Efficacy of supervised pelvic floor muscle training with a home-based biofeedback device for urinary incontinence in postpartum women: protocol for a multicentre randomised controlled trial.

INTRODUCTION: Supervised pelvic floor muscle training (PFMT) of at least 3 months duration has been strongly recommended as a first-line treatment for women with stress urinary incontinence (SUI) or SUI-predominant mixed urinary incontinence (MUI), including elderly and postnatal women. However, for the treatment of SUI and MUI in postpartum women, it is currently uncertain whether supervised PFMT combined with a biofeedback device is superior to PFMT alone. Despite some supportive results, more reliable evidence is lacking. METHODS AND ANALYSIS: The study is designed as a multicentre assessor-blinded parallel-group randomised controlled trial comparing the efficacy of PFMT with a home-based pressure-mediated biofeedback device (intervention group) and that of at-home PFMT alone (control group) for women with new-onset SUI or SUI-predominant MUI after delivery. Five hundred eligible women from the obstetric outpatient clinics of five tertiary hospitals will be randomly allocated (1:1) and evaluated with repeated questionnaires, physical examinations and pelvic floor assessments at baseline (pretest), 3 months, 6 months and 12 months (postintervention) during the study period. Both groups will be instructed to follow the same training protocol under 3-month supervision after randomisation. The use of a biofeedback device with a self-assessment function will be added to the PFMT regime for patients in the intervention group. The primary outcome is the self-reported severity of urinary incontinence assessed through the short form of the International Consultation on Incontinence Questionnaire-Urinary Incontinence. Secondary outcomes include pelvic muscle support and strength, symptoms of pelvic organ prolapse, quality of life, sexual function, self-efficacy and adherence. ETHICS AND DISSEMINATION: Ethical approval has been received from the Peking Union Medical College Hospital ethics committee (JS-3192D). All results from the study will be submitted to international journals and international conferences. TRIAL REGISTRATION NUMBER: NCT05115864.

[Postpartum pelvic floor rehabilitation on prevention of female pelvic floor dysfunction: a multicenter prospective randomized controlled study].

OBJECTIVE: To study the postpartum pelvic floor rehabilitation on the improvement of pelvic floor electrical physiological indexes and the prevention of female pelvic floor dysfunction in China. METHODS: A multicenter prospective randomized controlled study was carried out. From October 2011, postpartum women in five provinces were randomly assigned into treatment group and control group. The women in treatment group received electrical stimulation and biofeedback treatment. The women in control group performed pelvic floor muscle exercise at home. When 6 months and 12 months after delivery, comparing two groups of patients with pelvic floor electrical physiological indexes and pelvic organ prolapse quantitation measurements (POP-Q), to evaluate the effect of postpartum pelvic floor rehabilitation on the prevention of pelvic floor dysfunction. Pelvic floor impact questionnaire short form (PFIQ-7) and pelvic organ prolapse/incontinence sexual questionnaire-12 (PISQ-12) were used to evaluate the influence on quality of life and sexual life. RESULTS: Until June 2013, 324 women were participated, 124 in control group, 200 in treatment group. According to the baseline results, there was statistical significance in the results of pelvic floor electrical physiological indexes between the treatment and control groups in postpartum 6 months and 12 months; the proportion above level III of type I and type II muscle fibers strength in the treatment group, it was from 41.5% (83/200) and 40.5% (81/200) to 76.3% (145/190) and 79.5% (151/190) in postpartum 6 weeks and postpartum 6 months, increased to 80.6% (58/72) and 80.6% (58/72) in postpartum 12 months, improved significantly comparing with the control group (P < 0.01). According to Point Aa, treatment group and control group in the postpartum 6 weeks was (-2.2 ± 0.7) versus (-2.4 ± 0.6) cm, in postpartum 12 months (- 2.5 ± 1.1) versus (- 2.7 ± 0.6) cm, the improvement in treatment group was statistically significant (P < 0.01). And the other points were not significantly different (P > 0.05). There was no significant difference in the questionnaires in quality of life and quality of sexual life (P > 0.05). CONCLUSION: Neuromuscular electrical stimulation and biofeedback therapy in the early postpartum period could obviously improve pelvic floor electrical physiological indexes, and is beneficial to prevent the pelvic floor dysfunction.

[Continuous improvement of portable domestic pelvic floor neuromuscular electrical stimulation on the pelvic floor function of patients with urinary incontinence].

OBJECTIVE: To evaluate continuous improvement of portable domestic pelvic floor neuromuscular electrical stimulation on the pelvic floor function of patients with stress urinary incontinence after short-term pelvic floor electrophysiological treatment in hospital. METHODS: Totally 60 women with stress urinary incontinence were recruited for this randomized controlled trial. The control group including a total of 30 patients, only received 4 weeks pelvic floor electrophysiological treatment in the hospital. Family consolidation treatment group (experimental group) including 30 patients, after 4-week treatment in hospital, received 12-week of pelvic floor neuromuscular electrical stimulation using portable electrical stimulator at home under the guidance of doctors. In post-treatment 6 months and 9 months, 1-hour pad test was measured for urine leakage, pelvic floor electrical physiological parameters were assessed, and subjective improvement of symptoms of urinary incontinence were evaluated. All these data were analysed to compare the effect of the two groups. RESULTS: In 9 months after treatment, average change of urine leakage, the control group and experiment group were (75±24)% versus (99±3)%, the difference was statistically significant (P<0.01). In the experiment group, strength of type I muscle (4.4±0.7), strength of type II muscle (4.8±0.4) and pelvic floor dynamic pressure [(96±12) cmH(2)O, 1 cmH(2)O=0.098 kPa] were better than those of control group [3.2±1.0, 4.3±0.9, (86±10) cmH(2)O, respectively], the differences were statistically significant (P<0.01). Subjective outcome, the control group and experiment group were (6.5±2.9) versus (1.8±1.7), subjective outcome between the two groups had significant difference (P<0.01). CONCLUSION: After short-term pelvic floor electrophysiological treatment in hospital, the portable domestic pelvic floor neuromuscular electrical stimulation in patients with stress urinary incontinence is helpful to continuous improvement of pelvic floor function.