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MacArthur C, Bick D, Salmon V, et al. Midwifery-led antenatal pelvic floor muscle exercise intervention to reduce postnatal urinary incontinence: APPEAL research programme including a feasibility and pilot cluster RCT. Southampton (UK): National Institute for Health and Care Research; 2024 Nov. (Programme Grants for Applied Research, No. 12.09.)

Cover of Midwifery-led antenatal pelvic floor muscle exercise intervention to reduce postnatal urinary incontinence: APPEAL research programme including a feasibility and pilot cluster RCT

Midwifery-led antenatal pelvic floor muscle exercise intervention to reduce postnatal urinary incontinence: APPEAL research programme including a feasibility and pilot cluster RCT.

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Appendix 4Additional work package 4.2 tables

TABLE 9

General information on sending/receiving women’s questionnaire

Number of women in the database 1304
Number of women in the database who received maternity care from one of the midwifery teams randomised to APPEAL1005
Number of out of area women in the database269
Number of new team’sa women in the database4
Number of women in the database for whom no midwifery team recorded26
Number of women to whom the questionnaire was sent 1294 b
Number of women to whom the questionnaire was sent, who received maternity care from one of the midwifery teams randomised to APPEAL998
Number of out of area women to whom the questionnaire was sent266
Number of new team’sa women to whom the questionnaire was sent4
Number of women to whom the questionnaire was sent but no midwifery team recorded26
Number of women who returned the questionnaire 231
Number of women who returned the questionnaire, who received maternity care from one of the midwifery teams randomised to APPEAL175
Number of out of area women who returned the questionnaire56
Number of new team’sa women who returned the questionnaire0
Number of women to whom the short, translated version of the questionnaire was sent 111
Number of women to whom the short, translated version of the questionnaire was sent, who received maternity care from one of the midwifery teams randomised to APPEAL90
Number of out of area women to whom the short, translated version of the questionnaire was sent17
Number of new team’sa women to whom the short, translated version of the questionnaire was sent3
Number of women to whom the short, translated version of the questionnaire was sent but no midwifery team recorded1
Number of women who returned the short, translated version of the questionnaire 10
Number of women who returned the short, translated version of the questionnaire and who received maternity care from one of the midwifery teams randomised to APPEAL8
Number of out of area women who returned the short, translated version of the questionnaire2
Number of new team’sa women who returned the short, translated version of the questionnaire0
Number of women to whom the standard questionnaire was sent 1179
Number of women to whom the standard questionnaire was sent, who received maternity care from one of the midwifery teams randomised to APPEAL905
Number of out of area women to whom the standard questionnaire was sent248
Number of new team’sa women to whom the standard questionnaire was sent1
Number of women to whom the standard questionnaire was sent but no midwifery team recorded25
Number of women who returned the standard questionnaire 221
Number of women who returned the standard questionnaire and who received maternity care from one of the midwifery teams randomised to APPEAL167
Number of out of area women who returned the standard questionnaire54
Number of new team’sa women who returned the standard questionnaire0
a

A new continuity of care team was created in the last month of the trial.

b

296 women have been excluded from the analysis because either they did not receive maternity care from any of the midwifery teams randomised to APPEAL or the midwifery team name was not reported.

TABLE 10

Information on sending/receiving women’s questionnaire by group

Intervention (N = 531)Control (N = 467)Overall (N = 998)
Number of women to whom the questionnaire was sent531467998
Number of women to whom the short, translated version of the questionnaire was sent523890
Number of women to whom the standard questionnaire was sent479426905
Number of women to whom the questionnaire was sent one time9876174
Number of women to whom the questionnaire was sent one time, who returned the questionnaire6248110
Number of women to whom the questionnaire was sent two times433391824
Number of women to whom the questionnaire was sent two times, who returned the questionnaire263965
Total number of questionnaires returned8887175
Number of women who returned the short questionnaire538
Number of women who returned the standard questionnaire8384167
Number of women recorded on the database and the questionnaire was not sent to thema:617
a

The questionnaire was not sent to these women due to serious health issues; see Table 11.

TABLE 11

Details on women’s exclusion

Site 1Site 2
Stillbirth00
Neonatal death05
Infant death01
Fetal abnormality10
Women whose infants were taken into care due to safeguarding concerns10
Women who have severe mental health problems80
Restricted address10
Twin pregnancy – one twin intrauterine death01

TABLE 12

Minimisation variables used in the randomisation by group and overall

Minimisation variablesWomen who returned questionnaireWomen who did not return questionnaire
Intervention (N = 88), n (%)Control (N = 87), n (%)Overall (N = 175), n (%)Overall (N = 823), n (%)
Midwifery team sizeSmall35 (39.8)25 (28.7)60 (34.3)276 (33.5)
Large53 (60.2)62 (71.3)115 (65.7)547 (66.5)
TrustSite 146 (52.3)23 (26.4)69 (39.4)300 (36.5)
Site 242 (47.7)64 (73.6)106 (60.6)523 (63.5)

