Kurzfassung

STUDY SYNOPSIS

TITLE A 6-week prospective, observational study in postmenopausal women suffering from SUI symptoms who are treated according to ICI guidelines
SPONSOR/COORDINATING PHYSICIAN Dr. Naumann, Klinik und Poliklinik für Geburtshilfe und Frauenheilkunde der Johannes Gutenberg-Universität Mainz
TYPE OF STUDY Prospective, non-interventional, observational study
PATIENT GROUP Postmenopausal women still suffering from SUI symptoms after initial SUI management Grade A + B acc. to ICI...STUDY SYNOPSIS

TITLE A 6-week prospective, observational study in postmenopausal women suffering from SUI symptoms who are treated according to ICI guidelines
SPONSOR/COORDINATING PHYSICIAN Dr. Naumann, Klinik und Poliklinik für Geburtshilfe und Frauenheilkunde der Johannes Gutenberg-Universität Mainz
TYPE OF STUDY Prospective, non-interventional, observational study
PATIENT GROUP Postmenopausal women still suffering from SUI symptoms after initial SUI management Grade A + B acc. to ICI guidelines, who did not sufficiently respond to initial treatment management and who are starting therapy with Duloxetine
TREATMENT Usual care – no interventions allowed.

OBJECTIVES Primary objective:
To descriptively evaluate the rate of IEF-responders to Duloxetine treatment
Secondary objective:
Descriptive comparison of subgroups (patients w/o local HRT during initial management, responders/non-responders to initial treatment, patients w/o concomitant urge incontinence symptoms) with regard to treatment responders, change from baseline to final visit in stress and urge incontinence episode frequencies, pad use, and global assessment of incontinence severity/change of incontinence severity by the physician; safety and tolerability of Duloxetine.

OBSERVATION CRITERIA Postmenopausal women (discretion of treating gynaecologist)
History of initial SUI therapy Grade A + B acc. to ICI guidelines for at least 12 weeks
No history of SUI surgery
IEF > 14/week
As of todays visit will initiate treatment with Duloxetine
Are not on a waiting list or scheduled for surgery for the treatment of SUI for the next two months
Moderately to severely suffering from SUI symptoms
Not simultaneously participating in any clinical study
Written informed consent.

METHODS This is a prospective, non-interventional, observational study. Physicians will not actively screen for SUI patients. All patients should be identified during the course of a naturally occurring visit. Patient care and treatment choice is only to the discretion of the physician.
Observation will only take place after the treatment decision will have been made.
First observation is scheduled for August 2006; enrolment period will last for five months.
At baseline and 6 (4-8) weeks thereafter assessments are planned.
If the patients want to stop their participation in the study they may do so at any time without any prejudice.
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