Stress Urinary Incontinence
Conditions
Keywords
stress urinary incontinence, non-ablative Er:YAG laser
Brief summary
Study is designed to assess the long-term clinical effects and safety profile of non-ablative Er:YAG (IncontiLase®) laser treatment, the durability of the results and the optimal treatment regimen for mild-to-severe stages of genuine female stress urinary incontinence (SUI).
Detailed description
All patients with urodynamically proven SUI, who have failed/declined conservative therapies will be informed about the study. They will be invited to attend a screening/baseline visit. At this visit, they will be asked to perform a standardised 1 hour pad test. Their medical history will be checked and they will undergo a clinical and vaginal examination, pregnancy test and dip stick urinalysis. If their 1 hour pad weight is \>2g and they meet all other inclusion / exclusion criteria, they will be eligible for inclusion. They will receive detailed instructions for performing a 24 hour pad test, and will be asked to keep a 3 day voiding diary. They will be given the International Consultation on Incontinence Questionnaire Short Form (ICIQ-UI SF). Patients will then undergo 3 outpatient treatment visits. The timing of visits will be approximately 1 month apart. At each of their 3 outpatient appointments, they will be asked about any deleterious effects since their last appointment. Patients will receive 3 treatments in total. Patients will be invited to attend a follow-up visits 3, 6, 12 and 18 months after the 3rd treatment and asked to complete the 1 hour pad test, 24 hour pad test, 3 day voiding diary and ICIQ-SF questionnaire. At the 18-, 24- and 30-month follow up, they will be given an option to receive additional single session of non-ablative Er:YAG laser treatment. At each visit, and during additional visit after 36 months, they will be asked to complete all of the tests (1 hour pad test, 24 h hour pad test, 3 day voiding diary and ICIQ-UI SF).
Interventions
DEVICENon-ablative thermal-only Er:YAG laser therapy
Each patient will receive 3 sessions of Er:YAG laser treatment for SUI (IncontiLase®). Single-session treatments will be offered to patients after 18, 24 and 30 months following the initial three sessions.
Sponsors
Fotona d.o.o.
Adrian Gaspar
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult Female, 18 years of age or older * Clinical and urodynamic study (UDS) diagnosis of Stress Urinary Incontinence * No significant improvement in urinary incontinence from at least one previous conservative treatment, such as pelvic floor muscle training
Exclusion criteria
* Pre-existing bladder pathology including prior radiation treatment * Pregnancy * BMI\>35 * Radical pelvic surgery or previous incontinence surgery * Urinary tract infection or other active infections of urinary tract or bladder * SUI III (VLPP \> 60 cm H2O) * Any form of pelvic organ prolapse (POP) stage 2 or greater, according to POP-Q * Diagnosis of urge incontinence * Diagnosis of collagen disorders eg.benign joint hypermobility / Elhers-Danlos / Marfans etc. * Incomplete bladder emptying * Vesicovaginal fistula * Faecal incontinence * Unwillingness or inability to complete follow-up schedule * Unwillingness or inability to give Informed Consent * Failure to comply with diary requirements during extended baseline period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of ICIQ-UI SF scores | Baseline, 3, 6, 12, 18, 24, 30 and 36 months | Change in mean test scores range = 0 - 21; low score = mild symptoms, high score = significant impact on quality of life. |
| Assessment of 1 hour pad weight test | Baseline, 3, 6, 12, 18, 24, 30 and 36 months | The change in standardised 1 hour pad weight test from baseline to 36 months following treatment schedule. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in 24 hour pad weight test | Baseline, 3, 6, 12, 18, 24, 30 and 36 months | The change in standardised 24 hour pad weight test from baseline to 36 months following treatment schedule. |
| Change in leakage frequency as assessed by 3 day voiding diary | Baseline, 3, 6, 12, 18, 24, 30 and 36 months | The change in leakage frequency from baseline to 36 months following treatment schedule. |
Outcome results
None listed