OBJECTIVE: To determine whether use of a new personalized risk calculator increases patient satisfaction with the decision whether or not to have a prophylactic midurethral sling (MUS) during pelvic organ prolapse (POP) surgery. METHODS: We performed a randomized controlled trial involving English-speaking women without symptoms of stress urinary incontinence (SUI) with ≥ stage 2 POP who planned to undergo POP surgery with 1 of 4 fellowship-trained urogynecologists at a single academic center. Women with a history of prior POP or incontinence surgery, or who were pregnant, or unable to complete study forms were excluded. Participants were randomly assigned to standard preoperative counseling or preoperative counseling with the use of a validated, online risk calculator for de novo SUI after POP surgery. The primary outcome was patient satisfaction with the decision for prophylactic MUS placement during POP surgery at 3 months postoperative assessed using the Satisfaction with Decision Scale for Pelvic Floor Disorders. RESULTS:Sixty-three women were approached for participation. Forty-two agreed to participate, 41 underwent randomization, and 33 had POP surgery and completed 3-month follow-up. Of these 33, 17 were randomized to the risk calculator and 16 to standard counseling. The mean age was 61.2 ± 9.1 years, and 41% (14/33) had a prophylactic MUS. At 3 months postoperative, there was no difference in Satisfaction with Decision Scale for Pelvic Floor Disorders scores between groups (4.67 ± 0.46 [intervention] vs 4.78 ± 0.34 [control]; P = 0.61). CONCLUSIONS: Use of the de novo SUI risk calculator did not increase patient satisfaction with the decision regarding MUS placement during POP surgery.
RCT Entities:
OBJECTIVE: To determine whether use of a new personalized risk calculator increases patient satisfaction with the decision whether or not to have a prophylactic midurethral sling (MUS) during pelvic organ prolapse (POP) surgery. METHODS: We performed a randomized controlled trial involving English-speaking women without symptoms of stress urinary incontinence (SUI) with ≥ stage 2 POP who planned to undergo POP surgery with 1 of 4 fellowship-trained urogynecologists at a single academic center. Women with a history of prior POP or incontinence surgery, or who were pregnant, or unable to complete study forms were excluded. Participants were randomly assigned to standard preoperative counseling or preoperative counseling with the use of a validated, online risk calculator for de novo SUI after POP surgery. The primary outcome was patient satisfaction with the decision for prophylactic MUS placement during POP surgery at 3 months postoperative assessed using the Satisfaction with Decision Scale for Pelvic Floor Disorders. RESULTS: Sixty-three women were approached for participation. Forty-two agreed to participate, 41 underwent randomization, and 33 had POP surgery and completed 3-month follow-up. Of these 33, 17 were randomized to the risk calculator and 16 to standard counseling. The mean age was 61.2 ± 9.1 years, and 41% (14/33) had a prophylactic MUS. At 3 months postoperative, there was no difference in Satisfaction with Decision Scale for Pelvic Floor Disorders scores between groups (4.67 ± 0.46 [intervention] vs 4.78 ± 0.34 [control]; P = 0.61). CONCLUSIONS: Use of the de novo SUI risk calculator did not increase patient satisfaction with the decision regarding MUS placement during POP surgery.
Authors: Jordi Sabadell; Sabina Salicrú; Anabel Montero-Armengol; Núria Rodriguez-Mias; Antonio Gil-Moreno; Jose L Poza Journal: Int Urogynecol J Date: 2018-11-15 Impact factor: 2.894