The European Study of Altis® Single Incision Sling System for Female Stress Urinary Incontinence;A prospective, post-market, single arm, multicenter comparing baseline data to the 12 and 36 month data in 136 patients with stress urinary incontinence

The European Study of Altis® Single Incision Sling System for Female Stress Urinary Incontinence;A prospective, post-market, single arm, multicenter comparing baseline data to the 12 and 36 month data in 136 patients with stress urinary incontinence - EASY-Study

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON40466

Enrollment

Registered

2013-05-30

Start date

2014-01-06

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

Stress urine incontinence / urinary loss

Interventions

Surgical procedure involving a single incision in witch a mid urethral sling will be placed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1.Pre dominant stress urinary incontinence 2.The stress urinary incontinence is confirmed during physical examination, stresstest or urodynamic assessment

Exclusion criteria

Exclusion criteria: 1. Hisstory of anti incontinence surgery 2. A post voiding bladder volume more than 100ml 3. Co-morbidity 4. Desire for future pregnancy

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the proportion of subjects that meet the criteria of cure at 12 months. Healing is defined as negative cough stress test (HST) and NO to question 3 of the UDI-6 questionnaire: Do you often suffer from urine leakage related to coughing sneezing or laughing. It is a composite endpoint of objective and subjective outcome measures.	—

Secondary

Measure	Time frame
Secondary goals: 1. Cough Stress Test (HST): objective endpoint 2. Question 3 of the UDI-6 questionnaire: subjective endpoint 3. Primary endpoint at 6 weeks, 6 months, and 36 months 24maanden 4. Reduction of urine loss in 24 hours at 6 weeks and 12 months. 5. Postoperative improvement adhv PGI-I questionnaire and patient satisfaction at every visit 6. Qmax and PVR at 6 weeks and 12 months and the variation compared to Baseline 7. anesthesia type 8. operation time 9. duration of hospitalization 10. Postoperative pain score using VAS 0-10 11. Device and procedure related adverse events	—

Measure

Time frame

Secondary goals: 1. Cough Stress Test (HST): objective endpoint 2. Question 3 of the UDI-6 questionnaire: subjective endpoint 3. Primary endpoint at 6 weeks, 6 months, and 36 months 24maanden 4. Reduction of urine loss in 24 hours at 6 weeks and 12 months. 5. Postoperative improvement adhv PGI-I questionnaire and patient satisfaction at every visit 6. Qmax and PVR at 6 weeks and 12 months and the variation compared to Baseline 7. anesthesia type 8. operation time 9. duration of hospitalization 10. Postoperative pain score using VAS 0-10 11. Device and procedure related adverse events

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)