Laser zaps leakage: new hope for stress incontinence?
NCT ID NCT03996070
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This completed trial tested whether a special laser (Fotona Smooth Erbium YAG) can help women with stress urinary incontinence who haven't improved with exercises. Thirty women were randomly assigned to get either real laser treatments or a fake (sham) procedure, and neither they nor their doctors knew which they received. The main goal was to see if the laser reduced urine leakage more than the sham treatment at 6 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Erbium YAG laser
- What this could lead to
- If it works, this could offer a non-surgical, outpatient option to reduce urine leakage in women with stress incontinence.
- What could go wrong
- This is a small, early-stage trial with only 30 participants, so results may not apply widely. The sham control helps, but the laser might not work better than placebo.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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30 people
The number who actually took part.
- Started
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Jun 2022
- Finished
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Jun 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Adult Female, 18 years of age or older 2. Clinical and UDS diagnosis of Stress Urinary Incontinence 3. SUI on 1-hour Pad weight test between 2g and 25g (SUI I: 2-10g, SUI II:11-25g) 4. No significant improvement in urinary incontinence from at least one previous conservative treatment, such as pelvic floor muscle training Exclusion Criteria: 1. Pre-existing bladder pathology including prior radiation treatment 2. Pregnancy 3. BMI\>35 4. Radical pelvic surgery or previous incontinence surgery 5. Urinary tract infection or other active infections of urinary tract or bladder 6. SUI on 1 hour pad weight test \>25g (SUI III: \>25g) 7. Any form of pelvic organ prolapse greater than stage 2, according to POP-Q 8. Diagnosis of urge incontinence 9. Diagnosis of collagen disorders eg.benign joint hypermobility / Elhers-Danlos / Marfans etc. 10. Incomplete bladder emptying 11. Vesicovaginal fistula 12. Faecal incontinence 13. Unwillingness or inability to complete follow-up schedule 14. Unwillingness or inability to give Informed Consent 15. Failure to comply with diary requirements during extended baseline period
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Basingstoke & North Hampshire Hospital
Basingstoke, Hampshire, RG24 9NA, United Kingdom