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Comparison of Efficacy and Side Effects Between the Obtryx and Solyx Band With 5-year Follow-up.

NCT03916471 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 166

Last updated 2023-09-28

No results posted yet for this study

Summary

Boston2018 post-market clinical study is a prospective, randomized, non-inferiority study to assess the efficacy and adverse events of the Solyx™ Single Incision Sling (SIS) System compared to the gold-standard Obtryx™ II Sling System, in patients with stress urinary incontinence (SUI) and long-term follow-up (5 years).

Conditions

  • Stress Urinary Incontinence

Interventions

DEVICE

Solyx™ SIS System

Single-incision sling system

DEVICE

Obtryx™ II System (Halo)

Transobturator Mid-urethral Sling System

Sponsors & Collaborators

  • Instituto de Investigacion Sanitaria La Fe

    lead OTHER

Principal Investigators

  • Marta Garcia · Instituto de Investigación y Politécnico La Fe

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-21
Primary Completion
2025-01-01
Completion
2025-01-01

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03916471 on ClinicalTrials.gov