Developmental trial of a new continence device (Vysera valve) that allows bladder emptying by abdominal straining, designed for those with urinary incontinence

Proof-of-principle trial of the Vysera continence valve to confirm ability to achieve bladder emptying by abdominal straining

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN97824963

Enrollment

Registered

2019-10-14

Start date

2014-05-14

Completion date

Unknown

Last updated

2020-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary incontinence Urological and Genital Diseases Urinary incontinence

Interventions

This is a non-randomised, cohort study assessing patients with urinary incontinence to determine whether a strain-activated device can be opened by abdominal straining, enabling potential to manage ur

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Stage 1 (Placement and immediate removal of device): 1. 18 years or older attending the clinical site for cystoscopy 2. Recovering from surgery at least 3 months post-surgery 3. Willing and able to give informed consent Stage 2 (Placement and removal after trial of bladder filling and voiding): 1. Post-prostatectomy male patients 18 years or older, suffering from stress urinary incontinence 2. Undergoing treatment for urinary incontinence or related issues 3. At least 3 months post-surgery 4. Not confined to bed. 5. Adequate bladder / urine storage function 6. Willing and able to give informed consent

Exclusion criteria

Exclusion criteria: 1. Mentally unstable or cognitively impaired and who are unable to comprehend the informed consent process 2. Renal impairment and/or ureteric reflux 3. Insufficient physical strength to strain determined by urodynamic testing, which is needed to operate the Vysera Urology Catheter Valve for voiding 4. Macroscopic haematuria 5. Symptomatic urinary tract infection (defined as a feeling of malaise, the presence of pyrexia in conjunction with bacteriuria) 6. In the opinion of the investigator are unable to participate 7. Diagnosed detrusor overactivity

Design outcomes

Primary

Measure	Time frame
Efficacy of the device (Vysera valve): successfully placed into a catheter or intra-urethrally and be opened with sustained abdominal pressure to allow the patient to void voluntarily. Assessed at time of use.	—

Secondary

Measure	Time frame
Clinician and patient satisfaction with the Vysera valve placement, use and removal process, assessed by interview at the time of use and a follow-up phone call at one week: 1. To evaluate the delivery of the device. 2. To evaluate the retrieval of the device. 3. To evaluate patient tolerance of the device. 4. To evaluate whether urinary containment can be achieved. 5. To assess the level of residual remaining in the bladder post - voiding. 6. To assess the adverse event profile of the device	—

Measure

Time frame

Clinician and patient satisfaction with the Vysera valve placement, use and removal process, assessed by interview at the time of use and a follow-up phone call at one week: 1. To evaluate the delivery of the device. 2. To evaluate the retrieval of the device. 3. To evaluate patient tolerance of the device. 4. To evaluate whether urinary containment can be achieved. 5. To assess the level of residual remaining in the bladder post - voiding. 6. To assess the adverse event profile of the device

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Countries

United Kingdom

Contacts

Public ContactJennifer Martin

drjkmartin@gmail.com+44 (0)1179505050

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026