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Study about new device for urinary incontinece

SUPERA: Permanent, Removable and Self-Sustaining Urethral Probe for the Treatment of Incontinence and Urinary Retention - SUPERA: Permanent, Removable and Self-Sustaining Urethral Probe for the Treatment of Incontinence and Urinary Retention

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-4dvx2p
Enrollment
Unknown
Registered
2018-03-06
Start date
2015-03-01
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Female patients with neurogenic bladder.

Interventions

Group Experimental: 70 Women with urinary incontinence will be submitted to the use of the new device (SUPERA) for the treatment of urinary incontinence. Placement of a new device through the urethra
Device
E02.148.947.500

Sponsors

Universidade Federal de Pernambuco
Lead Sponsor
Hospital das Clínicas da Universidade Federal de Pernambuco - HC-UFPE
Collaborator

Eligibility

Sex/Gender
Female
Age
5 Years to 60 Years

Inclusion criteria

Inclusion criteria: Female patients with neurogenic bladder and participants in the clean intermittent catheterization program.

Exclusion criteria

Exclusion criteria: Patients with urethral deformities and active urinary tract infection.

Design outcomes

Primary

MeasureTime frame
Expected outcome: Change in the impact of quality of life of the patients during the six months of treatment use, verified through a quality of life questionnaire (Qualiveen). From a finding of value of P = 0.01 in the comparison of the intervention and control groups; and a value of P <0.01 in the analysis of the scores at the moments before and after the intervention.;Found outcome: A statistically significant difference was found between the quality of life questionnaire scores analyzed before and after the intervention. Varying between 40% between analyzes.—

Secondary

MeasureTime frame
Secondary outcomes are not expected.—

Countries

Brazil

Contacts

Public ContactFernanda Calisto

Universidade Federal de Pernambuco

fernandacamilacalisto@gmail.com+55-81-99546898

Outcome results

None listed

Source: REBEC (via WHO ICTRP)