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Table 1 Item 13 in the SPIRIT checklist

From: Clinical and cost-effectiveness of vaginal pessary self-management compared to clinic-based care for pelvic organ prolapse: protocol for the TOPSY randomised controlled trial

  1. (a) All women will complete their 6-, 12- and 18-month follow-up questionnaires via a paper questionnaire booklet or via a link to complete online (participant preference). Only women in the clinic-based care group will attend a clinic appointment as per the centre’s standard care
  2. (b) Women in the clinic-based care group will have vaginal tissues assessed at each clinic appointment as per standard practice. Women in the self-management group will have their vaginal tissues assessed at baseline and 18-month appointments
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Trials

ISSN: 1745-6215