Solace European Confirmatory Trial

Solace Therapeutics, Inc.80 enrolled

Overview

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.

Subject will undergo treatment with the Solace Bladder Control System or a sham procedure, with the results being compared at 3 months. All patients undergoing sham treatment are treated at 3 months.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Stress Urinary Incontinence

Interventions

Solace Bladder Control SystemDEVICE

Subjects may undergo treatment every 12 months until study completion.

Solace Sham TreatmentDEVICE

Sham procedure that resembles treatment with the Solace Bladder Control System

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Female 18 years of age or older with stress urinary incontinence (SUI) * Experienced SUI for at least 12 months and attempted and failed prior noninvasive treatment * Willing to undergo cystoscopic procedures required and 36 month follow-up * On stable medication for a minimum of 3 months * Free of local genital skin infection * Positive Pad Weight Test * Free of impassable urethral strictures, trauma or necrosis Exclusion Criteria (must answer NO): * Pregnant or planning to become pregnant during the study period * Non-ambulatory or bedridden or physically unable to complete test exercises * Morbidly obese (defined as BMI ≥ 40 kg/m2) * Bladder infection (including bladder inflammation or edema) or UTI within 3 months * History of recurrent urinary tract infections * Prior surgical procedure for incontinence within the past 6 months * Is taking medications for urinary incontinence other than anticholinergics * History of kidney stones * Has a prosthetic heart valve * Unable to tolerate any form of antibiotic * Taking anticoagulation therapy, other than aspirin * Has urinary incontinence due to Intrinsic Sphincter Deficiency (ISD)

Locations (7)

University of Antwerp Hospital (Universitair Ziekenhuis Antwerpen)

Antwerp, Edegem, Belgium

UZ Brussel

Brussels, Belgium

UZ Gent

Ghent, Belgium

University of Naples (Università Degli Studi Di Napoli "Federico II" )

Naples (Napoli), Italy

Outcomes

Primary Outcomes

Improvement in quality of life as assessed by pad weight tests assessments and questionnaires

Comparison of increases in pad weight test and patient reported outcomes on questionnaires.

Time frame: 3 Months

Secondary Outcomes

Incidence of treatment-related adverse events

Site-reported adverse events designated as related to the treatment.

Time frame: 3 Months

Severity of treatment-related adverse events

Site-reported adverse events designated as related to the treatment.

Time frame: 3 Months

Data from ClinicalTrials.gov

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