| Literature DB >> 35980443 |
Kari Bø1,2, Sònia Anglès-Acedo3, Achla Batra4, Ingeborg Hoff Brækken5,6, Yi Ling Chan7, Cristine Homsi Jorge8, Jennifer Kruger9, Manisha Yadav10, Chantale Dumoulin11.
Abstract
INTRODUCTION AND HYPOTHESIS: This manuscript from Chapter 3 of the International Urogynecology Consultation (IUC) on Pelvic Organ Prolapse (POP) describes the current evidence and suggests future directions for research on the effect of pelvic floor muscle training (PFMT) in prevention and treatment of POP.Entities:
Keywords: Long-term; Pelvic floor muscle training; Pelvic organ prolapse; Physical therapy; Postpartum; Surgery
Mesh:
Year: 2022 PMID: 35980443 PMCID: PMC9477909 DOI: 10.1007/s00192-022-05324-0
Source DB: PubMed Journal: Int Urogynecol J ISSN: 0937-3462 Impact factor: 1.932
PEDro quality scores of RCTs
| E: Eligibility criteria specified | |
| 1. Subjects randomly allocated to groups | |
| 2. Allocation concealed | |
| 3. Groups similar at baseline | |
| 4. Subjects blinded | |
| 5. Therapist administering treatment blinded | |
| 6. Assessors blinded | |
| 7. Measures of key outcomes obtained from > 85% of subjects | |
| 8. Data analysed by intention to treat | |
| 9. Statistical comparison between groups conducted | |
| 10. Point measures and measures of variability provided |
+: criterion is clearly satisfied, -: criterion is not satisfied, ?: not clear if the criterion was satisfied. Total number is determined by counting the number of criteria that are satisfied, except “eligibility criteria specified” score is not used to generate the total score. Total scores are out of 10
Outcome measure used in randomized controlled trials (RCTs) of pelvic floor muscle training to prevent or treat pelvic organ prolapse. Classification according to primary/secondary measures
| Primary outcome: | |
| • Stage of POP | |
| 1. POPQ (Braekken 2010b, Panman 2017, Wiegersma 2014, Hagen 2014, Barber 2014, Weidner 2017, Jelovsek 2018, Nyhus 2020, Due 2016a, Due 2016b, Hagen 2009, Stüpp 2011, McClurg 2014, Kashyap 2013, Pauls 2013, Pauls 2014, Panman 2016) | |
| • Positions of organs (imaging, observation) | |
| 1. Position of bladder and rectum by 3D-transperineal ultrasound (Braekken 2010b, Braekken 2010a, Nyhus 2020) | |
| 2. Anatomic failure/surgical failure (combined outcome: POPQ and no re-treatment) (Barber 2014, Wiedner 2017, Jelovsek 2018) | |
| • Symptoms of POP (not bladder symptoms) | |
| 1. Specific questions yes/no | |
| 2. POP-SS (Hagen 2017, Hagen 2014, Hagen 2009, McClurg 2014, Kashyap 2013) | |
| 3. Validated POP-specific questionnaire to describe frequency and bother of prolapse (Braekken 2010b, Braekken 2015) | |
| 4. PFDI-20/ | |
| 5. Number of days with prolapse symptoms in the previous 4 weeks (Hagen 2014) | |
| 6. VAS 0-100 POP symptoms (Nyhus 2020, Kashyap 2013) | |
| 7. Rating of women’s perception of health benefit (better, same, worse). (Hagen 2017, Hagen 2014, Hagen 2009)/symptoms same/better/worse (Wiegersma 2014, Cheung 2016) | |
| 8. PGI-I (Panman 2016, Panman 2017, Weidner 2017, Jelovsek 2018, Duarte 2020, Due 2016a) | |
| 9. VAS 0-10 improvement/deterioration (Wiegersma 2014) | |
| 10. Bulge/lump, pelvic heaviness, backache of P-QoL (Stüpp 2011) | |
| 11. Obstructive symptoms of POP as detailed of UDI-19 (Frawley 2010) | |
| • Muscle morphology by transperineal ultrasound (TPUS) | |
| 1. Levator ani muscle trauma (Nyhus 2020) | |
| 2. Cross-sectional area levator ani muscle by 2D transperineal ultrasound and 3D TPUS (Braekken 2010a) | |
| 3. Levator ani muscle length at rest and during max Valsalva by 3D TPUS (Braekken 2010a) | |
| 4. Pubovisceral muscle thickness at rest by 3D-TPUS (Braekken 2010a) | |
| • Quality of life | |
| • POP-qual (Brandt and Janse Van Vuuren, 2020) | |
| • Cost analyses and need of POP-treatment | |
| 1. The use of absorbent pads (Panman 2016, Panman 2017) | |
| 2. EuroQoL 5D-3L/SF-6-→ QUALY/ICER/ ICUR (Panman 2016, Panman 2017, Hagen 2017) | |
| 3. Use of health services in primary and secondary care (Hagen 2014) | |
| 4. Uptake of treatment for prolapse symptoms during the follow-up [Hagen 2017, Hagen 2014, Barber 2014, Jelovsek 2018 (combined outcome: POPQ and no re-treatment), Due 2016a, Due 2016b, Panman 2016, Panman 2017] | |
| Secondary outcomes: | |
| • Sexual symptoms/ dysfunction | |
| 1. ICIQ-VS (Hagen 2017, Hagen 2014, Hagen 2009) | |
| 2. PISQ12 (Hagen 2017, Panman 2016, Panman 2017, Wiegersma 2014, Hagen 2014, Weidner 2017, Duarte 2020, Due 2016a, Due 2016b, McClurg 2014, Pauls 2013, Pauls 2014) | |
| 3. Validated POP-specific questionnaire to describe frequency and bother of sexual symptoms (Braekken 2015) | |
| 4. Frequency of sexual intercourse, satisfaction with the frequency of intercourse, and the extent of their sexual issues, reasons for not having sex (Braekken 2015) | |
| 5. Semi-structured interview (changes in sexual desire, orgasm frequency, intensity, ability to achieve orgasm); perception of dryness, burning or discomfort/pain; self-confidence regarding sex, and/or if there were any other changes they experienced (Braekken 2015) | |
| 6. FSFI (Pauls 2013, Pauls 2014) | |
| • Bladder/urinary symptoms (pad test, questionnaire) | |
| 1. Bladder diary (Pauls 2013, Pauls 2014, Frawley 2010) | |
| 2. Pad test (Frawley 2010) | |
| 3. ICIQ-IU-SF (Hagen 2017, Braekken 2010b, Hagen 2014, Hagen 2009, McClurg 2014) | |
| 4. UDI-6 (Panman 2017, Wiegersma 2014, Barber 2014, Panman 2016, Pauls 2014, Jelovsek 2018, Due 2016a, Due 2016b, Panman 2016, Duarte 2020, Cheung 2016) | |
| 5. UDI-19 (Frawley 2010) | |
| 6. Validated POP-specific questionnaire to describe frequency and bother of bladder (Braekken 2010b, Braekken 2015) | |
| 7. ISI (Barber 2014, Jelovsek 2018) | |
| 8. Bladder symptoms of P-QoL (Stüpp 2011) | |
| • Bowel symptoms | |
| 1. CRADI-8 (Panman 2017, Wiegersma 2014, Panman 2016, Pauls 2014, Barber 2014, Jelovsek 2018, Due 2016a, Due 2016b, Panman 2016, Duarte 2020, Cheung 2016) | |
