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NCT03296241
Non-ablative Er:Yttrium Aluminum Garnet Laser for Stress Urinary Incontinence (SUI)
NA trial testing laser in Stress Urinary Incontinence in 114 participants. Completed in 30 August 2013.
30 August 2013
Quick facts
| Lead sponsor | Dr Adolf Lukanovič |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 114 |
| Start date | 1 August 2012 |
| Primary completion | 30 August 2013 |
| Estimated completion | 30 August 2013 |
Drugs / interventions tested
- laser
- sham control — full drug profile →
Conditions studied
- Stress Urinary Incontinence — all drugs for Stress Urinary Incontinence →
Sponsor
Dr Adolf Lukanovič — full company profile →
Who can join
Adults 35 to 65, female only, with Stress Urinary Incontinence. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Stress urinary incontinence (SUI) is a common complaint in women after childbirth. The aim of this study was to evaluate the efficacy and safety of non-ablative Er:YAG laser therapy in the treatment of SUI and improvement of sexual gratification in parous women. 114 premenopausal parous women with SUI were randomized in two groups of 57 women; a laser intervention group and sham control (placebo) group. Both groups were treated according to the IncontiLaseTM clinical treatment protocol for SUI with non-ablative thermal-only Er:YAG laser, except that there was no energy output when treating the sham group. Patients were blinded to the allocation. At baseline and 3 months after treatment patients were clinically examined, answered questionnaires for SUI severity sexual function assessment and their pelvic floor muscle (PFM) function was assessed with perineometry. The improvement in the laser group will be compared to the improvement in the sham group.
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 NCT03296241
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Currently open trials in the same condition.
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Other Dr Adolf Lukanovič trials
Trials by the same sponsor.
- NCT03525522 — Nd:Yttrium Aluminum Garnet Laser Treatment for Lichen Sclerosus · NA · unknown
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 NCT03296241 (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 Dr Adolf Lukanovič
- Last refreshed: 28 September 2017
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/NCT03296241.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing