Solace European Confirmatory Trial (SOLECT)

Solace Therapeutics

Status: Completed

Conditions: Stress Urinary Incontinence

Treatments: Device: Solace Bladder Control System; Device: Solace Sham Treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT01676662

CD 1004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Treatment on Day 0

Experimental group

Description:

Subjects who are treated with the Solace Bladder Control System upon entry into the trial.

Treatment:

Device: Solace Bladder Control System

Sham Treatment on Day 0

Sham Comparator group

Description:

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:

Device: Solace Bladder Control System

Device: Solace Sham Treatment