Long-term Effectiveness of Non-ablative Er: YAG Laser for Treatment of

Status Completed

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).

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04348994
Study type	Interventional
Source	Espacio Gaspar Clinic
Contact
Status	Completed
Phase	N/A
Start date	March 1, 2015
Completion date	December 31, 2018

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms