Duloxetine in treatment of urinary incontinence in women
Level of evidence: B
Duloxetine likely decreases incontinence episodes slightly in patients with stress urinary incontinence.
In a systematic review and individual participant data meta-analysis on Duloxetine to treat stress urinary incontinence «Maund E, Guski LS, Gøtzsche PC. Considering benefits and harms of duloxetine for treatment of stress urinary incontinence: a meta-analysis of clinical study reports. CMAJ 2017;189(5):E194-E203 »1, Duloxetine 80mg decreased weekly urinary incontinence episodes for -2.85 episodes (-3.91 to -1.78, about 23 % decrease).
Duloxetine probably had little to no impact on health-related quality of life compared to placebo (mean difference 3.24, 95% CI 2.00 to 4.48, about 5 % increase).
A Cochrane review including earlier trials (not included by the IPD MA), suggested similar impact «Mariappan P, Ballantyne Z, N'Dow JM, et al. Serotonin and noradrenaline reuptake inhibitors (SNRI) for stress urinary incontinence in adults. Cochrane Database Syst Rev 2005;2005(3):CD004742 »2.
Specific adverse effects were not reported, however dropout rates due to adverse effects were higher for duloxetine (RR 5.73, 95% CI 4.0 to 8.2, RD 20 %). Indirect evidence on depression suggests an increase in risk of nausea (RD 16 %), dry mouth (RD 8 %), somnolence (6 %), sweating (4 %), dizziness (5 %), constipation (4 %) «Siddiqui F, Petersen JJ, Juul S, et al. Beneficial and harmful effects of duloxetine versus placebo, 'active placebo' or no intervention for adults with major depressive disorder: a systematic review »3.
| Reference | Study type | Population | Intervention and comparison | Outcomes | Risk of bias |
|---|---|---|---|---|---|
| RCT=randomized controlled trial; SR=systematic review; MA=meta-analysis TAE=treatment-related adverse event; IPD=individual participant data | |||||
| «Maund E, Guski LS, Gøtzsche PC. Considering benefits and harms of duloxetine for treatment of stress urinary incontinence: a meta-analysis of clinical study reports. CMAJ 2017;189(5):E194-E203 »1 | SR and IPD MA | Adult women (≥18 yr) with stress urinary incontinence | Duloxetine vs Placebo | Incontinence episodes per week, dropouts due to adverse events | Moderate |
| Reference | Comments |
|---|---|
| «Maund E, Guski LS, Gøtzsche PC. Considering benefits and harms of duloxetine for treatment of stress urinary incontinence: a meta-analysis of clinical study reports. CMAJ 2017;189(5):E194-E203 »1 | Four RCTs. Included only trials submitted to European Medicines Agency. Moderate risk of bias due to high drop out rates. Also measured mean percentage change difference of incontinence episodes as well as adverse event categories of activation event, emotional disturbance and psychotic event. |
Results
| Reference | Number of studies and number of patients | Follow-up time | Mean (sd) I | Mean (sd) C | Mean difference (95% CI) |
|---|---|---|---|---|---|
| Level of evidence: moderate The quality of evidence is downgraded due to moderate risk of bias. I= intervention; C=comparison; CI=confidence interval, MD=mean difference *estimated from weighted baseline incontinence episodes and weighted change in placebo group | |||||
| «Maund E, Guski LS, Gøtzsche PC. Considering benefits and harms of duloxetine for treatment of stress urinary incontinence: a meta-analysis of clinical study reports. CMAJ 2017;189(5):E194-E203 »1 | 4 RCTs, n=1738 | 12 weeks | 12,35* | -2.85 (-3.91 to -1.78) relative effect: -23 % (-14 % to -32 %) | |
| Reference | Number of studies and number of patients | Follow-up time | Mean (sd) I | Mean (sd) C | Mean difference (95% CI) |
|---|---|---|---|---|---|
| Level of evidence: moderate The quality of evidence is downgraded due to moderate risk of bias. I=intervention; C=comparison; CI=confidence interval, MD=mean difference *estimated from weighted baseline incontinence episodes and weighted change in placebo group | |||||
| «Maund E, Guski LS, Gøtzsche PC. Considering benefits and harms of duloxetine for treatment of stress urinary incontinence: a meta-analysis of clinical study reports. CMAJ 2017;189(5):E194-E203 »1 | 4 RCTs, n=1861 | 12 weeks | 69,9* | 3.24 (2.00 to 4.48) relative effect 5 % (3 % to 6 %) | |
| Reference | Number of studies and number of patients | Follow-up time | Absolute number of events (%) I | Absolute number of events (%) C | Relative effect (95% CI) |
|---|---|---|---|---|---|
| Level of evidence: High I=intervention; C=comparison; CI=confidence interval, MD=mean difference | |||||
| «Maund E, Guski LS, Gøtzsche PC. Considering benefits and harms of duloxetine for treatment of stress urinary incontinence: a meta-analysis of clinical study reports. CMAJ 2017;189(5):E194-E203 »1 | 4 RCTs, n=1913 | 12 weeks | 190 (20 %) | 33 (3 %) | RR 5.73 (4.0 to 8.2) |
References
- Maund E, Guski LS, Gøtzsche PC. Considering benefits and harms of duloxetine for treatment of stress urinary incontinence: a meta-analysis of clinical study reports. CMAJ 2017;189(5):E194-E203 «PMID: 28246265»PubMed
- Mariappan P, Ballantyne Z, N'Dow JM, et al. Serotonin and noradrenaline reuptake inhibitors (SNRI) for stress urinary incontinence in adults. Cochrane Database Syst Rev 2005;2005(3):CD004742 «PMID: 16034945»PubMed
- Siddiqui F, Petersen JJ, Juul S, et al. Beneficial and harmful effects of duloxetine versus placebo, 'active placebo' or no intervention for adults with major depressive disorder: a systematic review with meta-analysis and trial sequential analysis of randomised clinical trials. BMJ Open 2025;15(2):e082853 «PMID: 39920066»PubMed