Clinical trial NCT01676662: Solace European Confirmatory Trial
Official title: An Evaluation of the Solace Bladder Control System in the Treatment of Female Subjects With Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Keywords: Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Lead sponsor: Solace Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2012-08-31
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: Improvement in quality of life as assessed by pad weight tests assessments and questionnaires
timeFrame: 3 Months
Secondary outcomes:
measure: Incidence of treatment-related adverse events
timeFrame: 3 Months
measure: Severity of treatment-related adverse events
timeFrame: 3 Months
Other outcomes:
measure: Incidence of all adverse events
timeFrame: 36 Months
measure: Improvement in quality of life in all patients assessed with pad weight tests and questionnaires
timeFrame: 36 Months
measure: Severity of all adverse events
timeFrame: 36 Months
Locations:
city: Antwerp
country: Belgium
facility: University of Antwerp Hospital (Universitair Ziekenhuis Antwerpen)
state: Edegem
city: Brussels
country: Belgium
facility: UZ Brussel
city: Gent
country: Belgium
facility: UZ Gent
city: Naples (Napoli)
country: Italy
facility: University of Naples (Università Degli Studi Di Napoli "Federico II" )
city: Rome
country: Italy
facility: Universita Campus Bio-medico di Roma
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
Study officials:
affiliation: University of Naples
name: Giovanni Tommaselli, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wyndaele JJ, De Wachter S, Tommaselli GA, Angioli R, de Wildt MJ, Everaert KC, Michielsen DP, Van Koeveringe GA. A randomized, controlled clinical trial of an intravesical pressure-attenuation balloon system for the treatment of stress urinary incontinence in females. Neurourol Urodyn. 2016 Feb;35(2):252-9. doi: 10.1002/nau.22708. Epub 2015 Jan 16.