Gynecology Xagena

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Xagena Newsletter

One-to-one pelvic floor muscle training for prolapse is effective for improvement of symptoms in women with pelvic organ prolapse

Pelvic organ prolapse is common and is strongly associated with childbirth and increasing age. Women with prolapse are often advised to do pelvic floor muscle exercises, but evidence supporting the benefits of such exercises is scarce.

A study has assessed the effectiveness of one-to-one individualised pelvic floor muscle training for reducing prolapse symptoms.

A parallel-group, multicentre, randomised controlled trial at 23 centres in the UK, one in New Zealand, and one in Australia, during the period 2007-2010 was done.

Female outpatients with newly-diagnosed, symptomatic stage I, II, or III prolapse were randomly assigned ( 1:1 ), by remote computer allocation with minimisation, to receive an individualised programme of pelvic floor muscle training or a prolapse lifestyle advice leaflet and no muscle training ( control group ).
Outcome assessors, and investigators who were gynaecologists at trial sites, were masked to group allocation; the statistician was masked until after data analysis.

The primary endpoint was participants' self-report of prolapse symptoms at 12 months.

Analysis was by intention-to-treat analysis.

447 eligible patients were randomised to the intervention group ( n=225 ) or the control group ( n=222 ).

377 ( 84% ) participants completed follow-up for questionnaires at 6 months and 295 ( 66% ) for questionnaires at 12 months.

Women in the intervention group reported fewer prolapse symptoms ( ie, a significantly greater reduction in the pelvic organ prolapse symptom score [ POP-SS ] ) at 12 months than those in the control group ( mean reduction in POP-SS from baseline 3.77 vs 2.09; adjusted difference 1.52; p=0.0053 ).
Findings were robust to missing data.

Eight adverse events ( six vaginal symptoms, one case of back pain, and one case of abdominal pain ) and one unexpected serious adverse event, all in women from the intervention group, were regarded as unrelated to the intervention or to participation in the study.

In conclusion, one-to-one pelvic floor muscle training for prolapse is effective for improvement of prolapse symptoms. Long-term benefits should be investigated, as should the effects in specific subgroups. ( Xagena )

Hagen S et al, The Lancet 2014; 383; 796-806