Pelvic floor muscle training as an adjunct to prolapse surgery: a randomised feasibility study.
OBJECTIVE
There is evidence that in nonsurgical populations, pelvic floor muscle training (PFMT) and lifestyle advice improves symptoms and stage of pelvic organ prolapse (POP). Some women, however, require surgery, after which de novo symptoms can develop or additional surgery is required due to recurrence. Robust evidence is required as to the benefit of perioperative PFMT in the postsurgery reduction of symptoms and POP recurrence. The aim of this study was to assess the feasibility of and collect pilot data to inform sample size (SS) calculation for a multicentre randomised controlled trial (RCT) of perioperative PFMT following surgical intervention for POP.


METHODS
Fifty-seven participants were recruited and randomised to a treatment group (one pre and six postoperative PFMT sessions) or a control group (usual care). The primary outcome measure was the Pelvic Organ Prolapse Symptom Score (POP-SS) at 12 months; secondary outcome measures included measurement of prolapse, the pelvic floor and questionnaires relating to urinary and bowel incontinence. All outcomes were measured at 0, 6 and 12 months.


RESULTS
Information on recruitment, retention and appropriateness of outcome measures for a definitive trial was gathered, and data enabled us to undertake an SS calculation. When compared with the control group (n = 29), benefits to the intervention group (n = 28) were observed in terms of fewer prolapse symptoms at 12 months [mean difference 3.94; 95 % confidence interval (CI) 1.35-6.75; t = 3.24, p = 0.006]; however, these results must be viewed with caution due to possible selection bias.


CONCLUSIONS
With modifications to design identified in this pilot study, a multicentre RCT is feasible.
Nursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow, G40BA, UK, Doreen.McClurg@gcu.ac.uk.
Doreen
D
McClurg
Paul
P
Hilton
Lucia
L
Dolan
Ash
A
Monga
Suzanne
S
Hagen
Helena
H
Frawley
Lucy
L
Dickinson
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005081:Exercise Therapy; D005240:Feasibility Studies; D005242:Fecal Incontinence / Q000209:etiology; D005260:Female; D006801:Humans; D008875:Middle Aged; D053580:Muscle Strength; D010349:Patient Compliance; D018579:Patient Selection; D017773:Pelvic Floor / Q000503:physiopathology*; D056887:Pelvic Organ Prolapse / Q000503:physiopathology / Q000628:therapy*; D011182:Postoperative Care; D011300:Preoperative Care; D012107:Research Design; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D014549:Urinary Incontinence / Q000209:etiology