Evaluation of the patients* satisfaction and safety of a non-degradable urethral bulking agent for female stress urinary incontinence

Evaluation of the patients* satisfaction and safety of a non-degradable urethral bulking agent for female stress urinary incontinence - Euro study

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON46734

Enrollment

Registered

2018-03-12

Start date

2019-01-29

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

stress urinary incontinentce urinary incontinence

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Women: - > 18 years - who underwent treatment with bulkinjection therapy Urolastic for stress urinary incontinence

Exclusion criteria

Exclusion criteria: Incapable of giving informed consent

Design outcomes

Primary

Measure	Time frame
Improvement of symptoms assessed by the patients global impression of improvement (PGI-I)	—

Secondary

Measure	Time frame
1. Patient satisfaction on results of the treatment by assessed by three validated questions 2. Number of procedure related adverse events: hematoma, urinary retention, urgency incontinence, pain, dyspareunia, urinary tract infection, infection at the injection site, exposure or erosion of the bulk material. 3. Re-intervention rate: number of re-injection and excision of PDMS and other surgical treatments for persistent or recurrent SUI after PDMS. 4. Objective cure assessed by cough stress test	—

Measure

Time frame

1. Patient satisfaction on results of the treatment by assessed by three validated questions 2. Number of procedure related adverse events: hematoma, urinary retention, urgency incontinence, pain, dyspareunia, urinary tract infection, infection at the injection site, exposure or erosion of the bulk material. 3. Re-intervention rate: number of re-injection and excision of PDMS and other surgical treatments for persistent or recurrent SUI after PDMS. 4. Objective cure assessed by cough stress test

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Countries

Netherlands

Outcome results