Cheung 2016.
Study characteristics | ||
Methods |
Design: parallel group RCT Dates study conducted: December 2011 to November 2014 |
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Participants |
Setting: Hong Kong, single centre Number of participants: 276 women with pelvic organ prolapse stages I to III (POPQ) Mean age: PFMT group 62.7 (SD 10.2); pessary group 62.5 (SD 9.1) Prolapse staging: PFMT group: stage I n = 14 (10%); stage II n = 92 (67%); stage III n = 31 (23%) Pessary group: stage I n = 11 (8%), stage II n = 96 (69%) stage III n = 32 (23%) Prolapse compartment: PFMT group: anterior n = 91 (61.4%); apical n = 38 (27.7%); posterior n = 8 (5.8%) Pessary group: anterior n = 90 (64.7%); apical n = 45 (32.4%); posterior n = 4 (2.9%) Inclusion criteria: symptomatic pelvic organ prolapse stage I to III (POP‐Q), no previous treatment Exclusion criteria: complications that arise from prolapse, confirmed urinary retention, vaginal erosion or ulcer that required active treatment, impaired mobility, cognitive impairment, language barrier that prevented questionnaire completion |
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Interventions |
Group I (n = 137): PFMT treatment alone Group II (n = 139): vaginal ring pessary plus conservative treatment |
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Outcomes |
Primary outcome: PFDI and PFIQ plus subscales Secondary outcome: discomfort from prolapse symptoms (VAS score), desired treatment, complications |
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Notes |
Funding source: not reported Declarations of interest: quote: "The authors did not report any potential conflicts of interest" |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Women randomised using random computer‐generated numbers and allocated in serially numbered envelopes. |
Allocation concealment (selection bias) | Low risk | Allocated by random number series |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants not blinded to treatment. Investigator who took history and recorded POP‐Q blinded to group allocation. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Primary outcome self‐completion. Investigator who took history and recorded POP‐Q blinded to group allocation. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 135/139 in pessary group and 130/137 in PFMT alone group completed measures at 12 months. |
Selective reporting (reporting bias) | Low risk | Not all outcomes listed in Trial registry and paper presented but main outcomes are presented and they have reported outcomes of interest to this review |
Other bias | Low risk | None. |