| 2. ICQ-BS (Hagen 2017, Hagen 2014, Hagen 2009, McClurg 2014) | |
| 3. Modified Wexner score (Frawley 2010) | |
| 4. Constipation scoring system (Frawley 2010) | |
| 5. Validated POP-specific questionnaire to describe frequency and bother of bowel (Braekken 2010b, Braekken 2015) | |
| 6. Bowel symptoms of P-QoL (Stüpp 2011) | |
| • QoL | |
| 1. P-QoL (Stüpp 2011) | |
| 2. SF-12 (Hagen 2017, Hagen 2014, Hagen 2009, McClurg 2014, Pauls 2014) | |
| 3. SF-36 (Weidner 2017) | |
| 4. PFIQ | |
| 5. MOS-SF12/ | |
| 6. Quality of life: interference/bother of prolapse symptoms with everyday life, scored 0 [not at all] to 10 [a great deal]): VAS (Hagen 2014, Hagen 2009, Cheung 2016) | |
| 7. World Health Organization Quality of Life (WHOQOL)-BREF (Pauls 2013, Pauls 2014) | |
| 8. IIQ-7 (Frawley 2010) | |
| 9. Assessment of Quality of Life (AQoL) score (Frawley 2010) | |
| • Changes of lifestyle | |
| 1. Lifestyle changes (Hagen 2017, Hagen 2014) | |
| • Body image | |
| 1. Normalized body image questionnaires (Weidner 2017) | |
| • Need of treatment for dyspareunia, urinary symptoms | |
| 1. Uptake of treatment for urinary symptoms during the follow-up (Barber 2014, Jelovsek 2018) | |
| 2. Uptake of treatment for dyspareunia during the follow-up (Weidner 2017) | |
| 3. Desired treatment before any intervention/end treatment: patient’s preference (Cheung 2016) | |
| Independent variables/outcomes: | |
| • PFM function/impairment | |
| 1. By manometry (Braekken 2010b, Braekken 2015, Duarte 2020, Nyhus 2020, Frawley 2010) | |
| 2. By surface electromyography during the rest and during the maximum voluntary contraction (Resende 2012, Nyhus 2020, Stüpp 2011, Pauls 2013, Pauls 2014) | |
| 3. By digital palpation of: | |
| • Maximum voluntary contraction/modified Oxford scale and muscular endurance/PERFECT (Resende 2012, Nyhus 2020, Hagen 2009, Stüpp 2011, McClurg 2014, Pauls 2013, Pauls 2014, Frawley 2010) | |
| • Normal/underactive/overactive/inactive (Panman 2017, Wiegersma 2014, Panman 2016) | |
| • Strength Brink grading system (Barber 2014, Weidner 2017) | |
| 4. By transperineal ultrasound (TPUS) | |
| • Change in levator ani muscle length at rest and during max Valsalva by 3D TPUS (Braekken 2010a) | |
| • Change in levator hiatal dimensions from rest to maximum PFM contraction by 3D transperineal ultrasound (Braekken 2010a, Nyhus 2020) | |
| • Training diary | |
| 1. Appointments attendence and self-reported daily diary (Hagen 2017; Braekken 2010b, Braekken 2010a, Braekken 2015; Hagen 2014; Barber 2014, Weidner 2017, Jelovsek 2018; Duarte 2020; Nyhus 2020; Hagen 2009; Stüpp 2011; McClurg 2014; Kashyap 2013; Frawley 2010) | |
| • Complications regarding PFMT treatment including bother of PFMT | |
| 1. Complications/adverse events (Cheung 2016, Braekken 2010b, Braekken 2010a, Braekken 2015, Hagen 2014, Panman 2017, Wiegersma 2014, Hagen 2017, Panman 2016, Weidner 2017, McClurg 2014, Jelovsek 2018) | |
| 2. Bother of PFMT by numeric rating scale 0–10 (due 2016a, due 2016b) |
Short- and long-term effect of pelvic floor muscle training (PFMT) compared with no treatment or lifestyle advice on pelvic organ prolapse in the general female population (POP)
| Design/n | Prolapse | Training program | Drop-out/adherence | Outcome | Results | PEDro score (0–10) | |
|---|---|---|---|---|---|---|---|
Piya-Anant et al. -03 [ Thailand | Unblinded RCT/654 women > 60 years | Anterior vaginal wall POP | PFMT (n = 330), vaginal palpation: 2 years of 30 contractions per day + eat more fruit and vegetables and drink 2 l of water per day. Ability to contract assessed by vaginal palpation. Follow-up every 6th months Control (n = 324): no intervention, same follow-up | Drop-out: 28% Adherence: No report of PFMT adherence or change in fruit/vegetable intake | Primary outcome: No, mild or severe prolapse assessed by Valsalva on vaginal examination | PFMT: 27% worsening; Control: 72% worsening; p = 0.005. Effect only seen in women with severe prolapse No long-term follow-up | 4 |
Ghroubi et al.-08 [ Tunisia | RCT/ 47 women, mean age 53.4 (SD 11) No information about blinding | Stages I and II anterior vaginal wall POP | 12 weeks, all had vaginal palpation PFMT (n = 27): 2 times per week for 5 weeks with individual PFMT + advice on healthy living by PT; home training 20 contractions per day for 7 weeks Control (n = 20): no treatment | Drop-out: 0 Adherence: not reported | Primary outcome: symptom of heaviness Secondary outcome; “Measurement of Urinary handicap scale” MUH; urodynamic tests; Ditrovie Quality of Life scale; patient satisfaction (VAS) | Heaviness after treatment: PFMT: 18.5%; Control: 70%, p < 0.001 Significantly better report on “MUH” in PFMT Uroflowmetry showed significant improvement in maximum flow rate | 6 |
Hagen et al.-09 [ UK | Assessor blinded RCT/47 women, mean age 56 years (SD 9) | Symptomatic stages I and II POP (all types) | 16 weeks 1: PFMT 5 visits with PT. Information of anatomy and PFMT + “the Knack” home exercise: 6 sets of max 10 contractions per day, use of diary + lifestyle advice sheet 2: Lifestyle advice sheet only | Drop-out: at 20 weeks: 13%, at 26 weeks: 15%. POP-Q data missing for 27/47 short term Adherence: 91% attended at least 3 PT sessions, 65% attended 5 visits. 61% rated as good/moderate compliers | Primary outcome: POP-Q; prolapse symptoms Secondary outcome: QoL/interference of daily living; self-report of change in POP; sexual function by ICIQ-VS, urinary and bowel symptoms by ICIQ-UI and ICIQ-BS Independent variable: Modified Oxford grading for PFM strength only in exercise group | PFMT significantly more likely to have improved POP stage (45% vs 0%, p = 0.04), significantly greater decrease in POP symptoms (3.5 vs 0.1, p = 0.021), significantly more likely to say their POP was better (63% vs 24%) Oxford grading (n = 15): significant improvement in exercise group: mean 0.5 (95% CI: 02–0.8). No effect on sexual function or urinary or bowel symptoms No long-term follow-up reported further than 26 weeks as above by questionnaire data | 6 |
