Author
Subjects
Design/intervention
Outcome
Results (IG vs CG)
Comment
Mason et al. (2010) [26]
N = 311
Nullipara
No previous SUI
Included between 11 and 14 weeks of pregnancy
2 arm RCT single blind
1. Control: usual care and instructions in PFMT.
2. Intervention: attending a physiotherapy class (45 min) with PFMT 1×/month for 4 months and to perform daily PFMT at home (8–12 close to maximum PFMC each held 6–8 s twice daily).
Individual assessment of correct VPFMC was performed in most women.
Bristol Female Lower Urinary Tract Symptoms Questionnaire (BFLUTS)
Leicester Impact Scale (LIS)
Self-reported number of leakage episodes last 3 days
36 weeks of pregnancy:
UI: 24/60 (40 %) vs. 51/96 (53 %) (p = 0.14)
3 months PP:
UI: 23/68 (33.8 %) vs. 33/80 (41.3 %) (p = 0.40)
No sig difference in symptoms and episodes of UI between groups in late pregnancy and PP
8 % were lost to follow-up. 23 % failed to return any of the questionnaires, and only 31 % completed all three sets of questionnaires
Only 65 % of IG women attended ≥1 exercise class
The trial was underpowered
Reilly et al. (2002) [25]
N = 268
Nullipara
Continent with increased bladder neck mobility
Included at 20 weeks of pregnancy
2 arm RCT
1. Control: routine antenatal care likely to include verbal instructions in PFMT.
2. Intervention: Individual PFMT with physiotherapist at monthly intervals from 20 week’ of pregnancy until delivery, with additional home exercises. 3 sets of 8 contractions (each held for 6 s), repeated twice daily. At 34 weeks of pregnancy the number of contractions per set was increased from 8 to 12. Women were instructed to contract the PFM when coughing or sneezing. Performing PFMT was recorded in a personal training diary.
Self-reported UI
Symptom questionnaire
Bladder neck mobility measured by ultrasound
3 months PP:
UI: 19 % vs. 33 % (p = 0.02)
QoL: higher score in the exercise group (p = 0.004)
Pad test: no difference
Bladder neck mobility: no difference
PFM strength: no difference
Lost to follow-up: 14 %
Adherence: 46 % IG women performed PFMT ≥28 days
51 % of CG did unsupervised PFMT
Agur et al. (2008) [33]
8 year
follow-up
N = 164
Self-reported UI
Performing PFMTSelf-reported UI
Performing PFMT
8 years after index delivery:
UI: 35 % vs. 39 % (p = 0.75)
Little or no difference in UI severity or QoL between groups.
Performing PFMT >1/weekly: 38 % in IG, CG not reported.
Drop-out: 34 % vs 23 %
(p = .004)
Table 17.2
Controlled trials assessing the effect of pelvic floor muscle training during pregnancy to prevent and treat incontinence including women with and without UI or AI at inclusion
Author | Subjects | Design/intervention | Outcome | Results (IG vs. CG) | Comments |
|---|---|---|---|---|---|
Stafne et al. (2012) [12] | N = 855 Nulli-/multiparae Continent/incontinent Included between 18 and 22 weeks of pregnancy | 2 arm RCT 1. Control: standard care (including written instructions in PFMT) 2. Intervention: attending weekly standard exercise program (60 min) and performing a home exercise twice weekly (45 min). The group and home exercise program consisted of aerobic activity and strength exercises including PFMT. Encouraged to perform 3 × 8–12 close to maximum PFMC each held for 6–8 s, 3 fast contractions added at the end of the contraction. Individual instruction on correct PFM, VPFMC checked Intervention period lasted 12 weeks | Self-reported UI and FI | After 12 weeks intervention (in pregnancy week 32–36): UI ≥1 times per week: 11 % vs. 19 % (p = 0.006) SUI ≥ 1 times per week: 7 % vs. 13 % (p = 0.03) FI: 3 % vs. 5 % (p = 0.24) | Loss to follow-up: 11 % Adherence: 55 % adhered to the exercise protocol (exercising ≥3 times per week at the end of the intervention period) |
