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| Evaluation of satisfaction of pelvic floor muscle training isolated and associated with tibial nerve stimulation in women with mixed urinary incontinence: a randomized, single-blinded clinical trial |
| Oliveira MC, Oliveira M, Silva H, Gomes A, Nascimento G, Marini G, Micussi MT |
| European Journal of Obstetrics, Gynecology, and Reproductive Biology 2021 Oct;265:60-65 |
| clinical trial |
| 7/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
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OBJECTIVES: To compare the satisfaction degree and pelvic floor manometry after pelvic floor muscle training isolated and associated with tibial nerve stimulation in women with mixed urinary incontinence (MUI). STUDY DESIGN: A randomized, single-blinded clinical trial was conducted. 24 women diagnosed with MUI were equally divided into two groups: pelvic floor muscle training isolated and associated to transcutaneous tibial nerve stimulation (TTNS). The study occurred in four stages: (1) evaluation: general information, pelvic floor manometry, the International Consultation on Incontinence Questionnaire -- Urinary Incontinence -- Short Form (ICIQ-UI-SF) and International Consultation on Incontinence Questionnaire -- Overactive Bladder (OAB) application; (2) intervention: carried out over 2 months twice a week; (3) post-intervention evaluation: vaginal manometry, reapplication of the questionnaires and the Patient Global Impression (PGI) application at the end of the 2-month intervention; and, (4) follow-up: evaluation after 1 month of the end of the intervention. The primary outcome was the ICIQ-UI-SF and the secondary outcomes were ICIQ-OAB, vaginal manometry, and PGI. The repeated measures ANOVA was used to assess the time-to-group interaction by assigning a significance level of 5%. RESULTS: There was no interaction between time and group for ICIQ-UI-SF (p = 0.17) and manometry (p = 0.56). There was interaction for ICIQ-OAB (p < 0.01). PGI was reported as "much better" with 41.67% in the PFMTG+TTNS and 16.67% in the PFMTG after the intervention (p = 0.04). CONCLUSIONS: The results showed weak evidence that TTNS, in combination with PFMT, may be an intervention that can be used to treat MUI. The satisfaction degree was better with associated intervention.
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