Brækken et al.-10 [ Brækken et al.-10 [ Norway | Assessor blinded RCT/109 women, mean age 48.8 years (SD 11.8) | POP-Q stages I, II and III with and without symptoms. All types of POP | 6 months, all had vaginal palpation and assessment of PFM strength and endurance PFMT: information on not to strain on toilet + ‘the Knack;’ 3 sets of 8–12 contractions per day, diary; weekly visits with PT for 3 months, every second week for 3 months Control: information on not to strain on toilet; ‘the Knack’ | Drop-out: One drop-out in each group (1.8% of each) Adherence: 79% adhered to ≥ 80% of exercise sessions 86% attended all PT sessions and 89% adherence to home training program 10% control group reported that they had performed more PFMT than they did before baseline | Primary outcome: POP-Q; ultrasound of bladder and rectal position at rest; symptoms and bother (Mouritsen and Larsen-03) Secondary outcome ICIQ UI-SF; sexual dysfunction and bowel symptoms (Mouritsen and Larsen-03). Semi-structured interview on sexual function Independent variable: muscle strength by manometry | POP-Q stage: 11 (19%) in the PFMT vs 4 (8%) controls improved one stage (p = 0.04) Elevation of the bladder neck: ↑2.3 mm vs ↓0.6 mm; diff. 3.0 mm (95% CI: 1.5–4.4), p < 0.001 Elevation of rectal ampulla: ↑4.4 mm vs ↓1.1 mm, diff. 5.5 mm (95% CI: 1.4–7.3), p = 0.02 Symptoms: Vaginal bulging/heaviness: ↓ frequency 32/43 vs 8/26, p < 0.01; ↓ bother 29/43 vs 11/26, p < 0.01 ICIQ UI-SF. Effect size 0.62 in favor of PFMT, diff. 2.40 (95% CI: 0.90–3.80), p = 0.002 < 0.01 Bowel symptoms: no effect on emptying or solid FI Flatus: frequency diff. 31.2% (95% CI: 0.7–55) p < 0.01; bother diff. 25.3% (95% CI: 1.5–49.1) p < 0.01. Loose FI: frequency diff. 68.6% (95% CI: 40.2–97.0), p < 0.01; bother diff. 64.3% (95% CI: 39.2–89.4), p < 0.01 PFM strength (p < 0.01): PFMT: ↑13.1 cmH2O (95% CI: 10.6–15.5); Control: ↑1.1 cmH2O (95% CI: 0.4–2.7). Effect size: 1.21 Endurance (p < 0.01): PFMT: ↑107 cmH2O s (95% CI: 77.0–136.4); Control: ↑8 cmH2O s (95% CI: − 7.4–24.1). Effect size: 0.96 No long-term follow-up | 8 |
Stüpp et al.-11 [ Brazil | Assessor blinded RCT/37 women, mean age 55 years (SD 8) | Stage II POP. 56.7% had anterior vaginal wall POP, 10.8% posterior and 32.4% combination | 14 weeks Group 1 (n = 21): PFMT 7 visits with PT. Use of quick pull of a vaginal cone and stretch reflex followed by active PFM contraction. Use of Knack during different tasks. Home exercise: 3 sets of 8–12 maximum voluntary contractions held for 6–10 s. PTs called patients every fortnight. Global stretching and lifestyle: weight loss, fluid intake, constipation, avoidance of heavy lifting Group 2 (n = 16): Control: taught how to perform PFM contractions with no protocol. Same lifestyle and global stretching as PFMT group | Drop-out: 0% Adherence: 100% in intervention and 76.2% in control. 91% adherence to home training program | Primary outcome: POP-Q Secondary outcome: Urinary and bowel symptoms by P-QoL Independent variable: Modified Oxford grading, PERFECT, sEMG | POP-Q stage: significantly greater improvement in training group (anterior vaginal wall: p < 0.001, posterior vaginal wall: p = 0.025) QoL: significant difference in favor of PFMT Symptoms: SUI significant difference in favor of PFMT (p = 0.002), straining to empty bladder (p = 0.031). No effect on vaginal bulge interfering with emptying bowel (p = 0.250) PFM variables: significant difference in favor of PFMT No long-term follow-up | 5 |
Frawley et al.-12 [ Australia ICS Abstract | Assessor-blinded multicenter RCT/168 women, mean age 55.9 years (SD 9.9) | Symptomatic POP-Q stage I, II, III. 80% had stage II POP, 73% had anterior POP | 16 weeks PFMT: 5 appointments with PT, home exercise (see Hagen, 2009) + lifestyle advice Control: lifestyle advice | Drop-out at 6 months: PFMT – 14.3%; Control – 10.7%. Drop-out at 12 months: PFMT – 5.6%; Control – 21.3%. Adherence: 82.1% attended 4 or 5 PT sessions | Primary: prolapse symptom severity (POP-SS) Secondary: POP-Q stage Independent variable: Modified Oxford grading by vaginal palpation, manometry strength and endurance | Significant difference in symptoms in favor of PFMT at 6 and 12 months in favor of PFMT No difference between groups in POP-Q stage Significant difference in POP-Q points Ap and Bp at 6 months and Ap and Bp relative to hymen in favor of PFMT Significant better PFM strength in PFMT group measured by palpation at 6 months, but not at 12 months. No difference in manometry Long-term follow-up: 8 months with no supervised training or incentives as above | 7 |
Kashyap et al.-13 [ India | Unblinded RCT/140 women, mean age 47 years (SD 12) | POP-Q stage I-III. 63.5% had POP-Q stage I | 24 weeks All had vaginal palpation Group A: one-to-one PFMT instruction + self-instruction manual. 6 follow–up visits at week 1, 3, 6, 12, 24. Home exercise one set of 10 contractions held for 10 s ×3 per day. Diary Group B: self-instruction manual + home training program. 3 follow-up visits at week 6, 18, 24 | Drop-out: Loss to follow-up week 6: A: 27.1%, B: 12.9% Week 18: A: 22.9%, B: 31.4%. Week 24: Group A: 7.1%; Group B: 21.4% Adherence: not reported | Primary outcome: POP-Q stage POP symptom scale, VAS, QoL (PFIQ-7) | Significant improvement in POP-Q stage I and II and bulging at week 6, 18 and 24 in favor of PFMT. Significant difference between groups in favor of PFMT in VAS at week 18 and 24 Complete relief of symptoms in 24.5% in the PFMT group compared to 0 in the group B No long-term follow-up | 6 |
