CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
Laser therapyprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03996070
NCT03996070N/ACompleted

Randomised, Sham Controlled Trial of Fotona Smooth Erbium Yag Laser In the Treatment of Stress Urinary Incontinence

Hampshire Hospitals NHS Foundation Trust·interventional·Posted Jun 24, 2019·Updated Sep 22, 2025

In Brief

A clinical study evaluating Laser therapy for Female Stress Incontinence. Completed, enrolled 30 participants across 1 site.

Detailed Summary

Patients seen with stress urinary incontinence (SUI) that have failed conservative treatments will be offered to participate in a sham controlled RCT of outpatient therapy with the Fotona Smooth Erbium Yag laser. Patients will be randomised to either outpatient laser treatments or sham treatments. Patients will be blinded to which arm they have been randomised. Patients will be asked to complete appropriate relevant symptom and quality of life questionnaires prior to treatment and then at 6 and 12 months following the final treatment. At 6 months Sham patients will be un-blinded and offered the laser therapy if they wish.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJun 24, 2019
Enrollment StartJun 6, 2022
Primary CompletionNov 30, 2024
Study CompletionJun 30, 2025
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 7.0 years ago

Interventions

Laser therapyprocedure

Erbium YAG laser