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. 2018 Aug 19;2018(8):CD013108. doi: 10.1002/14651858.CD013108

NCT01095692.

Trial name or title ATHENA
Methods RCT
Participants Women with occult UI
Interventions POP + SUI surgery vs POP surgery alone
Outcomes Primary:
To compare the postoperative prevalence of stress incontinence in patients with or without TOT implant during a pelvic organ prolapse surgery [Time Frame: 6 months]
Secondary:
  • To compare the severity of postoperative stress urinary incontinence between the 2 groups [Time Frame: 6 months]

  • To compare the prevalence of new‐onset overactive bladder postoperatively between the 2 groups [Time Frame: 6 months]

  • To compare the severity of new‐onset overactive bladder between the 2 groups [Time Frame: 6 months]

  • To compare the prevalence of postoperative dyspareunia at 6 months between the 2 groups [Time Frame: 6 months]

  • To compare the prevalence of postoperative urinary retention between the 2 groups [Time Frame: 6 months]

  • To compare the severity of postoperative dyspareunia at 6 months between the 2 groups [Time Frame: 6 months]

  • To compare the prevalence of dyschezia and constipation at 6 months between the 2 groups [Time Frame: 6 months]

  • To compare preoperative and postoperative urodynamic tests of patients when they are incontinent at 6 months [Time Frame: 6 months]

  • To compare the postoperative Patient Global Impression of Improvement and degree of satisfaction at 6 months between the 2 groups [Time Frame: 6 months]

Starting date July 2010
Contact information A Cortesse: ariane.cortesse@sls.aphp.fr, Assistance Publique, Hôpitaux de Paris.
Notes clinical trials.gov; NCT01095692