Solace Stress Urinary inContinence Control Efficacy and Safety Study (SUCCESS)

Solace Therapeutics

Status: Completed

Conditions: Stress Urinary Incontinence

Treatments: Device: Solace Sham Treatment; Device: Solace Bladder Control (Vesair) Balloon

Study type: Interventional

Funder types: Industry

Identifiers

NCT02210273

CD1001

Details and patient eligibility

About

The SUCCESS 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: 221 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

• 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)
• Incontinence of neurogenic etiology
• Urge predominant Mixed Incontinence
• Bladder infection (including bladder inflammation or edema) or Urinary Tract Infection (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 recurrent (>1) or recent (within 5 years) kidney stone(s)
• 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: Double Blind

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221 participants in 2 patient groups

Treatment

Experimental group

Description:

Subjects undergoing treatment with the Solace Bladder Control (Vesair) Balloon on day 0

Treatment:

Device: Solace Bladder Control (Vesair) Balloon

Solace Sham Treatment

Sham Comparator group

Description:

Subjects undergoing sham treatment on day 0, and treatment with the Solace Bladder Control (Vesair) Balloon at 3 months

Treatment:

Device: Solace Bladder Control (Vesair) Balloon

Device: Solace Sham Treatment