Pragmatic Evaluation of Performance and Safety of the Anchorsure® Transvaginal Device for Surgical Treatment of Apical Prolapse in Women
Recruiting
Observational Study
Prolapse; Female
Prolapse Uterovaginal
Prolapse; Cervix
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 50 and older
- Sex
- Female
- Study type
- Observational
- Participants needed
- 120 (estimated)
- Sponsor
- Centre Hospitalier Universitaire de Nīmes · Other
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About This Trial
Pelvic Organ Prolapse affects 50% of parous women, and apical prolapse is one of the most common types of prolapse. Treatment for apical prolapse ranges from observation, non-surgical treatment or surgical repair. An anchoring device can reduce dissection and operative time and is meant to provide strong fixation whilst minimizing potential postoperative pain by avoiding neurovascular injuries. Th…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Women with pelvic organ prolapse with leading edge at or beyond the hymen as confirmed by the pelvic organ prolapse quantification system (POP-Q), i.e. Ba ≥ -1 cm for the anterior compartment, and/or Bp ≥ -1 cm for the posterior compartment, and/or C ≥ -1 cm for the apical com…
Contacts