Hagen et al.-14 [ UK, NZ, Australia | Assessor-blinded multicenter RCT/447 women, mean age 56.8 years (SD 11.5) | Symptomatic POP-Q stage I, II, III 72% had stage II | 16 weeks PFMT (n = 224): 5 appointments with PT + home exercise (see Hagen, 2009) and lifestyle advice Control: (n = 222): lifestyle advice | Drop-out at 6 months: PFMT: 16%; Control: 14% Adherence: 80% attended 4 or 5 PT sessions 40% responded to questionnaire at 18 months follow-up after cessation of training | Primary: POP symptom severity (POP-SS) Secondary: POP-Q, perceived change of POP, uptake of further treatment, cost-effectiveness, Sexual function: ICIQ-VS and PISQ-12 Urinary and bowel symptoms by ICIQ-UI and ICQ-BS | Significantly greater decrease in POP symptoms at 6 and 12 months in PFMT group (mean reduction in POP-SS from baseline 3.77 [SD 5.62] vs 2.09 [5.39]; adjusted difference 1.52, 95% CI 0.46–2.59; p = 0.0053) Symptom of bulging at 6 months: PFMT – 13.8% reduction in n; Control – 3.4% reduction in n Bulging at 12 months: PFMT – 20.5% reduction in n; Control – 17.0% reduction in n POP stage: PFMT – 20% improved; Control – 12% improved; p = 0.052 Uptake of further treatment: PFMT – 30%; Control – 55%; p < 0.001 No significant difference between groups in proportion with improved POP stage (27% vs 20%, p = 0.10) Significantly more likely to say their POP was better (62% vs 17% at 6 months, 57% vs 45 at 12 months) Uptake of further treatment: 24% PFMT, 50% Control (risk ratio 2.1, 1.5–2.9, p < 0.0001) Significantly better for aspects of bladder (UI: p = 0.01, ICIQ-UI: p < 0.001 and fecal urgency (p = 0.041 but not FI. Results diminished at 12 months Overall, the net cost of the intervention per woman was £170·24–£38·63 = £131·61 Adverse effect in 8 participants in the PFMT group unrelated to the intervention Long-term follow-up, see McClurg 2019 | 8 |
Wiegersma et al.-14 [ Panman et al.-17 [ The Netherlands | Assessor blinded RCT/287 women, mean age 64.2 (SD 6.6) | Symptomatic POP-Q stage I and II | 3 months Both groups had vaginal palpation. “Watchful waiting” or PFMT PFMT: Information of the pelvic floor. Individualized, not standardized following vaginal palpation, weekly visit to start with + home exercise | Drop-out: 26 in PFMT, 10 in watchful waiting; 87% completed follow-up Adherence: not reported | Primary outcome: POP-Q and overall symptoms Secondary outcome PFDI-20, PFIQ-7, PISQ-12 Independent variable: Vaginal palpation: normal, underactive, overactive, inactive | No difference in POP-Q. Significant improvement in PFDI-20 in PFMT vs control; 57% in PFMT vs 13% in control reported overall improvement in symptoms UDI-6 significant (0.007) but POPDI-6 (0.110) and CRAD-8 (0.165) not significant PFDI-urinary symptoms: sign difference in favor of PFMT: -6.0 (95% CI: -9.1 to -2.9), p < 0.001 No sign difference between groups in PISQ-12 or anorectal symptoms NB. Below the presumed level of clinical relevance (15 point) No effect of PFM variables Long-term follow-up:12 months follow-up of Wiegersma et al.-14 and 2 years Panman et a.-17 with no further incentives: PFMT greater pelvic floor symptom improvement, lower absorbent pad costs and was more effective in women experiencing higher symptom stress | 5 |
Alves et al.-15 [ Brazil | Assessor blinded RCT/46 postmenopausal women, mean age 65.9 years | Anterior and posterior POP on POP-Q, some women did not have POP | 6 weeks All had vaginal palpation. All women performed a fitness program based on global muscle stretching, endurance and functional exercises PFMT: in addition to general program: 12 group sessions, 30 min, twice a week (four series of ten fast contractions together with four series of ten sustained contractions, lasting for 8 s) Control: general exercise program | Drop-out: 34.8% Adherence: not reported | Primary outcome: sEMG, Modified Oxford grading by vaginal palpation Secondary outcome: POP-Q, ICIQ | PFM contractility increased after PFMT, evaluated by sEMG (p = 0.003) and vaginal palpation (p = 0.001) Decrease in urinary symptoms (p < 0.001 for ICIQ-OAB scores p = 0.036 for ICIQ UI-SF) and anterior pelvic organ prolapse (p = 0.03) No long-term follow-up | 6 |
Due et al.-16a) [ Denmark | Assessor blind RCT/109 women, mean age 60 years (range: 33-79) | Symptomatic POP-Q ≥ stage II | 3 months PFMT: one individual session with PT to learn PFM contraction, 6 group visits with PT, Knack + lifestyle + home exercise 3 sets of 10 contractions/day compared to Control: lifestyle: 6 group sessions | Drop-out: 18% at 3 months, 22% at 6 months Adherence: not reported 31/42 women completing the PFMT handed in their training dairies (74 %) 9 months after cessation of training: data available for 83/109, but not reported | Primary outcome: Global improvement scale, POP symptoms, POP-Q Secondary outcome: Sexual function by PISQ-12 Urinary and bowel symptoms by PFDI-20 | Significantly better results in global improvement scale and POP symptoms in PFMT. No difference in POP-Q stage No effect on sexual function, urinary or bowel symptoms Long-term follow-up: 9 months after cessation of training; no difference between groups, but 13/43 (30%) control and 21/40 (52%) of PFMT group had not sought further treatment (p = 0.05) | 7, 4 |
Ahadi et al.-17 [ Iran | Pilot assessor blind RCT/40 women, mean age not reported | Stage I (42%) and II (58%) POP | 12 weeks. Both groups did home PFMT for 12 weeks (10 repetitions of a 5-s squeeze followed by a 5-s release). In addition: 4 weeks of 1. PFMT and lifestyle advice in addition to biofeedback twice a week in clinics 2. Lifestyle advice sheet and PFMT without biofeedback at home only. | Drop-out: 2 = 5% Adherence: Not reported | Primary outcome: P-QOL questionnaire Secondary outcome: stage of POP by POP-Q Independent variable: manometry | P-QOL: Significant difference in favor of supervised PFMT No significant difference between groups in POP-Q No significant difference between groups in manometry assessment No complications No long-term follow-up | 7 |
