Comparison of Two Apical Repair Methods in Women Undergoing Repairs for Prolapse

Randomized Trial of Sacrospinous Ligament Fixation Versus McCall Culdoplasty in Women Undergoing Vaginal Hysterectomy and Repairs for Prolapse

To date no study has determined prospectively which technique is superior to prevent recurrent Pelvic Organ Prolapse (POP) after vaginal hysterectomy- a major unmet clinical need. The aim of the study is to determine objective anatomical recurrent prolapse after Sacrospinous Ligament Fixation (SLF) vs McCall.

The aim of the study is to determine objective anatomical recurrent prolapse after SLF vs McCall. The study is designed as a Randomized Controlled Trial (RCT). Primary study endpoint will be at 12 months, secondary study endpoint at 24 months. The following parameters will be evaluated after one year: anatomical outcome, Quality of Life (QoL), sexual health, reoperations, and complications.

Inclusion Criteria:

• declined/ failed conservative treatment for POP
• planned vaginal hysterectomy with anterior/posterior colporrhaphy as indicated
• any symptomatic POP or stage II prolapse in any compartment
• at least stage I prolapse in the apical department
• women between 35 and 80 years of age
• good German language skills
• any concomitant prolapse surgery (anterior, posterior vaginal repair, suburethral tapes) as indicated
• concomitant salpingo-oophorectomy if indicated

Exclusion Criteria:

• Unwillingness to participate
• Neurological disorders
• Previous hysterectomy
• Desire to have children
• Connective tissue disorders (i.e. Ehlers-Danlos syndrome, Marfan syndrome)