| Methods |
RCT (double blind, parallel groups, placebo controlled)
ITT
Setting: USA |
| Participants |
n= 47 women
Dropouts: 3 other women excluded (failed inclusion criteria 1; personal reason 1; headache 1)
Inclusion: USI
Exclusion: severe genital prolapse, neurological disease, hypertension, heart disease, diabetes mellitus, organic bladder diseases, senility, drugs acting on lower urinary tract, DI, residual urine >50 ml on two occasions.
Age range: 23‐73 years
Menopausal: I:8, II: 7 |
| Interventions |
I (21): Placebo 3 times /day, oral
II (23): Norepinephrine 5 mg 3 times /day, oral, sustained release
Duration of study: 6 weeks, dose doubled after first 3 weeks if no effect |
| Outcomes |
Dose increased after first 3 weeks: I: 17/21, II: 18/21
Subjective cure: I: 3/21, II: 6/23
Subjective improvement: I: 7/21. II: 12/23
Objective cure (stress test): I: 7/21, II: 7/23
Objective improvement: I:5/21, II:11/23
Swapped to alternative arm after end of trial: I: 10/21, II: 10/23
Continence surgery: I: 5/21, II: 5/23
Long term cure after 1 year: I: 8/21, II: 6/23 (but not trial outcome)
Adverse events: I: 1/21, II:5/23 (headache, dizziness, palpitations) |
| Notes |
Sample size calculation give
Comparison: Adrenergic drug (norepinephrine) versus placebo |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