TABLE 13

Other baseline characteristics by group and overall

Women who returned questionnaireWomen who did not return questionnaire
Intervention (N = 88)Control (N = 87)Overall (N = 175)Overall (N = 1063)
Women’s demographics and other baseline characteristics
Maternal
Age, years n 78771551063
Mean (SD)31.6 (4.9)31.9 (5.5)31.8 (5.2)29.6 (N/Aa)
Minimum, maximum22, 4519, 4819, 4815, 46
Median (IQR)32 (28–35)32 (29–35)32 (28–35)Ν/Αa
Missing1010200
Ethnicity n 88871751063
British40 (52.0%)37 (48.1%)77 (50.0%)371 (34.9%)
Irish1 (1.3%)0 (0%)1 (0.7%)5 (0.5%)
White other5 (6.5%)1 (1.3%)6 (3.9%)46 (4.3%)
White and Black Caribbean0 (0%)0 (0%)0 (0%)11 (1.0%)
White and Black African0 (0%)0 (0%)0 (0%)4 (0.4%)
White and Asian0 (0%)0 (0%)0 (0%)5 (0.5%)
Mixed other0 (0%)0 (0%)0 (0%)8 (0.8%)
Indian0 (0%)3 (3.9%)3 (2.0%)33 (3.1%)
Pakistani3 (3.9%)7 (9.1%)10 (6.5%)205 (19.3%)
Bangladeshi2 (2.6%)0 (0%)2 (1.3%)16 (1.5%)
Asian other6 (7.8%)7 (9.1%)13 (8.4%)29 (2.7%)
Black Caribbean0 (0%)1 (1.3%)1 (0.7%)10 (0.9%)
Black African1 (1.3%)1 (1.3%)2 (1.3%)37 (3.5%)
Black other3 (3.9%)1 (1.3%)4 (2.6%)16 (1.5%)
Chinese0 (0%)0 (0%)0 (0%)6 (0.6%)
Any other ethnic group6 (7.8%)1 (1.3%)7 (4.6%)56 (5.3%)
Not stated6 (7.8%)4 (5.2%)10 (6.5%)193 (18.2%)
Declined to answer0 (0%)0 (0%)0 (0%)0 (0%)
Not known4 (5.2%)14 (18.2%)18 (11.7%)12 (1.1%)
Missing1110210
Parity n 88871751063
034 (45.3%)28 (36.8%)62 (41.0%)367 (34.5%)
128 (37.3%)33 (43.4%)61 (40.4%)317 (29.8%)
29 (12.0%)7 (9.2%)16 (10.6%)181 (17.0%)
34 (5.4%)5 (6.6%)9 (6.0%)91 (8.6%)
40 (0%)1 (1.4%)1 (0.7%)35 (3.3%)
5 or more0 (0%)2 (2.6%)2 (1.3%)72 (6.8%)
Missing1311240
Obstetric
Onset of labour n 88871751063
Spontaneous42 (55.3%)39 (50.0%)81 (52.6%)429 (41.7%)
Induced12 (15.8%)23 (29.5%)35 (22.7%)307 (29.8%)
N/A – elective caesarean section (including failed induction)22 (28.9%)16 (20.5%)38 (24.7%)293 (28.5%)
Missing1292134
Mode of birth n 88871751063
Ventouse10 (13.3%)11 (14.1%)21 (13.7%)61 (5.7%)
Forceps4 (5.3%)4 (5.1%)8 (5.2%)49 (4.6%)
Caesarean section26 (34.7%)24 (30.8%)50 (32.7%)405 (38.1%)
Spontaneous vaginal birth35 (46.7%)39 (50.0%)74 (48.4%)547 (51.5%)
Missing139221
Anaestheticb n 88871751063
Spinal23 (79.3%)23 (76.7%)46 (78.0%)345 (69.4%)
Epidural5 (17.2%)7 (23.3%)12 (20.3%)122 (24.5%)
General1 (3.5%)0 (0%)1 (1.7%)30 (6.0%)
Missing5957116566
Analgesiac n 88871751063
Yes39 (72.2%)50 (80.7%)89 (76.7%)524 (49.3%)
No15 (27.8%)12 (19.3%)27 (23.3%)539 (50.7%)
Missing3425590
Perineal trauma n 88871751063
First degree6 (8.3%)7 (9.1%)13 (8.7%)86 (15.2%)
Second degree21 (29.2%)27 (35.1%)48 (32.2%)223 (39.5%)
3a1 (1.4%)1 (1.3%)2 (1.3%)5 (0.9%)
3b1 (1.4%)0 (0%)1 (0.7%)2 (0.4%)
3c1 (1.4%)0 (0%)1 (0.7%)0 (0%)
Fourth degree0 (0%)0 (0%)0 (0%)1 (0.2%)
Labial lacerations0 (0%)0 (0%)0 (0%)0 (0%)
None42 (58.3%)42 (54.5%)84 (56.4%)248 (43.9%)
Missing161026498
Episiotomy n 88871751063
Yes17 (23.3%)16 (21.1%)33 (22.2%)143 (24.0%)
No56 (76.7%)60 (78.9%)116 (77.8%)453 (76.0%)
Missing151126467
Duration of second stage (minutes) n 263763809
Minimum, maximum0, 12600, 18600, 18600, 300
Median (IQR)35 (2–143)36 (10–77)36 (8–94)Ν/Αa
Missing6250112254
Infants
Gestation at birth (weeks) n 78781561063
Mean (SD)39.6 (1.6)39.3 (2.2)39.4 (1.9)36.0 (N/Aa)
Minimum, maximum34.6, 42.124.1, 41.924.1, 42.123.0, 42.0
Missing109190
Birthweight (g) n 78781561063
Mean (SD)3356 (435)3325 (499)3340 (467)3171 (N/Aa)
Minimum, maximum2170, 4550700, 4150700, 4550550, 4850
Missing109190
Head circumference (cm) n 73741471015
Mean (SD)34.5 (1.3)34.2 (1.2)34.4 (1.2)33.3 (N/Aa)
Minimum, maximum32.0, 38.030.5, 36.530.5, 38.021.0, 52.0
Missing15132848
a

