In a Cochrane review «Simunić V, Banović I, Ciglar S, et al. Local estro...»1, 3 small trials measured the effect of topical estrogen therapy on number of voids per day and nocturia. Although the studies were placebo controlled, they were incompletely reported leading to high risk of bias.
One large placebo-controlled study «Cody JD, Jacobs ML, Richardson K, et al. Oestrogen...»2 measured the effect of topical estrogen on urogenital symptoms. Although it suggested large effects in decreasing the number of patients having incontinence symptoms, composite outcomes (including measures probably not relevant to patients) and dichotomized continuous outcomes do not allow judgements of clinical relevance.
| Reference | Study type | Population | Intervention and comparison | Outcomes | Risk of bias |
|---|---|---|---|---|---|
| RCT=randomized controlled trial; SR=systematic review; MA=meta-analysis | |||||
| «Simunić V, Banović I, Ciglar S, et al. Local estro...»1 | RCT | Postmenopausal women with urogenital complaints | Vaginal estriol tablets once a a day for 2 weeks, followed by twice a week for 12
months vs. placebo |
Urge incontinence, nocturia/frequent voiding, dysuria, total score for symptoms and clinical findings | High |
| «Cody JD, Jacobs ML, Richardson K, et al. Oestrogen...»2 | SR/MA | Women with symptomatic or urodynamic diagnoses of stress, urgency or mixed urinary incontinence or other urinary symptoms post-menopause | Local estrogen vs placebo (4 trials) | Number of voids per 24 hours, nocturia | High |
| Reference | Comments |
|---|---|
| «Simunić V, Banović I, Ciglar S, et al. Local estro...»1 | Inclusion criteria: women with urogenital complains (not further defined). Outcome assessment is incompletely described. Urge incontinence was defined as an involuntary loss of urine with a strong desire to void in a survey. Unclear how many episodes and in what timeline to be counted as an event. Risk of bias: allocation concealment not described, blinding not described loss to follow up unclear. ITT analysis was probably not used. |
| «Cody JD, Jacobs ML, Richardson K, et al. Oestrogen...»2 | All included studies were placebo controlled but badly reported leading to unclear/high risk of bias. One of the four studies included measured the effect of intravesical treatment and had the largest treatment effect. |
Results
| Reference | Number of studies and number of patients (I/C) | Follow-up time | Mean (sd) I | Mean (sd) C | Mean difference (95% CI) |
|---|---|---|---|---|---|
| Level of evidence: very low The quality of evidence is downgraded due to study limitations, inconsistency and imprecision. I=intervention; C=comparison; CI=confidence interval |
|||||
| «Cody JD, Jacobs ML, Richardson K, et al. Oestrogen...»2 | 4 studies, 71/41 | - | not reported, range 5.2-9.6 | range 6.3-7.9 | fixed effects, -1.8 (-2.58 to -1.03) |
| Reference | Number of studies and number of patients (I/C) | Follow-up time | Mean (sd) I | Mean (sd) C | Mean difference (95% CI) |
|---|---|---|---|---|---|
| Level of evidence: very low The quality of evidence is downgraded due to study limitations, imprecision and indirectness (one of the studies tested intravesical treatment). |
|||||
| «Cody JD, Jacobs ML, Richardson K, et al. Oestrogen...»2 | 3 studies (51/31) | - | not reported, range 1.3-3.1 | range 3.3-5 | fixed effects -2.03 (-2.82 to -1.24) |
| Reference | Number of studies and number of patients (I/C) | Follow-up time | Number of events (%) I | Number of events (%) C | Relative risk (95% CI) |
|---|---|---|---|---|---|
| *Not calculated in the study Level of evidence: low The quality of evidence is downgraded due to study limitations and indirectness (outcome description was unclear and could be less relevant to patients). I=intervention; C=comparison; CI=confidence interval |
|||||
| «Simunić V, Banović I, Ciglar S, et al. Local estro...»1 | 1 study (828/784) | 12 months | 106 (12.8%) | 175 (22.8%) | 0.57 (0.46-0.72)* |