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).
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
43
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.
Assessment of ICIQ-UI SF scores
Change in mean test scores range = 0 - 21; low score = mild symptoms, high score = significant impact on quality of life.
Time frame: Baseline, 3, 6, 12, 18, 24, 30 and 36 months
Assessment of 1 hour pad weight test
The change in standardised 1 hour pad weight test from baseline to 36 months following treatment schedule.
Time frame: Baseline, 3, 6, 12, 18, 24, 30 and 36 months
Change in 24 hour pad weight test
The change in standardised 24 hour pad weight test from baseline to 36 months following treatment schedule.
Time frame: Baseline, 3, 6, 12, 18, 24, 30 and 36 months
Change in leakage frequency as assessed by 3 day voiding diary
The change in leakage frequency from baseline to 36 months following treatment schedule.
Time frame: Baseline, 3, 6, 12, 18, 24, 30 and 36 months
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