Apical Suspension Repair for Vault Prolapse In a Three-Arm Randomized Trial Design (NCT02676973) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Apical Suspension Repair for Vault Prolapse In a Three-Arm Randomized Trial Design
United States360 participantsStarted 2016-02-29
Plain-language summary
The study is a multi-center, randomized, surgical trial of women with symptomatic post-hysterectomy apical (cuff) prolapse desiring surgical treatment. This study will compare the three available surgical treatments performed in usual practice. The purpose of this study is to compare two commonly performed mesh apical repair (sacral colpopexy vs. Apical Transvaginal Mesh) and vaginal native tissue apical repairs with mesh reinforced repairs. The primary outcome is measured over time (up to 60 months) using a survival analysis approach. Participants will be followed for at least 36-months (3-years) post surgery and up to a maximum of 60-months (5-years) during the primary trial. Participants who complete the primary trial will be approached for consent for long-term follow-up as part of a study extension and will be followed up to a maximum of 120-months (10-years).
The investigators hypothesize that treatment failure will not differ between vaginally and abdominally placed mesh for vault vaginal prolapse, and mesh repairs (regardless of route of implantation) will be superior to native tissue apical suspension.
Who can participate
Age range21 Years
SexFEMALE
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Inclusion criteria
✓. Women age 21 or older
✓. Prior total hysterectomy (no cervix present)
✓. Prolapse beyond the hymen (defined as Ba, C, or Bp \> 0 cm)
✓. Vaginal cuff descent into at least the lower two thirds of the vagina (defined as point C\> -2/3 TVL)
✓. Bothersome bulge symptoms as indicated on question 3 of the PFDI-20 form relating to 'sensation of bulging' or 'something falling out'
✓. Desires surgical treatment for post-hysterectomy vaginal prolapse
✓. Available for up to 60 month follow-up
Exclusion criteria
✕. Previous synthetic material or biologic grafts (placed vaginally or abdominally) to augment POP repair including anterior, posterior and/or apical compartments
✕. Known previous formal SSLS performed for either uterovaginal or post-hysterectomy vaginal vault prolapse \*