Sangsawang et al. (2011) [32] | N = 70 Nulli-/multiparae SUI (≥1 episode of urinary leakage last month) Included between 20 and 30 weeks of pregnancy. | Quasi-experimental study, pre-post test with control group 1. Control: usual nursing care (including written instructions in PFMT) 2. Intervention: written and individual oral instruction in correct VPFMC (no vaginal palpation, but instructions in “stop-test” i.e. trying to stop or slow urinary flow) and PFMT. PFMT (45 min) in groups every second week for 6 weeks. Home exercises, with 40 repetitions daily, 5×/week (slow contractions with 10 s holding time and 10 fast contractions at the end of holding time). Performing PFMT was recorded in a training diary. | SUI severity (frequency and amount) SUI severity (VAS) | After 6 weeks intervention: No leakage: 39 % vs. 0 % (p = 0.001) Frequency SUI: 2 ± 4 vs. 15 ± 10 (p < 0.001) Severity SUI (VAS): 1.3 ± 1.3 vs. 6.8 ± 2.2 (p < 0.001) | Loss to follow up: 4 (IG) Adherence: 100 % in IG adhered to the exercise protocol (≥28 days of PFMT) Women in the IG were matched to CG women regarding age, parity and severity of SUI Women who failed to perform PFMC were categorized as dropout No assessment of correct VPFMC |
Bø and Haakstad (2011) [27] | N = 105 Nulliparae Continent/incontinent Sedentary Included within 24 week of pregnancy | 2 arm RCT 1. Control 2. Intervention: attending aerobic fitness classes including PFMT, 2–3×/week, and performing 10 daily PFMC at home. The PFMT instructed in classes consisted of three sets of close to maximum contractions of 8–12 repetitions with holding periods of 6–8 s performed in different positions. Women were encouraged to be physically active ≥30 min daily. Intervention period lasted 12–16 weeks. | UI and AI reported in a personal interview | 36–38 weeks of pregnancy: UI: 17/42 vs. 16/42 (p = 0.82) Flatus: 11/42 vs. 9/16 (p = 0.61) AI: 1/42 vs. 1/42 6–8 weeks postpartum: UI: 12/43 vs. 13/47 (p = 0.99) Flatus: 10/43 vs. 8/47 (p = 0.46) AI: 1/43 vs. 3/47 (p = 0.62) | Loss to follow-up: 20 % Adherence: 40 % of IG women attended at least 80 % of the exercise sessions No assessment of correct VPFMC Classes led by an aerobic instructor, verbal instructions were given No data on level of exercise and PFMT in the CG |
Ko et al. (2011) [28] | N = 300 Nulliparae Continent/incontinent Included between 16 and 24 week of pregnancy Performing PFMT was an exclusion criteria | 2 arm RCT 1. Control: received regular prenatal care. 2. Intervention: weekly PFMT in group led by a physiotherapist (45 min). And daily home exercises (3 repetitions of 8 contractions each held for 6 s) performed twice daily. Women were individually instructed in anatomy and correct VPFMC (by observation of inward movement of perineum during contraction). | UI reported in a personal interview Incontinence Impact Questionnaire (IIQ-7) Urogenital Distress Inventory (UDI-6) | 36 weeks of pregnancy: UI: 34 % vs. 51 % (p < 0.01) 3 days postpartum: UI: 30 % vs. 41 % (p = 0.07) 6 weeks postpartum: UI: 2 % vs. 35 % (p = 0.06) 6 months postpartum: UI: 16 % vs. 27 % (p = 0.04) The IG had lower scores in total UDI-6 and IIQ-7 than CG in late pregnancy and postpartum No differences in pregnancy outcome | Loss to follow-up: 0 Adherence (defined as performing ≥75 % of PFMT): 87 % |
Dinc et al. (2009) [17] | N = 92 Nulli-/multiparae Incontinent (having complaints of stress/mixed UI in their history) Included between 20 and 34 weeks of pregnancy | 2 arm RCT 1. Control 2. Intervention: thorough instructions in correct PFMC and a home exercise programme with gradually increasing repetitions and holding time until 3 sets of 15 repetitions with 10 s holding time and fast contractions added, repeated 3×/day. | Self-reported UI | 36–38 weeks of pregnancy: UI: 43 % vs. 71 % 6–8 weeks postpartum: UI: 17 % vs. 38 % Significant difference in episodes of UI, urgency, number of voids and amount of urine in pad test in favor of the IG both at 36–38 weeks pregnancy and at 6–8 weeks postpartum | Loss to follow-up: 12 Correct VPFMC checked at enrolment in both groups |
