Advanced Search

Study Preview



Study Title and Description

Observational study on safety and tolerability of duloxetine in the treatment of female stress urinary incontinence in German routine practice.



Key Questions Addressed
1 KQ 1: What are the benefits and harms of nonpharmacological treatments of UI in women, and how do they compare with each other? KQ 2: What are the benefits and harms of pharmacological treatments of UI in women, and how do they compare with each other? KQ 3: What are the comparative benefits and harms of nonpharmacological versus pharmacological treatments of UI in women? KQ 4: What are the benefits and harms of combined nonpharmacological and pharmacological treatment of UI in women?
  • Comments Comments (
    0
    ) |

Primary Publication Information
  • Comments Comments (
    0
    ) |
TitleData
Title Observational study on safety and tolerability of duloxetine in the treatment of female stress urinary incontinence in German routine practice.
Author Michel MC., Minarzyk A., Schwerdtner I., Quail D., Methfessel HD., Weber HJ.
Country Department of Pharmacology, Johannes Gutenberg University, Mainz, Germany. martin.michel@boehringer-ingelheim.com
Year 2013
Numbers Pubmed ID: 22816871

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: All studies
Arms
Number Title Description Comments
1 Dulox-12 treatment with duloxetine for 12 weeks
  • Comments Comments (
    0
    ) |
2 Other-12 Treatment with treatment other than duloxetine for 12 weeks
  • Comments Comments (
    0
    ) |
3 Dulox-24 treatment with duloxetine for 24 weeks
  • Comments Comments (
    0
    ) |
4 Other-24 Treatment other than duloxetine for 24 weeks
  • Comments Comments (
    0
    ) |

Design Details
Question... Follow Up Answer Follow-up Answer
Study type NRCS
  • Comments Comments (
    0
    ) |
Country/countries Germany
  • Comments Comments (
    0
    ) |
Funding source Industry funded/industry provided materials
  • Comments Comments (
    0
    ) |
Inclusion criteria moderate to severe stress urinary incontinence symptoms, 18 years and older
  • Comments Comments (
    0
    ) |
Exclusion criteria planned SUI surgery during observation period
  • Comments Comments (
    0
    ) |
UI type
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
100
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
Directionality Prospective
  • Comments Comments (
    0
    ) |
Age 59.39
  • Comments Comments (
    0
    ) |
mean
  • Comments Comments (
    0
    ) |
12.45
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
Men included 0
  • Comments Comments (
    0
    ) |
Special populations
  • Comments Comments (
    0
    ) |
100
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
Race
  • Comments Comments (
    0
    ) |
100
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
Notes
  • Comments Comments (
    0
    ) |
Did participants fail previous treatment? Not reported/unclear
  • Comments Comments (
    0
    ) |
Study years 2005-2008
  • Comments Comments (
    0
    ) |
Trial name (if given) DUROSA
  • Comments Comments (
    0
    ) |
Does this paper cite a previous paper from the same study?
  • Comments Comments (
    0
    ) |


Baseline Characteristics
Question Dulox-12 Other-12 Dulox-24 Other-24 Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant flow 4913 1941 4010 1869 12733
  • Comments Comments (
    0
    ) |
4353 1837 3759 1784 11733
  • Comments Comments (
    0
    ) |
560 104 251 85 1000
  • Comments Comments (
    0
    ) |
missing data, early discontinuation missing data, early discontinuation missing data, early discontinuation missing data, early discontinuation missing data, early discontinuation
  • Comments Comments (
    0
    ) |
Notes No data entered.



Results & Comparisons

No Results found.

Quality Dimensions
Dimension Value Notes Comments
RCT:.....Adequate generation of a randomized sequence
  • Comments Comments (
    0
    ) |
RCT:.....Allocation concealment
  • Comments Comments (
    0
    ) |
RCT:.....Blinding of PATIENTS
  • Comments Comments (
    0
    ) |
RCT.....Intention-to-treat-analysis
  • Comments Comments (
    0
    ) |
ALL.....Blinding of OUTCOME ASSESSORS (or "DOUBLE BLIND") High RoB open-label
  • Comments Comments (
    0
    ) |
ALL.....Incomplete results data (attrition bias) Low RoB
  • Comments Comments (
    0
    ) |
ALL....Group similarity at baseline (selection bias) High RoB baseline characteristics differed between groups
  • Comments Comments (
    0
    ) |
ALL.....Compliance with interventions Unclear RoB drop-outs with missing data, no patient compliance measures noted.
  • Comments Comments (
    0
    ) |
NRCS.....Patients in different intervention groups selected in an equivalent manner Unsure placed in group based on doctor prescribing. Patient placed in groups based on doctor decision
  • Comments Comments (
    0
    ) |
NRCS....Baseline differences between groups accounted for (Adjusted analysis)? Unsure no mention of adjusting for baseline characteristic differences
  • Comments Comments (
    0
    ) |
ALL.....Other issues No
  • Comments Comments (
    0
    ) |
ALL....Were interventions adequately described? Yes
  • Comments Comments (
    0
    ) |

Quality Rating
No quality rating data was found.