The two sites were unable to provide this number.

b

Women can have a combination of anaesthetic methods or none. The specific types of each method have not been reported.

c

Types of analgesia used: APPEAL intervention: aromatherapy, combined spinal and epidural, paracetamol, pethidine, paracetamol codeine, codeine, diamorphine, Entonox®, TENS, birthing pool, gas and air. Standard care: epidural, combined spinal and epidural, pethidine, paracetamol, codeine, Entonox, TENS, birthing pool.

TABLE 14

Prevalence of UI at 10–12 weeks using ICIQ-UI SF40, EARS43 and PFMESES42

Prevalence of UI using the ICIQ-UI SFIntervention (n = 88)Control (n = 87)
Total ICIQ-UI SF scorea N 8786
Mean (SD)3.3 (4.5)4.2 (4.3)
Missing11
95% CI2.1 to 4.5b2.9 to 5.6c
How often do you leak urine?Never49 (55.7%)40 (46.0%)
About once a week or less22 (25.0%)21 (24.1%)
Two or three times a week8 (9.0%)15 (17.2%)
About once a day5 (5.7%)4 (4.6%)
Several times a day2 (2.3%)7 (8.1%)
All of the time2 (2.3%)0 (0%)
Missing00
How much urine do you usually leak (whether you wear protection or not)?None49 (53.3%)36 (41.8%)
A small amount35 (40.2%)44 (51.2%)
A moderate amount3 (23.5%)6 (7.0%)
A large amount0 (0%)0 (0%)
Missing11
Overall, how much does leaking urine interfere with your everyday life? Please tick a number between 0 (not at all) and 10 (a great deal)053 (60.2%)39 (45.3%)
16 (6.8%)10 (11.6%)
25 (5.7%)9 (10.5%)
38 (9.1%)10 (11.6%)
43 (3.4%)4 (4.7%)
56 (6.8%)6 (7.0%)
60 (0%)4 (4.7%)
72 (2.3%)2 (2.3%)
83 (3.4%)0 (0%)
90 (0%)0 (0%)
102 (2.3%)2 (2.3%)
Missing01
When does urine leak?dNever – urine does not leak47 (53.4%)36 (41.4%)
Leaks before you can get to the toilet16 (18.2%)25 (28.7%)
Leaks when you sneeze25 (28.4%)34 (39.1%)
Leaks when you are asleep1 (1.1%)4 (4.6%)
Leaks when you are physically active/exercising20 (22.7%)21 (24.1%)
Leaks when you have finished urinating and are getting dressed7 (8.0%)11 (12.6%)
Leaks for no obvious reason5 (5.7%)3 (3.5%)
Leaks all of the time1 (1.1%)2 (2.3%)
Missing01
Prevalence of UIeYes39 (44.3%)47 (54.0%)
No49 (55.7%)40 (46.0%)
Missing00
95% CI32.0% to 56.1%f42.2% to 65.8%g
Women’s EARS score N 8282
Mean (SD)10.8 (5.6)9.4 (5.4)
Missing65
95% CI9.1 to 12.4f5.3 to 15.0g
Total score of self-efficacy (PFMESES): women’s confidence in their practice of performing PFMEh N 1922
Mean (SD)65.7 (9.1)65.6 (8.1)
Missing6965
95% CI58.0 to 73.2e61.0 to 70.3f
Subscore of self-efficacy (PFMESES): women’s belief in PFME execution and its benefitsi N 7976
Mean (SD)41.6 (7.5)41.6 (6.8)
Missing911
95% CI38.9 to 44.2e37.9 to 45.4f
Subscore sum of self-efficacy (PFMESES) in performing PFME as scheduled and despite barriersj N 1924
Mean (SD)22.4 (4.5)23.2 (4.0)
Missing6963
95% CI17.9 to 27.0e21.3 to 25.1f
a