Hagen et al.-17 [ UK, NZ | Assessor-blinded multicenter RCT 412 women, mean age 56.8 years (SD 11.5) | Women who had not sought help for POP Symptomatic POP-Q stage I, II, III 74.5% had stage II (all types) | 16 weeks Intervention group: PFMT 5 appointments with PT over 16 weeks + home exercise (see Hagen, 2009) and lifestyle advice and Pilates-based pelvic PFMT classes and a DVD for home use + appointments at 1 and 2 years Control group: lifestyle advice leaflet (by post) | Drop-out: 21% at 1 year and 16% at 2 years (no difference PFMT vs Control) Adherence PFMT group: 74% attended 3 or 4 PT sessions Exercises last month (at 2 years): 77% PFMT vs 53% control group (odds ratio 3·22, 95% CI 1·94–5·32; p < 0·0001) | Primary outcome: POP-SS Secondary outcome: Sexual function by ICIQ-VS and PISQ-12, urinary and bowel symptoms by ICIQ-UI and ICIQ-BS, respectively | The mean POP-SS score at 2 years was 3·2 (SD 3·4) in the intervention group versus 4·2 (SD 4·4) in the control group (adjusted mean difference −1·01, 95% CI −1·70 to −0·33; p = 0·004) At 2 years, ICIQ-UI was significantly greater in the control group than in the intervention group (MD -0.83, 95% CI, -1.44 to -0.22; p = 0.008). Proportion of patients who had any urine leakage or severe incontinence did not differ between groups Bowel symptoms did not differ significantly between groups at 2 years, but interference associated with bowel symptoms was less frequent in the intervention group (MD -0.51, 95% CI -0.96 to -0.06; p = 0.026) Sexual symptoms did not differ between groups at 2 years 3 adverse effects all in intervention group (not related to PFMT): fall, pain in tailbone, chest pain and shortness of breath | 6 |
McClurg et al. (ICS abstract-19) [ Scotland | Multicenter RCT 8-10-year follow-up study of PFMT for Scottish part only (Hagen et al.-14) | See Hagen et al. 2014. POP stage I-III. No further incentives during follow-up time | See Hagen et al. 2014. No further incentives for PFMT during follow-up at 8-10 years Outpatient and inpatient hospital data linkage for subsequent treatment related to PFD (POP, UI, FI) | Drop-out: 310 of originally 447 participants from 11 of originally 23 centers Linked data available for 293 participants from the Scottish part of the original study only Adherence: not reported | Primary outcome: Any treatment relating to POP, UI, FI received during follow-up period Secondary outcome: treatment specifically for related surgery, conservative treatment (pessary or neurostimulation) or time to first treatment | Lower proportion of intervention group (43.6%) received treatment than the control group (52.8%). Difference was statistically significant in a mixed effect model (aOR 0.61, 95% CI 0.37 to 0.99 95% p = 0.047) and on multiple imputation (aOR 0.60, 95% CI 0.36 to 0.98, p = 0.042) Median time to first treatment or censoring in the intervention group was 3008 days (IQR = 589-3396) vs control group:2242 days (IQR = 628.5-3279. Significant hazard ratio in favor of the PFMT group: 0.65 (95% CI: 0.46-0.94, p = 0.020) No significant difference between groups in use of pessary or neurostimulation or undergoing any type of related surgery | Not applicable |
Randomized controlled trials comparing pelvic floor muscle training (PFMT) and pessary for pelvic organ prolapse (POP)
| Design | Prolapse | Intervention | Drop-out/adherence | Outcome | Effect | PEDro score (0-10) | |
|---|---|---|---|---|---|---|---|
Manonai et al.-12 [ India | Assessor blinded RCT 91 women, mean age 44 years (SD 8.9) | POP stage I and II | 16 weeks: *Colpexin +PFMT *Colpexin sphere alone Vaginal assessment and Colpexin pull test every 4 week | Drop-out: 6; 6.6 % Adherence: 2 women in Colpexin + PFMT adhered to < 80% adhered to Colpexin use No further report of adherence to PFMT or Colpexin | PFM strength QoL POP stage | No change in POP-Q stage No difference between groups No long-term follow-up | 8 |
Cheung et al.-16 [ China | Assessor blinded RCT comparing PFMT alone with PFMT + pessary 276 women, mean age 62.6 years (SD 9.6) | Symptomatic POP stage I-III, all types. Mostly stage II (69% intervention vs 67% control) and anterior (64.7% intervention vs 66.4% control) on waiting list for surgery | 16 weeks Intervention: Ring pessary (3 fit attempts) + PFMT: Nurse led: one teaching session, 3 individual sessions 4-8-16 weeks + daily home exercise daily with at least 2 sets of 8–12 preset exercise Repetitions per day, with 8–10 exercises per session at least two times per week Control: PFMT alone | Drop-out: Pessary + PFMT: 9.8% PFMT: 11.3% Adherence (at least 2 times a day/3 times/week at 12 months: Pessary + PFMT: 53.3% PFMT: 43.1% No information of pessary use | Primary outcome: change of POP symptoms and quality of life by PFDI-20; POPDI; PFIQ Secondary outcomes: *bothersome of prolapse symptoms *desired treatment *any complications | Sign higher decrease in POPDI/PFIQ in pessary group: PFDI-20: -29.7 compared with -4.7, P < 0.01; PFIQ: -29.0 compared with 3.5, P < 0.01) No difference in complication rates between groups. 66% were successfully fitted with pessary, 60% at 12 months De novo SUI: 48% in Pessary +PFMT vs 22.4% in PFMT alone No long-term follow-up | 7 |
Panman et al.-16 [ The Netherlands | Unblinded RCT on 162 women, mean age: 65.6 years (SD 6.4) with - 2-year follow-up | Symptomatic POP stage II (74%) and III (26%) | Two years Pessary + PFMT, median of treatments was 7 (IQR 6-10); over a median timeframe of 15.9 weeks (IQR 12-29.5 wk) (FUP 3-12-24 months) Group 1 (N = 82): pessary (open ring or ring with support or Gellhorn/Shaatz) fitted by trained research physician during 2 weeks (maximum 3 attempts) + appointments every 3 months Group 2 (N = 80): PFMT initial informative sessions + Same exercise regime (later tailored- based examination) 3-5 times a week, 2 or 3 times each day (during face-to-face contact and at home) + lifestyle and toilet advices + “the knack” +/- myofeedback or electric stimulation if needed | Drop-out: Pessary 8 (9.8%), PFMT 9 (11.3%) Did not receive randomized treatment: pessary 35 (34 unsuccessful fit); PFMT 4 Discontinued treatment: pessary 12, PFMT 10 Adherence: not reported | Primary: POP symptoms (PFDI-20, POPDI-6, PGI-I), POP stage (POPQ), costs (EuroQoL 5D 3L, QUALY, ICUR) Bladder and bowel symptoms (UDI-6, CRAD-8); specific and generic QoL (PFIQ-7, MOS-SF12, PCS-12, MCS12), sexual symptoms (PISQ12), adverse events Independent variable: vaginal palpation: normal, underactive, overactive or inactive | No difference between groups in overall PFDI-20 POP symptom score sign in favor of pessary (mean difference -3.2 points [95% CI, -6.3 to -0.0; P = 0.05]) Cost over 2 years PFMT: 437 $ Pessary:309 $ Pessary fitting fails in considerable portion of women Pessary treatment associated with more side effects than PFMT | 6 |
