NCT03077490

Comparison of Single Versus Multicenter Outcomes for Pelvic Organ Prolapse Repair Using a Mesh-capturing Device

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 319 (actual)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: Female
• Age: 18 Years – 90 Years
• Healthy volunteers: —

Summary

Comparison of single versus multicenter outcomes for pelvic organ prolapse repair using a mesh-capturing device (The Uphold™ Vaginal Support System for apical and vaginal wall prolapse - Boston Scientific). 1-2 years follow up study comprison of 112 vs 207 patients.

Detailed description

112 women operated by two surgeons at one center (2 years follow up) are to be compared to 207 women operated by twenty six surgeons at twenty four centers (1 year follow-up). Screening at baseline for apical (uterine or vaginal vault) prolapse stage II with or without concomitant anterior or vaginal wall prolapse ≥ stage 2 according to the pelvic organ prolapse quantification (POP-Q) system. Surgical data including operation data, complications and hospital stay are to be compared. Anatomical outcome measurements by POP-Q evaluations. Subjective symptoms are to be evaluated by prolapse specific symptom questionnaires (PFIQ-7, UDI-6 and PFIQ) whereas sexual function to be estimated by PISQ-12.

Conditions

• Prolapse Genital

Interventions

Type	Name	Description
DEVICE	Transvaginal mesh Uphold TM Vaginal Support System
DEVICE	Transvaginal mesh Uphold TM Vaginal Support System.

Timeline

• Start date: 2015-03-04
• Primary completion: 2016-03-30
• Completion: 2017-02-01
• First posted: 2017-03-13
• Last updated: 2019-10-23

Regulatory

• FDA-regulated device study