urinary incontinence
Conditions
Interventions
None listed
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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 150ml 8. Subject has a flow of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| - Economic evaluation - Subjective cure - Objective cure - Morbidity and complications - Disease specific quality of life - Seksual function - Re-interventions - Patient preference | — |
Countries
Netherlands
Outcome results
None listed