Hypothesis / aims of study
Evidence exists that pelvic floor muscle training (PFMT) is effective for the treatment of prolapse symptoms (1). In the UK, the recently-updated NICE guidelines (https://www.nice.org.uk/guidance/ng123/chapter/Recommendations#non-surgical-management-of-pelvic-organ-prolapse) recommend considering a programme of supervised PFMT for at least 16 weeks as a first option for women with symptomatic prolapse (stage I or stage II). In most trials to date evaluating the effects of PFMT for prolapse, the PFMT has been delivered by specialist physiotherapists. However, in the UK the number of specialist physiotherapists is limited and insufficient to deliver the necessary treatment for the 5-10% of women likely to experience symptomatic prolapse (1). We undertook an implementation study to investigate what service models the UK NHS might use to ensure wide availability of PFMT, and how different models would impact on women’s treatment outcomes.
Study design, materials and methods
Informed by the realist evaluation framework, the study used a longitudinal multiple case study design, in four diverse NHS centres. With support from the study team, the centres developed and implemented a model of PFMT delivery suited to their local context, workforce and resources. These were compared with a fifth NHS centre where a specialist pelvic floor physiotherapy service was already available. Women were recruited in all five centres to an observational prospective cohort study to assess their prolapse symptoms at baseline, 6 and 12 months. Participants were aged ≥ 18 years, presenting with symptomatic stage I, II or III prolapse of any type, and were suitable to be referred for PFMT. Women were excluded if they were pregnant or <1 year postnatal, had pelvic cancer, cognitive impairment or neurological disease. The primary outcome was the Pelvic Organ Prolapse Symptom Score (POP-SS) (7 items scoring frequency of different prolapse symptoms, range 0 to 28, higher scores indicating greater symptom severity) (2). Assuming a minimum clinically important difference in the POP-SS of 2 points and standard deviation (SD) of the difference between baseline and follow-up of 5.5 points (3), a sample size of 120 would provide 80% power to detect important differences. Analyses: 1) paired t-tests were conducted to compare POP-SS at baseline with those at follow-up, and 2) independent-samples t-tests were used to compare the mean change in POP-SS from baseline to follow-up for women treated by a specialist physiotherapist with those treated by other healthcare professionals (HCPs). Analyses 1) and 2) were then built upon by fitting linear mixed models to adjust for covariates (including ethnicity, parity, age and BMI). A 5% significance level was used throughout.
Service models: The models for delivering PFMT adopted by the different centres consisted of a mix of different staff types (specialist and non-specialist physiotherapists and nurses) and grades (Band 5, 6 and 7). All centres, except one, had a model whereby women were initially triaged into the service by a specialist or consultant.
Staff training: A one-day prolapse training course developed for the study was attended by all staff delivering treatment to participants in the study centres. It was delivered by an experienced pelvic health physiotherapist and workshop tutors from the Pelvic, Obstetric and Gynaecological Physiotherapy Professional Network of the Chartered Society of Physiotherapy, and covered assessment and treatment, with pre-attendance learning material and additional resources provided.
Recruitment: 102 women were recruited. Baseline questionnaires were available from 91 women, and 71 women completed the 6-month follow-up questionnaire, for whom 68 questionnaires were matched to baseline questionnaires. There were 31 completed questionnaires at 12 months, of which 30 were matched to baseline. The mean age of participants was 57.5 years (SD 11.5), and mean BMI was 27.1 (SD 4.6). One woman was nulliparous, and the majority of parous women (n=38, 16.5%) had had two births.
Women’s outcomes at 6 and 12 months: These was a significant improvement in POP-SS score between baseline and 6 months in the whole cohort (mean difference -3.20 [95% CI -4.40 to -2.00]) (Table 1) which was confirmed in the linear mixed model adjusting for covariates (effect estimate –3.48 [95% CI –4.93 to –2.04]). Comparing the improvement in POP-SS from baseline to 6 months between those treated by a specialist physiotherapist and those treated by another HCP showed no significant difference (mean difference 0.39 [-1.41 to 3.69]) (Table 2) and this was confirmed after adjusting for covariates (effect estimate 0.05 [95% CI -2.59 to 2.69]). There was also a significant improvement in POP-SS score for the whole cohort from baseline to 12 months (mean difference -2.73 [95% CI -4.48 to -0.99]). Limited further analysis was carried out on the 12-month data however, due to the reduced sample size.
Interpretation of results
We found that women having PFMT for prolapse had improved symptoms after 6 months, and the magnitude of improvement was similar to the effect observed in a trial context (effect estimate for change in POP-SS: -2·84 [2·05–3·63], p<0·0001)(3). In addition, there was no difference in the improvement in symptoms obtained from PFMT delivery by specialist physiotherapists compared with PFMT delivery by other HCPs, suggesting implementation via different models in the “real world” is feasible. It seems there is scope for other members of the healthcare team, with appropriate training and support, to deliver PFMT safely and effectively. Although the number of women recruited was lower than anticipated, with additional attrition by 12 months, and varying recruitment rates across centres, the sample size was sufficient to enable the key research questions to be answered.