Woldringh et al. (2006) [31] | N = 264 Nulli-/multiparae Incontinent (≥2 episodes of loss of urine last month) Included between 17 and 20 weeks of pregnancy | 2 arm RCT 1. Control: routine care. 2. Intervention: four sessions of individual PFMT; three sessions (with 2 week interval) between 23 and 30 weeks of pregnancy and a fourth session 6 weeks PP. Written information including a detailed PFMT programme. | Self-reported severity of UI Incontinence Impact Questionnaire (IIQ) | No difference between IG and CG with respect to the severity of UI and impact of UI on daily life | Lost to follow-up: 50 % Adherence: 37 % reported to exercise almost every day No vaginal palpation of VPFMC, but observation and palpation of the perineal body |
Mørkved et al. (2003) [29] | N = 301 Nulliparae Continent/incontinent Included at 20 weeks of pregnancy | 2 arm RCT single blind 1. Control: customary information given by their midwife or general practitioner. Correct VPFMC checked at inclusion. 2. Intervention: 12 weeks of weekly PFMT in groups led by physiotherapist, with additional home exercises (10 close to maximum PFMC each held for 6 s, 3–4 fast contractions added on the last 4 exercises. Repeated 2×/day). Correct VPFMC checked at inclusion. Intervention period between 20 and 36 weeks of pregnancy | Self-reported UI (women reporting UI ≥1/week were categorized as incontinent) | 36 weeks of pregnancy: UI: 32 % vs. 48 % (p = 0.07) 3 months postpartum: UI: 20 % vs. 32 % (p = 0.02) | Dropout rate, 4 % Adherence: 81 % |
Sampselle et al. (1998) [30] | N = 72 Nulliparae Continent/incontinent Included at 20 weeks of pregnancy | 2 arm RCT single blind 1. Control: routine care. 2. Intervention: PFMT tailored to the woman’s individual ability, with muscle identification exercises preceding strength-building efforts. 30 PFMC daily at maximum or near-maximum intensity was recommended for strength building. Correct VPFMC were checked. | Self-reported UI (results reported as change in mean UI symptom score) | 35 weeks of pregnancy: Less UI symptoms were seen in the IG vs. CG (p = 0.04) 6 weeks postpartum: Less UI symptoms were seen in the IG vs. CG (p = 0.03) 6 months postpartum: Less UI symptoms were seen in the IG vs. CG (p = 0.04) | Adherence 85 % Study participants were financially compensated, $150 |
AI and PFMT in Pregnancy
No randomised or quasi-randomised trials reporting on the effect of PFMT on primary prevention of AI/FI in pregnancy were identified. Two trials including both continent and incontinent women reported on AI/FI in pregnancy. Bø and Haakstad (2012) [27] found no differences in AI symptoms between intervention and control groups. Although not reaching statistical significance, Stafne and co-workers (2012) [12] found fewer women with FI in the intervention group. In a subgroup analysis, however, performing PFMT in the second half of pregnancy was shown to have a protective effect on late pregnancy FI in multiparous and not in primiparous women [12]. These findings indicate that even among women with potential weakening or injury to the PFM or obstetric anal sphincter injury from a previous pregnancy or delivery, specific training of the PFM may prevent or reduce the severity of incontinence in subsequent pregnancies. However, as FI was not the primary outcome measure of these studies, both were underpowered to assess FI.
UI and PFMT Postpartum
In a systematic literature search on PubMed, ten randomised trials were found where six trials included a mixed population of continent and incontinent women [34–39] and four trials included incontinent women only [40–43] (Table 17.3). All four trials assessing the effect of PFMT in treatment of urinary incontinence postpartum had significant reductions in UI among intervention group women. Kim and co-workers (2012) [40] compared a PFMT programme with abdominal strengthening exercises and trunk stabilisation with or without supervision and found reductions in clinical symptoms of UI, including QoL measures in both groups. The improvements were greater in the supervised group, however, this was a pilot study and included only 20 postpartum women. In addition, two studies reported on 6 and 7 years follow up. Glazener and co-workers (2005) [44] found no differences between groups in UI after 6 years, whereas Dumoulin and co-workers (2013) [45] found that over 50 % of the women in the PFMT groups were still continent after 7 years.
