Clinical trial NCT04348994: Long-term Effectiveness of Non-ablative Er: YAG Laser for Treatment of Stress Urinary Incontinence (SUI)
Official title: 3-year Follow up of Patients With Stress Urinary Incontinence Treated With Minimally Invasive Er: YAG Laser
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Keywords: stress urinary incontinence
non-ablative Er:YAG laser
Lead sponsor: Espacio Gaspar Clinic
Sponsor class: OTHER
Collaborators: name: Fotona d.o.o.
First posted: 2020-04-16
Enrollment: 43
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of ICIQ-UI SF scores
timeFrame: Baseline, 3, 6, 12, 18, 24, 30 and 36 months
measure: Assessment of 1 hour pad weight test
timeFrame: Baseline, 3, 6, 12, 18, 24, 30 and 36 months
Secondary outcomes:
measure: Change in 24 hour pad weight test
timeFrame: Baseline, 3, 6, 12, 18, 24, 30 and 36 months
measure: Change in leakage frequency as assessed by 3 day voiding diary
timeFrame: Baseline, 3, 6, 12, 18, 24, 30 and 36 months
Other outcomes:
Locations:
Study officials:
References:
citation: Gaspar A, Koron N, Silva J, Brandi H. Vaginal erbium laser for treatment of stress urinary incontinence: optimization of treatment regimen for a sustained long-term effect. Lasers Med Sci. 2022 Jun;37(4):2157-2164. doi: 10.1007/s10103-021-03474-z. Epub 2022 Jan 24.