteria
Women 55 years or older
Suffering from urinary incontinence: involuntary loss of urine two or more times a month
Able to fill in a questionnaire
Informed consent
Exclusion criteria
Indwelling urinary cateter
Urogynaecological malignancies
Demented
Poor physical condition
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 | NL15480.042.06 |