Solace European Confirmatory Trial

Not Applicable

Completed

• Conditions: Stress Urinary Incontinence
• Interventions: Device: Solace Bladder Control System; Device: Solace Sham Treatment

• Registration Number: NCT01676662
• Lead Sponsor: Solace Therapeutics, Inc.

Brief 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.

Detailed Description

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 Timeline

• Study First Submitted: 2012-08-23
• Study First Submitted QC: 2012-08-28
• Study First Posted: 2012-08-31
• Study Start: 2012-09
• Primary Completion: 2014-06
• Study Completion: 2017-01
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-22
• Last Update Posted: 2017-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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)

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sham Treatment on Day 0	Solace Sham Treatment	Patients who undergo a sham procedure upon entry into the trial, with treatment with the Solace Bladder Control System at 3 months after the sham procedure.
Treatment on Day 0	Solace Bladder Control System	Subjects who are treated with the Solace Bladder Control System upon entry into the trial.
Sham Treatment on Day 0	Solace Bladder Control System	Patients who undergo a sham procedure upon entry into the trial, with treatment with the Solace Bladder Control System at 3 months after the sham procedure.

Primary Outcome Measures

Name	Time	Method
Improvement in quality of life as assessed by pad weight tests assessments and questionnaires	3 Months	Comparison of increases in pad weight test and patient reported outcomes on questionnaires.

Secondary Outcome Measures

Name	Time	Method
Incidence of treatment-related adverse events	3 Months	Site-reported adverse events designated as related to the treatment.
Severity of treatment-related adverse events	3 Months	Site-reported adverse events designated as related to the treatment.

Trial Locations

Locations (7)

University of Antwerp Hospital (Universitair Ziekenhuis Antwerpen); 🇧🇪 Antwerp, Edegem, Belgium

UZ Brussel; 🇧🇪 Brussels, Belgium

UZ Gent; 🇧🇪 Gent, Belgium

Universita Campus Bio-medico di Roma; 🇮🇹 Rome, Italy

University of Naples (Università Degli Studi Di Napoli "Federico II" ); 🇮🇹 Naples (Napoli), Italy

Catharina Ziekenhuis; 🇳🇱 Eindhoven, Netherlands

Maastricht University Medical Center; 🇳🇱 Maastricht, Netherlands