AI, anal incontinence; A-QoL, Assessment of Quality of Life; C, Control; CG, control group; CRADI-8, Colorectal-Anal Distress Inventory-8; EMG, electromyography; EURO-QoL 5D-3L, EuroQol five dimensions-three-level Quality of Life Instrument; FSFI, female sexual function index; I, intervention; IG, intervention group; ICIQ-UI-SF, International Consultation on Incontinence Questionnaire-Urinary incontinence short form; ICIQ-VS, International Consultation on Incontinence Questionnaire Vaginal Symptoms; ICIQ-BS, International Consultation on Incontinence Questionnaire-Bowel symptoms; ICIQ-FLUTS, International Consultation on Incontinence Questionnaire-female lower urinary tract symptoms; IIQ-7, Incontinence Impact Questionnaire-7; ISI, Incontinence Severity Index Questionnaire; LAG, Lifestyle advice group; MCS-12, Mental Component Summary-12; MOS-SF12, Mental Health Component Summary-Short Form-12; NMES, neuromuscular electrostimulation; PCS-12, Physical Components Summary-12; PFMT, pelvic floor muscle training; PISQ-12, Pelvic Organ Prolapse Incontinence Sexual Questionnaire-12; PFDI-20, pelvic floor distress inventory questionnaire-20; PFIQ-7, Pelvic Floor Impact Questionnaire-7; PGI-I, Patient Global Impression of Improvment; POP, pelvic organ prolapse; POP-Q, Pelvic Organ Prolapse Quantification System; POPDI-6, Pelvic Organ Prolapse Distress Inventory-6; POP-SS, Pelvic Organ Prolapse Symptom Score; P-QoL, Prolapse Quality of Life Questionnaire; PT, physical therapist; QUALY, quality-adjusted life year; ICER, incremental cost-effectiveness ratio; RCT, randomized controlled trial; sEMG, surface EMG; SF, sexual function; SF-6, 6-Item Short Form Health Survey; SF-12, 12-Item Short Form Health Survey; SF-36, 36-Item Short Form Health Survey; SUI, stress urinary incontinence; TPUS, transperineal ultrasound; TTNS, transcutaneous tibial nerve stimulation; UDI-6, Urinary Distress Inventory 6; UDI-19, Urogenital Distress Inventory-19; UI, urinary incontinence; VAS, visual analog scale; WHOQoL, World Health Organization quality of life questionnaire
Evidence for pelvic floor muscle training (PFMT) in connection with pelvic organ prolapse (POP) surgery
| Design | POP | Exercise intervention | Drop-out/adherence | Outcome | Results | PEDro score (0-10) | |
|---|---|---|---|---|---|---|---|
Frawley et al.-10 [ Australia | Assessor blinded RCT 58 women, mean age 56.5 (SD 10.5) | Women of any age undergoing vaginal or laparoscopic-assisted vaginal surgery for either POP repair (primary or recurrent) and/or hysterectomy (94% POP surgery) | 10 months Intervention (N = 30): PFMT+ lifestyle advice + the “knack” during 8 sessions with PT. 1 preoperatively (set of 6–8” contractions, with a rest period in between each contraction, repeated 8–12 times, 3 times/day; variety of positions) and 7 postoperatively at 3d-7w-7w-8w-10w-12w and 9 months (reduction dosage/intensity immediate postoperative period and gradual increase to the preoperative intensity by 6 weeks postoperatively and maintenance of an intensive level of PFMT for 3–6 m, then reduction in frequency of exercise sets to 1–2 sets/day by 12 month) Control (N = 28): pre- and postoperatively advice by gyn and nurse+lifestyle advice +/- PFM exercise without PT supervision | Drop-out = 12.1% (3 in intervention, 4 in control) Did not receive allocated group: 6 intervention + 1 control Adherence: *89% to physiotherapy visits *67% reported home training: 22% at < 1/week, 23% training 1–6 days/week, 22% training daily | Primary: Prolapse symptoms (obstructive symptoms of POP as detailed in the UDI) Secondary: bladder symptoms (UDI-19), QoL (IIQ-7, AQoL), bowel symptoms (Wexner, Constipation Scoring System), 3-day bladder diary, 48-h pad test Independent variable: Modified Oxford grading by vaginal palpation and manometry | 12-month postoperative no difference in prevalence of the primary outcomes (ORs 1.2, 1.3). No significant differences between groups on change scores of UDI (mean: 44.1 [5.1]; 54.0 [5.4], P = 0.20) nor the IIQ (median: 0.0 [9,14]; 10.0 [5,19], P = 0.09) PFM strength significant in favor of intervention on (vaginal testing and manometry) No further follow-up | 6 |
Pauls et al.-13 [ Pauls et al.-14 [ Same study US | Assessor blinded RCT N = 57 women, mean age: 58 (SD 10.5) years | Symptomatic POP (all types) undergoing reconstructive POP surgery | 12 weeks Long term at 24 weeks = 3 months after end treatment) Intervention (n = 29): PFMT 2 weeks preoperatively and 2-4-6-8 and 12 weeks postoperatively, in conjunction with a physician assessment Control (n = 28): physician assessment alone at all postoperative intervals | Drop-out: 5 PFMT vs 3 Control Adherence: not reported | Primary: WHOQOL-BREF Secondary outcome: POP symptoms (PFDI 20), POP stage (POPQ), bladder and bowel symptoms (voiding diaries, PFDI20), QoL (PFIQ7, SF-12), sexual symptoms (FSFI, PISQ12) Independent variables: Modified Oxford grading by vaginal palpation, intravaginal sEMG | At 12 weeks (Pauls et al.-13) No statistically significant difference between groups in POP symptoms, QoL or sexual, urinary or bowel symptoms POP stage not shown PFM variables: no difference in Modified Oxford grading between groups, significant difference in sEMG at rest at 12 weeks in favor of PFMT Long- term follow-up at 6 months after surgery (Pauls-14): no difference between groups | 5, 5 |
