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CompletedNCT03082118VESICALUpdated Jul 5, 2019

Vesair Continued Access Trial

An interventional study of Vesair Bladder Control System in Stress Urinary Incontinence, sponsored by Solace Therapeutics, Inc.. Completed at 7 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-05.

Sponsored by Solace Therapeutics, Inc. · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Jan 2019, 7 years 8 months ago, and no results have been posted to the registry.
Phase
Not applicable
Study type
Interventional
Enrollment
7
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study summary

Single arm study of the Vesair Balloon in postmenopausal women.

Read the detailed description

All women enrolled will be treated with the vesair balloon and followed for a maximum of 3 years, with balloon replacement annually.

02

Conditions studied

  • Stress Urinary Incontinence
03

In context

Urinary Incontinence

1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.

This study's enrollment of 7 is below the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.

Browse Urinary Incontinence studies →

Lead sponsor

Solace Therapeutics, Inc. is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Post-menopausal women with SUI or stress predominant mixed incontinence
  • Maximum score on IQOL of 60
  • Positive cough test for leakage
  • Willing to undergo procedures
  • Free from infection
  • Have previously tried (and failed) noninvasive treatment for SUI

Exclusion criteria

Exclusion Criteria:

  • SUI due to SUI
  • Urge-predominant mixed incontinence
  • Incontinence of neurogenic etiology
  • 2 or more UTIs in past year and 1 in past 3 months
  • Surgery for SUI in the past 6 months
  • taking medication that can be used to treat SUI
  • taking medication that affects urinary symptoms for less than 3 months
  • undergoing biofeedback
  • Grade 3 or worse cystocele
  • last menstrual period within 12 months
  • oral progesterone or estrogen in the past 12 months
  • BMI > 40
  • involuntary detrusor contractions or discomfort during bladder filling
  • previous stage III or worse cancer
  • previous cancer of the urinary tract
  • previous symptoms for early stage cancer in the past 2 years
  • anticoagulation therapy other than aspirin
  • history of prosthetic heart valve
  • neurological or connective tissue condition or disease affecting bladder function
  • known allergy to device components
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
7 participants (actual)

Study arms

  • Experimental
    Vesair Arm

    Subjects treated with the Vesair Bladder Control System at enrollment.

    Device: Vesair Bladder Control System

Interventions

  • DeviceVesair Bladder Control System

    Intravesical balloon

    Also known as: Vesair Balloon

06

What researchers measure

Primary outcomes

  1. Improvement on patient-reported outcomes

    Improvement reported on questionnaires

    Time frame: 3-12 months

Secondary outcomes

  1. Reduction in leakage events

    Reduction in leakage events reported on a voiding diary

    Time frame: 3-12 months

07

Study locations

7 sites
  • Kaiser Permanente Urology
    Los Angeles, California 90027, United States
  • Kaiser Permanente Urogynecology
    San Diego, California 92110, United States
  • Georgia Center for Women
    Atlanta, Georgia 30312, United States
  • Regional Urology
    Shreveport, Louisiana 71106, United States
  • Institute for Female Pelvic Medicine and Reconstructive Surgery
    Allentown, Pennsylvania 18103, United States
  • Riddle Hospital, Main Line Health
    Media, Pennsylvania 19063, United States
  • West Penn Hospital, Allegheny Health Network
    Pittsburgh, Pennsylvania 15224, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03082118
Lead sponsor
Solace Therapeutics, Inc.
Responsible party
Sponsor
First posted
Mar 17, 2017
Start date
Mar 9, 2017
Primary completion
Jan 15, 2019
Completion
Jan 15, 2019
Last update
Jul 5, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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