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@ARTICLE{Lange:1030928,
      author       = {Lange, Sören and Lange, Rainer and Tabibi, Elham and
                      Hitschold, Thomas and Müller, Veronika I. and Naumann,
                      Gert},
      title        = {{C}omparison of {V}aginal {P}essaries to {S}tandard {C}are
                      or {P}elvic {F}loor {M}uscle {T}raining for {T}reating
                      {P}ostpartum {U}rinary {I}ncontinence: a {P}ragmatic
                      {R}andomized {C}ontrolled {T}rial},
      journal      = {Geburtshilfe und Frauenheilkunde},
      volume       = {84},
      number       = {03},
      issn         = {0016-5751},
      address      = {New York, NY},
      publisher    = {Thieme},
      reportid     = {FZJ-2024-05520},
      pages        = {246 - 255},
      year         = {2024},
      abstract     = {Introduction: To compare three conservative treatment
                      options, standard care, pelvic floor muscle training (PFMT),
                      and vaginal pessaries, for postpartum urinary incontinence
                      (UI) that are accessible to most patients and practitioners
                      in a generalizable cohort.Materials and methods: A
                      multicenter, open-label, parallel group, pragmatic
                      randomized controlled clinical trial comparing standard
                      care, PFMT, and vaginal cube pessary for postpartum urinary
                      incontinence was conducted in six outpatient clinics. Sample
                      size was based on large treatment effects (Cramers' V >
                      0.35) with a power of $80\%$ and an alpha of 0.05 for a 3 ×
                      3 contingency table, 44 patients needed to be included in
                      the trial. Outcomes were analyzed according to the
                      intention-to-treat principle. Group comparisons were made
                      using analysis of variance (ANOVA), Kruskal-Wallis, and
                      chi-square test as appropriate. P < 0.05 was considered
                      statistically significant.Results: Of the 516 women
                      screened, 111 presented with postpartum UI. Of these, 52
                      were randomized to one of three treatment groups: standard
                      care (n = 17), pelvic floor muscle training (n = 17), or
                      vaginal cube pessary (n = 18). After 12 weeks of treatment,
                      treatment success, as measured by patient satisfaction, was
                      significantly higher in the vaginal pessary group $(77.8\%,$
                      n = 14/18), compared to the standard care group $(41.2\%,$ n
                      = 7/17), and the PFMT $(23.5\%,$ n = 4/17; χ 2 2,n = 52 =
                      14.55; p = 0.006, Cramer-V = 0.374). No adverse events were
                      reported. SUI and MUI accounted for $88.4\%$ of postpartum
                      UI.Conclusion: Vaginal pessaries were superior to standard
                      care or PFMT to satisfyingly reduce postpartum UI symptoms.
                      No complications were found.Keywords: pelvic floor muscle
                      training; postpartum; randomized controlled trial; standard
                      care; urinary incontinence; vaginal pessary.},
      cin          = {INM-7},
      cid          = {I:(DE-Juel1)INM-7-20090406},
      pnm          = {5251 - Multilevel Brain Organization and Variability
                      (POF4-525)},
      pid          = {G:(DE-HGF)POF4-5251},
      typ          = {PUB:(DE-HGF)16},
      doi          = {10.1055/a-2243-3784},
      url          = {https://juser.fz-juelich.de/record/1030928},
}