In a systematic review including observational studies without control group, pessary-users had on average 57.6% leakage reduction in diaper tests at follow-up. However, it does not allow judgements of intervention effectiveness because of lack of control groups «Klein J, Stoddard M, Rardin C, et al. The Role of ...»1.
Only one randomized study measured the effectiveness of vaginal support (pessary) to reduce stress urinary incontinence symptoms. In the intervention group 14/18 (78%) and 11/34 (32%) in control group (standard care or pelvic muscle training) reported at least somewhat improved symptoms at 12 weeks follow-up «Lange S, Lange R, Tabibi E, et al. Comparison of V...»2.
Vaginal supports devises may cause some adverse events, the most common being pelvic floor discomfort and pain. Less common adverse effects were vaginal discharge and urogynecological infections «Klein J, Stoddard M, Rardin C, et al. The Role of ...»1.
| Reference | Study type | Population | Intervention and comparison | Outcomes | Risk of bias |
|---|---|---|---|---|---|
| «Klein J, Stoddard M, Rardin C, et al. The Role of ...»1 | SR/MA | Women (n=376), 52.2±5.4 years in age | Pessary use at baseline and follow up | Self-reported urinary incontinence, UDI-6, IIQ-7, Pad test, UCP | High |
| «Lange S, Lange R, Tabibi E, et al. Comparison of V...»2 | RCT | Women (n=54) with postpartum incontinence | Vaginal pessary group/ standard care/ Pelvic floor physiotherapy | Self-reported reduction in symptoms | High |
| RCT=randomized controlled trial; SR=systematic review; MA=meta-analysis | |||||
| Reference | Comments |
|---|---|
| «Klein J, Stoddard M, Rardin C, et al. The Role of ...»1 | No judgements on intervention effectiveness since there is no control group. |
| «Lange S, Lange R, Tabibi E, et al. Comparison of V...»2 | High risk of bias due to non-blinding of study participants and outcome assessment. |
Results
| Reference | Number of studies and number of patients (n) | Follow-up time | Number of patients | Event rate (feeling continent) (%) Feeling continent (%) |
Relative effect (95% CI) |
|---|---|---|---|---|---|
| Level of evidence: very low The quality of evidence is downgraded due to study limitations, imprecision and indirectness. The results are not fully applicable to the national context, as the vaginal support devices used in the studies are not necessarily the same as those used in Finland. I=intervention; C=comparison; CI=confidence interval; P=pessary; SC=standard care; PFMT=pelvic floor muscle training *Calculated from even rates |
|||||
| «Klein J, Stoddard M, Rardin C, et al. The Role of ...»1 | 2 studies (86) | <6 month | 86 | 72 (76%) | N/A |
| «Lange S, Lange R, Tabibi E, et al. Comparison of V...»2 | 54 patients | 12 week | P: 18 SC: 17 PMFT: 17 |
P: 14/18 (77,8%) SC: 7/17 (41,2%) PFMT: 4/17 (23,5%) |
RR 2.4 (1.4 to 4.1) in favor of pessary* |
| Reference | Number of studies and number of patients (n) | Follow-up time | Follow-up (n) decreased pad weight % |
Mean difference (95% CI) |
|---|---|---|---|---|
| Level of evidence: very low The quality of evidence is downgraded due to study limitations. I=intervention; C=comparison; CI=confidence interval |
||||
| «Klein J, Stoddard M, Rardin C, et al. The Role of ...»1 | 3 studies (129) | <6 months | (118) -57,6% | - |
| Reference | Number of studies and number of patients (n) | Follow-up time | Follow-up (n) Increased urethral closure % |
Mean difference (95% CI) |
|---|---|---|---|---|
| Level of evidence: low Assess the risk of bias and delete irrelevant sources of bias: The quality of evidence is downgraded due to study limitations. |
||||
| «Klein J, Stoddard M, Rardin C, et al. The Role of ...»1 | 3 studies (122) | <6 months | (122) 33% | (-0,66–1,77) |