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Transvaginal Mesh vs. Laparoscopic Colposacropexy- Study

RecruitingNAAges 18 Years - 99 YearsFemaleHelsinki University Central Hospital
NCT04478747 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The main objective of the study is to compare subjective efficacy of trans vaginal mesh and laparoscopic colposakropexy (CSP) in women with an apical prolapse. The CSP group is further divided into two sub-groups; one where the mesh fixation is only at the apical part of the vagina, and another where the fixation is also extended to the levator plane. The secondary outcomes are safety (peri- and post-surgery complications, pain, erosion), objective efficacy (simplified POP-Q), and re-operation rate. Subjective outcome also includes the assessment of sexual satisfaction. Cost-effectiveness is studied by comparing both direct costs and QALYs.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age over 18 years and capability to understand the study protocol either in Finnish or Swedish. * Objectively diagnosed symptomatic apical prolapse (leading apical prolapse (points C/D) ≥ -2) and a history of previous POP operation including hysterectomy. * No need for any other concomitant operations except colporrhaphies and possible prophylactic salpingo-oophorectomy in CSP groups Exclusion Criteria: * A history of serious or prolonged pain after any operation or current or previous prolonged (over 6 months) pain of any reason. * BMI over 40 * Regular use of systemic corticosteroid medication. * Incapability to understand the study protocol.
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What it tests

  • TVM
  • Colposacropexy
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Where

1 site
Helsinki Naistenklinikka
Helsinki, Finland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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