Baessler 2019.
| Study characteristics | ||
| Methods | Design: two‐arm parallel RCT | |
| Participants |
Country: Germany Number of participants: 34 Mean age: pessary group 32 (SD 5.6); standard care 30.4 (SD 6.6) Prolapse staging: stage II Prolapse compartment: anterior and posterior Inclusion criteria: women 18 and over, first vaginal delivery, stage 2 POP (examination or perineal ultrasound in standing position) Exclusion criteria: severe diseases of mother/child, previous pelvic surgery, neurological diseases, severe perineal post partum pain, high vaginal tears |
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| Interventions |
Group I (n = 13): vaginal ring pessary Group II (n = 21): standard care (no interventions for six weeks postpartum) |
|
| Outcomes |
Primary outcome: prolapse symptoms measured using the Australian Pelvic Floor Questionnaire (German version with validated postpartum module) at 12 months Secondary outcomes: POP‐Q, pelvic ultrasound for bladder neck and puborectalis at rest and on straining in standing |
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| Notes |
Funding source: not reported Declarations of interest: J Stupin discloses Arabin GmbH: Consultant, all other authors state they have noting to disclose. Trial stopped early due to poor recruitment and 'occasional pessary problems which were solved with pessary removal' |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | PC‐generated randomisation list put into opaque envelopes. Preference was permitted but data are available for randomised group only |
| Allocation concealment (selection bias) | Low risk | Opaque envelopes opened after consent and examination for levator avulsion |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Not possible to blind participant or caregiver. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Assessors blinded to group allocation. |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Some differential loss to follow‐up (1/13 in pessary group, 6/21 in standard care group). |
| Selective reporting (reporting bias) | Low risk | Data provided on measured outcomes. |
| Other bias | Low risk | None |