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

NCT ID: NCT04348994

Last Updated: 2020-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-01
• Study Completion Date: 2018-12-31

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).

Conditions

Stress Urinary Incontinence

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Laser therapy

Non-ablative thermal-only Er:YAG laser treatment using IncontiLase® protocol.

Group Type: EXPERIMENTAL

Non-ablative thermal-only Er:YAG laser therapy

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

IncontiLase®

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fotona d.o.o.

INDUSTRY

Sponsor Role: collaborator

Adrian Gaspar

OTHER

Sponsor Role: lead

Responsible Party

Adrian Gaspar

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 35067817 (View on PubMed)

Other Identifiers

SUI/01/2015

Identifier Type: -

Identifier Source: org_study_id