Table 17.3
Controlled trials assessing the effect of pelvic floor muscle training postpartum to prevent and treat incontinence including women with and without UI or AI at inclusion
Author | Subjects | Design/intervention | Outcome | Results (IG vs CG) | Comment |
|---|---|---|---|---|---|
Urinary incontinence as primary outcome measure | |||||
Hilde et al. (2013) [34] | N = 175 Primiparae with no 3rd or 4th grade perineal tear Continent/incontinent Included at 6 weeks after vaginal delivery, stratified by major levator ani muscle defects | 2-arm RCT, single blind 1. Control: oral and written instruction on how to perform correct PFMC at inclusion, no further intervention 2. Intervention: weekly PMFT, in group led by physiotherapist. Daily home exercises: 3 sets of 8–12 close to maximum PFMC each held for 6–8 s, 3 fast contractions added on the last 4 exercises. Intervention period was 16 weeks. VPFMC checked at inclusion in both groups. Exercise diary of home exercises, group attendance recorded by physiotherapist. | Self-reported UI (ICI-Q UI SF) Pad test | Baseline: UI: 39 % vs 50 % 6 months postpartum: UI: 35 % vs 39 %, effect size: 0.89 (95 % CI: 0.6–1.3) Similar results in stratum with or without major leavtor ani defects, effect size: 0.89 (95 % CI: 0.5–.16) vs 0.90 (95 % CI: 0.5–1.5), respectively. No sign differenced in pad test between groups. | Loss to follow up: 8.6 %; Higher drop-out rate in IG: 12/87 vs. 3/88 96 % adhered to the exercise protocol (≥80 % of class sessions and daily home training Number of women performing PFMT at baseline: 35 % vs 50 % (p = .10) |
Kim et al. (2012) [40] | N = 20 Parous women Incontinent Included <6 weeks after normal vaginal delivery. | 2-arm RCT, pilot study 1. Control: Unsupervised PFMT 2. Intervention: Supervised PFMT Intervention period was 8 weeks. VPFMC checked at inclusion in both groups. Both groups were instructed to perform PFMT daily. All women received a booklet and exercise diary. | UI (Bristol female lower urinary tract symptoms) Vaginal squeeze pressure | Significant difference in UI and vaginal squeeze pressure in favour of the supervised PFMT group on after the intervention period. | Loss to follow up: 2/20 Adherence: not stated |
Ewings et al. (2005) [35] | N = 234 Parous women Continent/incontinent | Nested RCT 1. Control: usual postnatal care including verbal promotion of postnatal PFMT and leaflet explaining how to do PFMT. 2. Intervention: taught one to one with physiotherapist in hospital, with intervention to attend PFMT group at 2 and 4 months after delivery. No details of PFMT programme given. | UI | 6 months postpartum: UI: 60 % vs 47 % (p = .10) | Loss to follow-up: 19 % (27/90 vs 17/100) Adherence to PFMT in the intervention group: 5/90 (5.6 %) |
Dumoulin et al. (2004) [41] | N = 64 Parous women Weekly SUI at ≥3 months after their last delivery Recruited during annual gyenaecological visit | 3-arm RCT 1. Control: 8 weekly sessions of massage 2. PFM rehabilitation: Weekly sessions supervised by physiotherapist for 8 weeks: 15-minutes electrical stimulation (biphasic rectangular form; frequency 50 Hz; pulse with 250 ms; duty cycle, 6 s on and 18 s off for the first 4 weeks and 8 s on and 24 s off for the last 4 weeks; maximal tolerated current intensity) + 25 min PFMT with biofeedback + home training 5 days per week. 1. PFM rehabilitation (as group 2) + 30 min deep abdominal muscle training | Pad test Self-reported weekly UI | Less than 2 g urine on pad test after intervention period: CG: 0/19 PFM rehabilitation: 14/20 PFM rehabilitation + deep abdominal muscle training: 17/23 Significant difference in favour of the intervention groups (p = 0.001) Non-significant difference between the two intervention groups Incontinence Impact Questionnaire: Significant difference in favour of the intervention groups PFM strength: Non-significant difference between groups. | Drop-out rate: 6 % High adherence |
Dumoulin et al. (2013) [45] 7 year follow-up | N = 35 Combination of the previous two intervention groups | Pad test Self-reported UI | Less than 2 g urine on pad test (performed by 26 out of 35 women): 14/26 (53 %) Incontinence Impact Questionnaire: Significantly better than at baseline | 61.4 % of the participants from the original studies agreed to participate in the follow-up study Percentage performing any PFMT: 54 % | |
Chiarelli & Cockburn (2002) [36] | N = 720 Primi-/multiparae Continent/incontinent Postnatal women following forceps or ventouse delivery, or birthweight 4000 g or more Included while in hospital postpartum | 2-arm parallel group 1. Control: usual care, leaflet on PFMT 2. Intervention: continence promotion. One contact with physiotherapist on postnatal ward and another at 8 weeks postpartum (correct VPFMC checked at second visit). Intervention included individually tailored PFMT, use of transversus abdominus contraction, the ‘Knack’, techniques to minimise perineal descent, postpartum wound management. Written and verbal information. | Self-reported UI Urinary diary (3 days) | Baseline: UI: 18 % vs 17 % 3 months postpartum: UI: 31 % vs 38 % (p = .04) | Drop-out rate: 6 % in each group Adherence: 84 % vs 58 % (p = .001) |
Chiarelli et al. (2004) [47] 12 month follow-up | Self-reported UI
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