MedTrace Logo

Solace European Confirmatory Trial

NCT01676662 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2017-06-23

No results posted yet for this study

Summary

The Solace European Confirmatory (SOLECT) Trial is designed to determine whether the Solace Bladder Control System is safe and effective for the treatment of Stress Urinary Incontinence (SUI) in adult females.

Conditions

  • Stress Urinary Incontinence

Interventions

DEVICE

Solace Bladder Control System

Subjects may undergo treatment every 12 months until study completion.

DEVICE

Solace Sham Treatment

Sham procedure that resembles treatment with the Solace Bladder Control System

Sponsors & Collaborators

  • Solace Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Giovanni Tommaselli, M.D. · University of Naples

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2014-06-30
Completion
2017-01-31

Countries

  • Belgium
  • Italy
  • Netherlands

Study Locations

More Related Trials

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 NCT01676662 on ClinicalTrials.gov