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Chapter 6 Methodology 2 Study process and data collection

6.5 Practice Period

The exercise regime was practiced for two weeks prior to each subsequent session. Miller et al (1998) used a practice period of seven days to allow for the acquisition of a new proprioceptive skill in The Knack (4.2.1.1). It was considered that a greater length of time may be necessary for subjects to become proprioceptively confident of the ability to selectively contract the PFM. Where 14 day scheduling was difficult for reasons of inconvenience for the subject, the subject was advised to practice for seven days following the first appointment and seven days before the second appointment in order that practice effect would be similar between subjects.

6.6 Posture

6.6.1 Supine

Supine examination posture was with knees bent and hips flexed at 60˚ with feet comfortably apart.Subjects were taught to find the neutral pelvic position with the spine maintained passively in a comfortable mid-range position between flexion and extension (Sapsford et al 2001).

6.6.2 Standing

Ultrasound assessment was performed in standing in Study 1 only, with feet comfortably apart and knees held comfortably straight.

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6.6.3 Standing position: methodological development

A factor that strongly influenced the decision to discontinue investigation of the standing posture was that both operator and subjects found the standing posture less acceptable than the supine posture due to issues of dignity. This stance was supported by the results that demonstrated that posture does not affect absolute AUI (Table 7.5a). This is further discussed in Chapter 8.5.

6.7 Attrition

6.7.1 Withdrawals

There were 11 withdrawals in Study 1 (Table 6.3) but none in Study 2 (Table 6.4) (see 8.4).

6.7.2 Exclusions

In Study 1, 12.5% of the subjects were unable to effectively perform a voluntary PFM contraction. In Study 2 this figure rose to 23% (Tables 6.3 and 6.4). With respect to inability to selectively contract, in Study 1, 13% were unable to

selectively contract and in Study 2 this figure was 7%. Exclusions are presented in Table 6.3 and Table 6.4. Description of the occupations of those excluded is presented in Table 6.5 (see also 8.4).

106 Table 6.3 Study 1: Attrition

Period Numbers Reason for Withdrawal/Unsuitability

Cooling 6 (19%) Hospital admission following RTA n=1

Reasons unknown n=5

After 1st session 9 (29%) Unable to perform a correct upward going voluntary PFMC n=4

Developed unacceptable low abdominal ache during the home exercise programme n=1

Felt the study was too invasive n=1

Reasons unknown n=3

After 2nd session 3 (13%) n=3 Unable to selectively contract the PFM as indicated by EMG

RTA= road traffic accident PFMC= pelvic floor muscle contraction EMG=Electromyographic

Table 6.4 Study 2: Attrition

Period Numbers Reason for Withdrawal/Unsuitability

Cooling n=0 N/A

After 1st session n=7 (23%) Unable to perform a correct upward voluntary PFMC

After 2nd session n=2 (8%) Unable to selectively contract the PFM as indicated by EMG

Table 6.5 Description of occupations in excluded subjects: Continent subjects Unsuitable for inclusion due to an

inability to perform a correct PFMC

Unsuitable for inclusion due to an inability to distinguish between compartments Non-health professionals n=19 n=2 (10%) n=2 (10%) Health Professionals n=13 n=2 (15%) (1 physiotherapist; 1 gynaecology nurse) n=1 (8%) (1 midwife)

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6.8 Data Collection

Introduction

Two-dimensional RTUS data was collected for Study 1 by CB at St Mark’s Hospital Harrow. KC was present to lead instructions. CB retired from NHS practice after Study 1 and may not have collected the data for Study 2. However consistency of operator was desirable due to variation in pressure applied to the probe between operators which can be an issue (Schaer 1996). Whilst having time constraints due to retirement, CB kindly agreed to collect a further 20 data sets in supine for the study at The Princess Grace Hospital in central London. A substantial amendment for this change was approved by HREC. Descriptions of age and BMI for the final data sets are presented in Tables 6.6 and 6.7

Table 6.6 Characteristics: continent subjects n=17

Health professionals n=9 Non health professionals n=8

Range Mean (SD) SD Ethnicity Age 24-47 34 5.39 BMI 18-36 24.7 4.08 Caucasian n=15 Asian n=1 Black African n=1

108 Table 6.7 Characteristics: incontinent subjects

n=21

(all non health professionals) Range Mean (SD) SD Ethnicity Age 51-69 55.61 5.10 BMI 21-34 26.54 3.06 *Parity 1-4 2.14 0.72 Heaviest baby (kg) 2.6 - 4.2 3.6 0.43 Years since delivery 6-35 19.19 8.06 Months since onset of

SUI 24-192 54.34 70.35 Forceps 2 Ventouse 1 Episiotomy 5 Tear only 8 Third or fourth degree tear 0 HRT 3 SUI 11 MUI 10 Faecal incontinence 0 Symptoms of POP 0 Caucasian n=20 Asian n=1

*Total number of deliveries in cohort n=46

BMI=body mass index HRT= hormone replacement therapy SUI= stress urinary incontinence MUI= mixed urinary incontinence

POP= pelvic organ prolapse

6.8.1 Bladder volume for data collection

Bladder volume was assessed immediately prior to data collection by CB using a trans abdominal approach. A minimum volume of 150 mls was the cut off point for scanning in order to clearly view the urethra and urethrovesical junction. Bladder volume varied from 25mls to 507 mls (mean 308; SD: 133). Early on in the study, two subjects did not have sufficient volume for scanning. They were asked to drink a further 400mls and were imaged again after one hour at which time each had sufficient volume for data collection. It was after this development that the change to the filling protocol was made as discussed previously in 6.2.2.

6.8.2 Ultrasound data collection

In random order each subject was asked to perform three brief maximal PFM contractions using each of the study cues to instruction (Table 6.2). The specific

109 study instructions only were used, and were only given once in order to avoid instruction/prompt bias between subjects. The peak of each contraction was captured on-screen. There was a 5 second rest between contractions. This process was repeated after 5 minutes for reliability purposes. This was performed in supine in Studies 1 and 2 and also in standing in Study 1. There was a five minute break between postures and repetition. Following data collection, three subjects accepted the invitiation to attend for pelvic floor physiotherapy (appendix 3a and 3b).

6.8.3 Cue preference

At the first session women were asked how they would normally perform a PFM contraction. The questions were asked (verbally): from around the front; from around the back; from the front and back together; from around the vagina and “other”. At the end of data collection (Session 3) the questions were repeated. Answers were recorded in the investigator notes for each subject. Results are presented in Table 7.9.

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