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NCT06559423
Combined Non-ablative Er:YAG Laser and Magnetic Stimulation for Treatment of Female Urinary Incontinence
NA trial testing non-ablative Er:YAG laser and high intensity Tesla magnetic stimulation (HITS) in Stress Urinary Incontinence in 25 participants. Completed in 21 October 2022.
21 October 2022
Quick facts
| Lead sponsor | Zdravstveni Zavod Štrumbelj |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 25 |
| Start date | 23 April 2021 |
| Primary completion | 21 October 2022 |
| Estimated completion | 21 October 2022 |
| Sites | 1 location across Slovenia |
Drugs / interventions tested
- non-ablative Er:YAG laser and high intensity Tesla magnetic stimulation (HITS)
Conditions studied
- Stress Urinary Incontinence — all drugs for Stress Urinary Incontinence →
- Urinary Incontinence — all drugs for Urinary Incontinence →
Sponsor
Zdravstveni Zavod Štrumbelj
Who can join
Adults 18 to 80, female only, with Stress Urinary Incontinence or Urinary Incontinence. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This single-arm pilot study aims to investigate the efficacy and safety of a combined non-ablative Erbium:Yttrium-Aluminium-Garnet (Er:YAG) laser and High Intensity Tesla magnetic Stimulation (HITS) treatment for female urinary incontinence. The study involves 25 women diagnosed with mild to moderate stress or mixed urinary incontinence. Participants will receive three vaginal Er:YAG laser treatments and six HITS sessions. The primary objective is to improve symptoms of urinary incontinence, as measured by changes in scores on two questionnaires compared to baseline. Secondary objectives include improvement in sexual function, durability of improvement in urinary incontinence symptoms at 3- and 6- month follow-up, patient-reported improvement, and discomfort during treatment.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06559423
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06559423 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Zdravstveni Zavod Štrumbelj
- Last refreshed: 19 August 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06559423.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing