To evaluate the mechanism of action of the Vesair Bladder Control System for future product development efforts to improve the System, for marketing efforts in the European Union and to provide data for publications.
ID
Source
Brief title
Condition
- Urinary tract signs and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Study endpoints:
Phase 1
1. Change in intravesical pressure(s) with the Vesair Balloon from baseline.
2. Change in leak point pressure(s) with the Vesair Balloon from baseline.
Phase 2
1. Patient Global Impression of Improvement of Incontinence (PGI-I)
2. Change in Incontinence Quality of Life (I QOL)
Secondary outcome
NA
Background summary
Solace Therapeutics, Inc. (the Sponsor) has developed the Vesair® Bladder
Control System, a proprietary system that treats the problems of stress urinary
incontinence at their source, within the bladder, immediately at the time of
the stress event. The Vesair Balloon attenuates transient pressure events
within the bladder caused by abdominal pressure changes such as, walking,
coughing, or laughing so that the adverse symptoms are reduced or eliminated.
The Vesair Bladder Control System was designed to allow for simple,
non-surgical insertion and removal of the Vesair Balloon into the female
bladder by the physician in his/her office.
Study objective
To evaluate the mechanism of action of the Vesair Bladder Control System for
future product development efforts to improve the System, for marketing efforts
in the European Union and to provide data for publications.
Study design
Single center study that will enroll 10 subjects. The study is conducted in
two phases.
Phase 1 is an acute urodynamics study comparing changes in intravesical
pressure during bladder fill in the adult female subjects with stress urinary
incontinence, at baseline and within one week after treatment with the Vesair
Bladder Control Balloon. Those subjects who choose to keep the balloon in
situ following the video urodynamic evaluation(s) enter Phase 2 of the study.
Phase 2 is for those subjects that choose to leave the balloon in place
following the urodynamic evaluations. They agree to follow up visits at 6
months, 12, 24, and 36 months.
Quality of Life questionnaires will be collected for all subjects at 6 months,
12 months and annually thereafter through 36 months.
The Solace Balloon will be exchanged at the 12 month visit for all subjects and
annually thereafter for an additional 24 month follow up period. Additional
balloon exchanges can be made as deemed necessary by the Study Investigator. At
the end of the study, subjects will be contacted within 30 days after the last
balloon has been removed to confirm final outcome.
Intervention
See study design.
Study burden and risks
Subjects participating in this study will require cystoscopic evaluation and
catheterization. The risks associated with these procedures include the
following: bladder and/or urethral trauma or irritation; pain; bladder or
sphincter muscle spasms; surrounding bruise or collection of blood; blood in
the urine; leakage of urine; and urinary tract infections (UTIs). In addition
to the events listed above, the anticipated risks associated with the use of
the Vesair® Balloon include insertion or removal trauma, urinary symptoms
(e.g., urgency, frequency, nocturia), urethral obstruction, stone formation in
the bladder, sediment on the Vesair Balloon, bladder mucosal abnormalities,
device malfunction or deflation, device being passed out of the bladder,
microscopic or gross hematuria, allergic reaction and bacteriuria. There may
be risks or side effects that are unknown at this time. The potential benefits
associated with the use of the Solace Balloon outweigh the potential risks.
Newbury Street 135
Framingham, MA 01701-4591
US
Newbury Street 135
Framingham, MA 01701-4591
US
Listed location countries
Age
Inclusion criteria
- Women
- Eighteen years of age or older with predominant SUI as evidenced by visual confirmation during stress maneuvers
- Experienced SUI for at least 12 months and attempted and failed prior noninvasive treatment (behavior modification, bladder training exercises, pelvic muscle rehabilitation, biofeedback, electrical stimulation or drug therapy) while incontinent.
- Willing to undergo cystoscopic and video urodynamics procedures required during the initial study period.
Exclusion criteria
- Pregnant or planning pregnancy during the next 12 months
- Morbid obesity, defined as BMI *40
- History of urosepsis, bladder infection (including bladder inflammation or edema), urethral inflammation, urethral edema, urinary tract infection or asymptomatic bacteriuria within the past 3 months
- Recurrent urinary tract infections (* 3 in the past 12 months)
- Prior surgical procedure for incontinence within the past 6 months (including suburethral sling placement and/or removal)
- Urinary incontinence of neurogenic etiology
- History of recurrent (>1) kidney stones, or one within the past 5 years
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL56920.068.16 |