Solace European Confirmatory Trial

Stress Urinary Incontinence Clinical Trial

— SOLECT  

Official title:

An Evaluation of the Solace Bladder Control System in the Treatment of Female Subjects With Stress Urinary Incontinence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01676662
• Other study ID #: CD 1004
• Status: Completed
• Phase: N/A
• First received: August 23, 2012
• Last updated: June 22, 2017
• Start date: September 2012
• Est. completion date: January 2017

Study information

• Verified date: June 2017
• Source: Solace Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 2017
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Device:
• Solace Bladder Control System
Subjects may undergo treatment every 12 months until study completion.
• Solace Sham Treatment
Sham procedure that resembles treatment with the Solace Bladder Control System

Locations

Country	Name	City	State
Belgium	University of Antwerp Hospital (Universitair Ziekenhuis Antwerpen)	Antwerp	Edegem
Belgium	UZ Brussel	Brussels
Belgium	UZ Gent	Gent
Italy	University of Naples (Università Degli Studi Di Napoli "Federico II" )	Naples (Napoli)
Italy	Universita Campus Bio-medico di Roma	Rome
Netherlands	Catharina Ziekenhuis	Eindhoven
Netherlands	Maastricht University Medical Center	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Solace Therapeutics, Inc.

Countries where clinical trial is conducted

Belgium,  Italy,  Netherlands, 

References & Publications (1)

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 incontinenc — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of all adverse events	Rate of incidence of all adverse events for all patients	36 Months
Other	Improvement in quality of life in all patients assessed with pad weight tests and questionnaires		36 Months
Other	Severity of all adverse events	Severity of all adverse events for all patients	36 Months
Primary	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.	3 Months
Secondary	Incidence of treatment-related adverse events	Site-reported adverse events designated as related to the treatment.	3 Months
Secondary	Severity of treatment-related adverse events	Site-reported adverse events designated as related to the treatment.	3 Months