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. 2020 Nov 18;2020(11):CD004010. doi: 10.1002/14651858.CD004010.pub4

Cheung 2016.

Study characteristics
Methods Design: parallel group RCT
Dates study conducted: December 2011 to November 2014
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
Interventions Group I (n = 137): PFMT treatment alone
Group II (n = 139): vaginal ring pessary plus conservative treatment
Outcomes Primary outcome: PFDI and PFIQ plus subscales
Secondary outcome: discomfort from prolapse symptoms (VAS score), desired treatment, complications
Notes Funding source: not reported
Declarations of interest: quote: "The authors did not report any potential conflicts of interest"
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.