The total UI score was calculated using the ICIQ-UI SF, and a higher score indicates a greater impairment from incontinence, with a possible total from 0 to 21.

b

95% CI around the mean was estimated using a t-distribution with 7 degrees of freedom.

c

95% CI around the mean was estimated using a t-distribution with 6 degrees of freedom.

d

Responses were not mutually exclusive.

e

UI prevalence was determined by the question ‘How often do you leak urine?’ and defined as ‘no’ if the answer was ‘never’ and ‘yes’ if it was any other response.

f

95% CI around the proportion who responded ‘yes’ was estimated using a t-distribution with 7 degrees of freedom.

g

95% CI around the proportion who responded ‘yes’ was estimated using a t-distribution with 6 degrees of freedom.

h

The total score of women’s confidence in their practice of PFME was calculated using the self-efficacy (PFMESES) questionnaire. Higher scores indicate greater confidence of women’s practice of PFME (score can range from 17 to 85).

i

The subscore of belief in PFME execution and its benefits was calculated using 11 of the 17 questions of the self-efficacy (PFMESES) questionnaire. Higher scores indicate a greater belief in PFME execution and its benefits (score can range from 11 to 55).

j

The subscore sum of belief in performing PFME as scheduled and despite barriers was calculated using 6 of the 17 questions of the self-efficacy (PFMESES) questionnaire. Higher scores indicate greater belief in performing PFME as scheduled and despite barriers (score can range from 6 to 30).

Note

All 95% CIs are estimated using cluster-level analyses, weighted by the cluster size, after natural log transformations of the data.

TABLE 15

Prevalence of FI at 10–12 weeks using RFIS

Intervention (n = 88)Control (n = 87)
Prevalence of FI at 10–12 weeks using the RFIS 41
Total RFI scorea N 8282
Mean (SD)1.2 (3.1)0.7 (2.2)
Missing65
Total score < 472 (87.8%)78 (95.1%)
4 ≤ Total score ≤ 64 (4.9%)2 (2.5%)
7 ≤ Total score ≤ 124 (4.9%)1 (1.2%)
Total score ≥ 132 (2.4%)1 (1.2%)
95% CI0.2 to 2.0b0.2 to 0.9c
Prevalence of FIdYes15 (18.1%)11 (13.3%)
No68 (81.9)72 (86.7%)
Missing54
95% CI6.6% to 28.9%e4.8% to 21.2%f
Prevalence of flatus incontinence
Prevalence of flatus incontinencegYes34 (41.0%)30 (35.7%)
No49 (59.0%)54 (64.3%)
Missing53
95% CI17.9% to 64.6%e25.5% to 45.8%f
a

Total RFI score was calculated using the RFIS, and a higher score indicates greater impairment from incontinence, with a possible total score from 0 to 20.

b

95% CI around the mean was estimated using a t-distribution with 7 degrees of freedom.

c

95% CI around the mean was estimated using a t-distribution with 6 degrees of freedom.

d

Prevalence of FI was determined by the following two questions: ‘Do you leak, have accidents or lose control with solid stool?’ and ‘Do you leak, have accidents or lose control with liquid stool?’ and was defined as ‘no’ if the answer to the above question was ‘never’ and ‘yes’ if it was any of the other options.

e

95% CI around the proportion who responded ‘yes’ was estimated using a t-distribution with 7 degrees of freedom.

f

95% CI around the proportion who responded ‘yes’ was estimated using a t-distribution with 6 degrees of freedom.

g

Prevalence of flatus incontinence was determined by the question: ‘Do you leak, have accidents or lose control with gas (flatus or wind)?’and defined as ‘no’ if the answer to the above question was ‘never’ and ‘yes’ if it was not.

Note

All 95% CIs are estimated using cluster-level analyses, weighted by the cluster size, after natural log transformations of the data.

Copyright © 2024 MacArthur et al.

This work was produced by MacArthur et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This is an Open Access publication distributed under the terms of the Creative Commons Attribution CC BY 4.0 licence, which permits unrestricted use, distribution, reproduction and adaptation in any medium and for any purpose provided that it is properly attributed. See: https://creativecommons.org/licenses/by/4.0/. For attribution the title, original author(s), the publication source – NIHR Journals Library, and the DOI of the publication must be cited.

Bookshelf ID: NBK609157

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