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

Adrian Gaspar

Status: Completed

Conditions: Stress Urinary Incontinence

Treatments: Device: Non-ablative thermal-only Er:YAG laser therapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04348994

SUI/01/2015

Details and patient eligibility

About

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).

Full 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).

Enrollment: 43 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

43 participants in 1 patient group

Laser therapy

Experimental group

Description:

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

Treatment:

Device: Non-ablative thermal-only Er:YAG laser therapy