Barber et al.-14 [ US | Assessor blinded multicenter, 2 × 2 factorial RCT (randomizations: 1: perioperative PFMT or usual care; 2: SSLF or ULS) N = 374 women,mean age: 57.5 years (SD 10.9) PFMT vs 56.9 years (SD 10.9) Control | Stage II (39%), III (57%) or IV (4%) symptomatic POP (all types) + SUI undergoing POP surgery. | 12 weeks PFMT (n = 186): 5 visits. First 2-4 weeks before surgery (45 contractions/day, initial contraction 1 – 3,” increasing 1-2” per week to a maximum of 7” and instructions for resuming exercises postoperatively). 4 visits after surgery (2, 4-6, 8, 12 weeks). Individualized progressive PFMT (maximum 45–60 contractions per day and maximum 10 s of each contraction) + educational behavioral strategies. Maintenance program of 15 contractions per day at the maximum contraction duration achieved Control group (n = 188): Usual care: routine perioperative teaching and standardized postoperative instructions | Drop-out: 6 months; 6 PFMT vs 8 Surgery alone 24 months: 34 (18.3%) PFMT vs 24 (12.8%) surgery alone p = 0.15. Adherence: 93.4% (6 months) and 81,4% (24 months) to home training program 4.3% of surgery group received supervised PFMT outside of the study (24 months) | Primary outcome surgery: POP stage (POP-Q), POP symptoms (POPDI-6, PFDI-20, PGI-I), anatomic failure as composite outcome of position of organs + retreatment (1)descent of the vaginal apex more than one-third into the vaginal canal or (2) anterior or posterior vaginal wall descent beyond the hymen or (3) retreatment for prolapse) PFMT: primary outcome at 6 months: UDI and at 2 years: POPDI and anatomic success Independent variables: Vaginal palpation by Brink grading Adverse events | PFMT was not associated with greater improvements in POP scores than control group [treatment difference −8.0 (95% CI −22.1, 6.1) at 24 months] PFMT was not associated with greater anatomic success (24 months) PFMT was not associated with greater improvements in urinary or bowel scores (6-12-24 months) than control group or in QoL scores No differences in PISQ-12 or body image scores between groups at any point Baseline PFM strength mean score: 8 (Brink range 3–12). At 24 months, mean Brink scores were 8.2 and 8.0 in PFMT and usual care groups respectively (p = 0.27) Long-term effect: as above for 2 years after surgery; no effect Severe adverse events: Surgery: 16.5% and 16.7 in each surgery group PFMT: no adverse events reported | 6 |
Weidner et al.-17 [ US | Same as Barber et al. 2014 | See Barber et al.-14 | See Barber et al.-14 | See Barber et al.-14 | Secondary outcome of Barber et al.-14: Primary outcome of present study: change in body image and in Pelvic Floor Impact Questionnaire (PFIQ) short-form subscale, 36-item Short-Form Health Survey (SF-36), Pelvic Organ Prolapse-Urinary Incontinence Sexual Questionnaire short form (PISQ-12), Patient Global Impression of Improvement (PGII) Independent variable: Vaginal palpation by Brink scores | No statistically significant differences between groups in PFIQ, SF-36, PGII, PISQ-12, body image scale measures or Brink score | 4 |
McClurg et al.- 14 [ UK | Multicentre feasibility pilot RCT 57 women, median age: 60 (range 35–80) years | Symptomatic POP Stage I (8%), II (63%), III (27%), (50% anterior POP) undergoing primary POP surgery | 12 weeks 1 pre- and 6 postoperative sessions PFMT (n = 28): Preoperative: information of PFM by PT+ “the knack” + daily PFMT consisting of 3 sets of 10 maximum contractions (up to 10-s hold)/day with 4 s rest between sets, following by a 1-min rest followed by 10 fast contractions + lifestyle advice Same sessions postoperative Control (n = 29): only lifestyle advice postoperative | Drop-out: 7% PFMT and 7% control after surgery, 18% (50% examination) intervention and 14% (72% examination) control 6 months; 50% (82% examination) intervention and 56% (83% examination) control 12 months. Numbers attending for assessment were TG = 14/28 (50%) and CG = 11/29 (28%); at 12 months, 5/28 (18%) and 5/29 (17%) attended Adherence: Intervention group attended 80% of treatment sessions. Home exercise: overall good adherence in those recording (but only 28% recorded) | Primary outcome: POP symptoms score (POP-SS) Secondary outcome: POP stage (POP-Q) Bladder (ICIQ-IU-SF) and bowel (ICIQ-BS) symptoms, sexual symptoms (PISQ-12), QoL (SF-12) Independent variables: Modified Oxford grading by vaginal palpation, adverse events | Significant difference in POP-SS between groups in favor of PFMT at 12 months [MD 3.94; 95 % CI 1.358–6.750; t = 3.248, p = 0.006) Significant difference in SF-12 in favor of PFMT at 12 months (MD −6.88333; 95% CI −11.344 to −2.431, t = −3.218, p = 0.004) No differences in ICIQ or PISQ-12 scores POP stage changes and PFM variables no interpretation due to missing data (only 10 women examined at 12 months) Long-term follow-up: 6 and 12 months after surgery; as above No adverse events reported | 7 |
| Jelovsek et al.-18 [ | 5-year follow-up of OPTIMAL trial, see Barber et al. 2014 and Weidner et al. 2017 | See Barber 2014 and Weidner et al.-2017 | See Barber et al. 2014 and Weidner et al. 2017 | 374 originally participated At 5 years: 244 completed the extended trial Adherence: no report of adherence at 5 years or during time elapsed from surgery | See Barber et al.-14Primary surgical outcome: POP-Q and symptoms of bother Primary PFMT outcomes: time to anatomic failure and Pelvic Organ Prolapse Distress Inventory scores (range: 0-300) | Long-term follow-up 5 years after surgery: no differences between surgery with PFMT and surgery without neither on primary or secondary outcomes. No change since 24-month follow-up Estimated surgical failure rate was 61.5% and 70.3% in the two surgical groups Estimated anatomic failure rate was 45.6% in the PFMT group and 47.2% in the usual care group (adjusted difference, −1.6% [95% CI, −21.2 to 17.9]) Improvements in Pelvic Organ Prolapse Distress Inventory scores were −59.4 in the BPMT group and −61.8 in the usual care group (adjusted mean difference, 2.4 [95% CI, −13.7 to 18.4]) | Not applicable |
Brandt & Janse Van Vuuren-20 [ South Africa | Double blind 3-arm RCT 81 women, 18-75 years | POP Stage I-III scheduled for reconstructive POP surgery | 3 months 4 sessions with PT in group 1 and 2 within 6 months 1. PFMT including vaginal palpation, ultrasound, observation and sEMG of contraction 8-10 contractions once 5 days a week in progressive positions 2. PFMT + abdominal training (TrA) 3. Usual care, taught to pre-contract the PFM, no clinical assessment | Drop-out: 8.6% 2 in PFMT 2 in abdominal training 3 in control Adherence: 60% PFM exercises at 3 months, 55% at 6 months. Non-sig difference between group 1 and 2 | Primary: The Prolapse Quality of Life questionnaire, two-dimensional ultrasound, PERFECT (palpation: power, endurance, repetitions, fast contractions, every contraction timed), sEMG, Sahrmann scale, and manometry Urinary frequency at 3 months, bulging at 6 months Discomfort at 6 months LA at 6 months Sahrmann 6 months Secondary: *adherence *lumbar and pelvic health | No effect on Prolapse Quality of Life or POP symptoms PFMT: Significant Improved power, number of fast contractions, amount of movement, endurance, and Sahrmann and manometry measures – compared with the control group. PFMT + Abdominal training: Significant improvement in number of PFM contractions, Sahrmann and manometry measures compared with the control condition Significant (p < 0.05) increase in bulging and discomfort Both groups showed significantly increased urinary frequency (p < 0.05) compared with control No adverse effects of either interventions No report of long-term effect above 6 months | 8 |
Duarte et al.-20 [ Brazil | Assessor blind RCT 96 women, age: 66.7% > 60 years, 28.1% 40-60 years, 5.2% 37-40 years | Symptomatic POP II (43%), III, IV (all types) undergoing POP surgery | 9 weeks Both groups had vaginal palpation and manometry PFMT (n = 48): 4 preoperative (within 2 weeks preoperatively) and 7 postoperative supervised sessions with PT Postoperative PFMT started at day 40 after surgery with 7 postoperative weekly sessions Each session: 4 sets of 10 repetitions of maximum voluntary contractions with a 7 s hold/7 s rest (supine, sitting, kneeling and standing) + 5 quick contractions Same protocol at home at least 3 times/week Control (n = 48): only surgery | Drop-out: 2 (4%) in PFMT, 0 in control Adherence: 93% Intervention > 75% of the supervised sessions. 76% home training on 75-100% of the days prescribed | Primary outcome: POP symptoms (PFDI-20, PGI-I), Secondary: bladder and bowel symptoms, QoL (PFIQ-7), sexual symptoms (PISQ-12), perception of improvement Independent variables: PFM strength and endurance by manometry | No substantial difference in POP symptoms between the intervention and control at day 40 (adjusted mean difference -6, 95% CI -25 to 13) or day 90 (adjusted mean difference -4, 95% CI -23 to 14) The experimental group perceived marginally greater global improvement than the control group [mean difference -0.4 (95% CI -0.8 to -0.1) at day 90] PFMT was not associated with better improvements in urinary, bowel, sexual or QoL scores than control group No difference in PFM variables between groups No report of further long-term effect | 8 |
Nyhus et al.-20 [ Norway | Assessor blind RCT 159 women, mean age: PFMT+ surgery 60.1 (SD 11.2) vs surgery: 60.6 (SD 10.9) | Symptomatic POP II, III, IV (60% ≥ III) (all types) undergoing POP surgery | Mean 22 weeks waiting for surgery PFMT (n = 81): Preoperatively: vaginal palpation + written information leaflet and asked to daily PFMT consisting of 8–12 contractions, each held for 6–8 s, three times a day + lifestyle advice + “the knack” Two personal visits with PT at 2 and 6 weeks after inclusion preoperatively including vaginal palpation Optional weekly PFMT in groups with PT Control (n = 78): only surgery | 95% women completed the study intervention = 75, controls = 76) Drop-out: 6 in Intervention vs 2 in Control Adherence: 60 (80%) women in the PFMT group adhered to ≥ 70% to the intervention None of the participants met for the voluntary weekly group training sessions | Primary: POP symptoms (bulge sensation, VAS), POP stage (POP-Q), position of organs and muscle morphology (ultrasound 3D -TPUS) Secondary: anatomical POP Independent variables: Modified Oxford grading by vaginal palpation, 3D-TPUS, manometry, sEMG | No difference was found between surgery + PFMT and control with respect to PFM contraction assessed by Modified Oxford grading: 2.4 vs 2.2;P = 0.101), manometry (19.4 vs 19.7 cmH2O; P = 0.793), surface EMG (33.5 vs 33.1 mV; P = 0.815) and ultrasound (change in hiatal APD, 20.9% vs 19.3%; P = 0.211). Sensation of vaginal bulge: no difference between groups (VAS, 7.4 vs 6.0 mm; P = 0.598), POP distance from the hymen in the dominant prolapse compartment (−1.8 vs−2.0 cm; P = 0.556) and sonographic descent of the bladder (0.5 vs 0.8 cm; P = 0.058), cervix (−1.3 vs −1.1 cm; P = 0.569) and rectal ampulla (0.3 vs 0.4 cm; P = 0.434) No further long-term effect reported | 7 |
| Mathew et al.-21 [ | RCT/159 women >18 yrs Same study as Nyhus et al. 2020 | See Nyhus et al. 2020 | See Nyhus et al. 2020. | See Nyhus et al. 2020 | Primary outcomes: Symptoms of urinary and colorectal-anal distress assessed by validated PFDI sub-scales: UDI-6 and CRADI-8. Secondary outcome: patient reported quality of life related to urinary and colorectal-anal symptoms using the PFIQ sub-scales: UIQ and CRAIQ | No added effect of preoperative PFMT on symptoms or QoL related to urinary and colorectal-anal distress: no difference in mean postoperative symptom and QoL scores (95% CI) between the intervention and control group: UDI-6 16 (12–21) vs. 17 (13–22), CRADI-8 15 (11–18) vs. 13 (10–16), UIQ 11 (7–15) vs. 10 (6–13) and CRAIQ 5 (2–7) vs. 6 (4–9), all p > 0.05 |