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

Stress Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04348994
• Other study ID #: SUI/01/2015
• Status: Completed
• Phase: N/A
• Start date: March 1, 2015
• Est. completion date: December 31, 2018

Study information

• Verified date: April 2020
• Source: Espacio Gaspar Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: December 31, 2018
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Adrian Gaspar	Fotona d.o.o.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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