Participants underwent transvaginal surgery for pelvic organ prolapse, including the assigned apical suspension procedure. The SSLF procedure, performed unilaterally, was a modification of the Michigan 4-wall technique.
19 (link),20 The ULS procedure, performed bilaterally, was a modification of the technique described by Shull.
21 (link) Both apical suspension procedures used two permanent and two delayed absorbable sutures (four sutures total).
17 (link) All patients with uterine prolapse underwent vaginal hysterectomy. A concomitant retropubic mid-urethral sling (Tension-Free Vaginal Tape [TVT®]; Ethicon Women’s Health and Urology, Somerville, NJ) was performed for stress urinary incontinence. Other concomitant surgeries were performed at the surgeon’s discretion; biologic or synthetic graft materials were not allowed for the prolapse repairs.
Usual perioperative care included routine perioperative teaching and standardized postoperative instructions. Participants randomized to perioperative BPMT received an individualized program that included one visit 2–4 weeks prior to surgery, and four post-operative visits (2, 4–6, 8, and 12 weeks after surgery).
17 (link) (
eTable 2) Pelvic floor muscle training, individualized progressive pelvic floor muscle exercise, and education on behavioral strategies to reduce urinary and colorectal symptoms were performed at each visit. Self-reported adherence to BPMT was assessed at 6, 12, and 24 months. All BPMT interventionists attended centralized in-person training prior to the initiation of the study.
Data collection occurred at baseline, during surgery and hospitalization, and at regular intervals up to 24 months postoperatively with Pelvic Organ Prolapse Quantification (POPQ)
18 (link) evaluations and symptom assessments occurring at 6, 12 and 24 months. BPMT interventionists were masked to surgical randomization. All outcome assessors were masked to both perioperative BPMT and surgical intervention assignment, including research personnel who conducted vaginal examinations and trained telephone interviewers who administered patient reported outcomes from a centralized facility. Participants were masked to the surgical group assignment, and study surgeons were masked to perioperative BPMT group assignment.