Can primary care nurse administered pelvic floor muscle training (PFMT) be implemented for the prevention and treatment of urinary incontinence? A study protocol

Implementation process (populations)

The study will comprise of two populations – a prevention group and a treatment group (see Figure 1 for a flow diagram of the study design). Women will be allocated to either of these two groups (following gathering of baseline data and assessment of their pelvic floor muscle strength) as follows:

1. Prevention group - Women aged 25–64 years who have had at least one vaginal birth (i.e. parous women) attending their GP surgery for a routine cervical smear. This group will be further subdivided into a primary prevention arm and a secondary prevention arm following the information provided from the completion of the baseline data form at the time of the smear:

a) Primary prevention arm - Women with no symptoms of urinary incontinence but a weak Modified Oxford Scale score (≤ 2).

b) Secondary prevention arm - Women symptomatic of mild (i.e. not bothersome) urinary incontinence who have not previously sought medical treatment from their GP for UI irrespective of Modified Oxford Scale score.

2. Treatment group - Women over the age of 18 years who may or may not have experienced a vaginal birth presenting at their GP surgery with urinary incontinence.

Figure 1. Can primary care nurse administered pelvic floor muscle training (PFMT) be implemented for the prevention and treatment of urinary incontinence? Flow diagram of study design.

Inclusion criteria

Women (aged over 18) from the primary prevention group who have a score of two or less on the Modified Oxford Scale and all women from the secondary prevention and treatment groups irrespective of their Modified Oxford Scale score will be eligible for the study.

Exclusion criteria

Women under 18, and those over 18, but unable to speak English or who have special communication needs will be excluded from the study. Patients who have evidence of urinary infection, pelvic pain, blood on urinalysis, visible prolapse, pelvic mass, voiding difficulties or other abnormalities will also be excluded.

Implementation process (training of professionals and localities)

NHS Plymouth has 41 GP practices in 5 geographic localities with around 230 fully trained smear takers who are mostly practice nurses. They undertake approximately 16,000 cervical smears every year. In order to implement the delivery of PFMT in primary care, cervical smear takers will need to be trained to undertake pelvic floor assessment and deliver PFMT to women tailored to individual need. Such training will include gaining an understanding of the principles involved in pelvic floor muscle assessment including digital vaginal palpation known as the Modified Oxford Scale score. At the end of this training they will be able to assess pelvic floor muscle condition, be able to advise the patient on an individual programme of exercise and to set targets for that exercise.

Training will be staggered between localities in order for subsequent evaluation to take place on a rolling basis. Two localities with differing social class demographics will be chosen for initial training roll-out. By doing this, it may be possible to ascertain whether barriers and facilitators relating to the delivery of PFMT in primary care differ by socio-economic status. For the purposes of this evaluation, socio-economic status will be measured by occupation and postcode.

Implementation evaluation

The evaluation of implementation will be undertaken by the Collaboration for Leadership and Applied Health Research and Care for the South West Peninsula (PenCLAHRC). The study will assess the following outcome measures.

Primary outcome measure

Reduce cost by fewer referrals to secondary care. For the treatment group, to assess whether delivering PFMT in primary care results in fewer referrals to secondary care, thereby reducing the number and associated costs of surgical procedures for UI. This is in keeping with the QIPP agenda (a large scale transformational programme for the NHS, involving all staff aimed at improving the quality of care the NHS delivers whilst making up to £20 billion of savings by 2015 to be reinvested in frontline care).

Secondary outcome measures

Patient satisfaction. As a marker of service quality, patient satisfaction of practice nurse delivered PFMT will be assessed at the end of PFMT training through the completion of a modified Royal College of General Practitioners (RCGP) Short-Form Patient Satisfaction Questionnaire (PSQ-18) by all women who have been recruited to PFMT training.

Compliance and default rates

Compliance and default rates with PFMT training in the treatment group will be monitored against both sub-groups in the prevention group through attendance at follow-up consultations. Each woman will be offered at least one follow-up consultation three months after the commencement of PFMT training either by telephone or face-to-face depending on preference. Training will be reviewed and further measures for improvement will be suggested if necessary. Follow-up data will be collected using a data collection sheet that will repeat the modified questions from the International Consultation on Incontinence Questionnaire (ICI-Q) completed at baseline (see Questionnaire files). The responses will allow us to ascertain if there have been any changes to the symptoms of UI and indicate levels of compliance with PFMT training offered at baseline. If the woman would like to continue with follow-up after her first follow-up consultation then she will be allowed to do so for a maximum of three further occasions at three monthly intervals.

Clinical measures

Clinical outcomes will examine whether patient-reported symptoms of UI are improved after a course of primary care nurse-delivered PFMT, through the completion of a modified ICI-Q Short Form (SF) questionnaire at baseline and at each follow-up (see Questionnaire files). This data will also allow us to establish the prevalence of low grade urinary incontinence and the general pelvic floor muscle condition in the female population in Plymouth.

Semi-structured, in-depth interviews will be carried out by an experienced qualitative researcher with a sample of patients and practice nurses, receiving or delivering PFMT in primary care in order to identify facilitators and barriers to implementation. It is hoped that 60 interviews will be conducted in total, with as far as possible equal numbers from all three groups. Women who refuse PFMT training will also be approached for interview in order to further understand barriers and facilitators to delivering PFMT in primary care.

Once interview transcripts have been analysed, a matrix will be designed which will enable us to ascertain key themes and create an understanding of the individual and group coding. The interviews will add depth to the analysis of quantitative (baseline and follow-up) data.