Long-term Effectiveness of Non-ablative Er: YAG Laser for Treatment of Stress Urinary Incontinence (SUI)

3-year Follow up of Patients With Stress Urinary Incontinence Treated With Minimally Invasive Er: YAG Laser

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).

Study Overview

• Status: Completed
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Device: Non-ablative thermal-only Er:YAG laser therapy

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).

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Laser therapy; Non-ablative thermal-only Er:YAG laser treatment using IncontiLase® protocol.	Device: Non-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.; Other Names: IncontiLase®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline, 3, 6, 12, 18, 24, 30 and 36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 24 hour pad weight test	The change in standardised 24 hour pad weight test from baseline to 36 months following treatment schedule.	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.	Baseline, 3, 6, 12, 18, 24, 30 and 36 months

Collaborators and Investigators

• Sponsor: Adrian Gaspar
• Collaborators: Fotona d.o.o.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2015
• Primary Completion (ACTUAL): September 1, 2018
• Study Completion (ACTUAL): December 31, 2018

Study Registration Dates

• First Submitted: April 14, 2020
• First Submitted That Met QC Criteria: April 15, 2020
• First Posted (ACTUAL): April 16, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 17, 2020
• Last Update Submitted That Met QC Criteria: April 15, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: stress urinary incontinence; non-ablative Er:YAG laser
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: SUI/01/2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No