Evidence map›Paper›PMID 26861984›Full record

ArticleLasers in medical science2016

Minimally invasive, non-ablative Er:YAG laser treatment of stress urinary incontinence in women--a pilot study.

Nikola Fistonić, Ivan Fistonić, Štefica Findri Guštek, Iva Sorta Bilajac Turina, Ingrid Marton, Zdenko Vižintin, Marko Kažič, Irena Hreljac, Tadej Perhavec, Matjaž Lukač

2 registry-linked trialsOpen access · hybridAbstract read
In one paragraph

Article in Lasers in medical science, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 49 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
49citing papers in PubMed, 4 pooled it
16.2field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03301142 naunknown statusnot on this map

Randomized Trial Comparing the Use of Laser and of Kinesiotherapy for the Treatment of Female Stress Urinary Incontinence - a Pilot Study

TypeinterventionalSponsorUniversity of Sao Paulo General HospitalRan2015 to 2018Enrolled40ConditionsUrinary Stress IncontinenceArmsLaser, kinesiotherapy
NCT05344716 narecruitingnot on this mapstarted 2022, after this paper: background citation

Monocentric, Prospective Pilot Study to Test the Efficacy and Safety of the FotonaSmooth Erbium:YAG Laser for the Treatment of Urethral Pain Syndrome in Women

TypeinterventionalSponsorProf. Dr. Volker ViereckRan2022 to 2027Enrolled30ConditionsPelvic Pain SyndromeArmsLaser
3 · Its place in the literature

Who cites it

49 citing papers in PubMed, 4 syntheses or guidelines pooled it, 136 citations in OpenAlex.

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  10. Prospective trial of a 2940 nm Er:YAG laser for the treatment of meibomian gland dysfunction.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2021
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 3 institutions in 2 countries.

Nikola FistonićOb/Gyn Clinic, University Hospital Merkur, Zagreb, Croatia.
Ivan FistonićOb/Gyn and Menopause Clinic, Zagreb, Croatia.
Štefica Findri GuštekOb/Gyn and Menopause Clinic, Zagreb, Croatia.
Iva Sorta Bilajac TurinaMedical School University of Rijeka, Rijeka, Croatia.
Ingrid MartonDepartment of Obstetrics and Gynecology, General Hospital Sveti Duh, Zagreb, Croatia.
Zdenko VižintinFotona d.o.o., Stegne 7, 1000, Ljubljana, Slovenia.
Marko KažičFotona d.o.o., Stegne 7, 1000, Ljubljana, Slovenia.
Irena HreljacFotona d.o.o., Stegne 7, 1000, Ljubljana, Slovenia. irena.hreljac@fotona.com.
Tadej PerhavecFotona d.o.o., Stegne 7, 1000, Ljubljana, Slovenia.
Matjaž LukačFotona d.o.o., Stegne 7, 1000, Ljubljana, Slovenia.
Fotona (Slovenia) · SIKlinička bolnica Merkur · HRUniversity of Rijeka · HR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The study presents an assessment of mechanism of action and a pilot clinical study of efficacy and safety of the Er:YAG laser for the treatment of stress urinary incontinence (SUI). The subject of this study is a treatment of SUI with a 2940 nm Er:YAG laser, operating in a special SMOOTH mode designed to increase temperature of the vaginal mucosa up to maximally 60-65 °C without ablating the epidermis. Numerical modelling of the temperature distribution within mucosa tissue following an irradiation with the SMOOTH mode Er:YAG laser was performed in order to determine the appropriate range of laser parameters. The laser treatment parameters were further confirmed by measuring in vivo temperatures of the vaginal mucosa using a thermal camera. To investigate the clinical efficacy and safety of the SMOOTH mode Er:YAG laser SUI treatment, a pilot clinical study was performed. The study recruited 31 female patients suffering from SUI. Follow-ups were scheduled at 1, 2, and 6 months post treatment. ICIQ-UI questionnaires were collected as a primary trial endpoint. Secondary endpoints included perineometry and residual urine volume measurements at baseline and all follow-ups. Thermal camera measurements have shown the optimal increase in temperature of the vaginal mucosa following treatment of SUI with a SMOOTH mode Er:YAG laser. Primary endpoint, the change in ICIQ-UI score, showed clinically relevant and statistically significant improvement after all follow-ups compared to baseline scores. There was also improvement in the secondary endpoints. Only mild and transient adverse events and no serious adverse events were reported. The results indicate that non-ablative Er:YAG laser therapy is a promising minimally invasive non-surgical option for treating women with SUI symptoms.

Indexed as

Low-Level Light TherapyAdultFemaleHumansLasers, Solid-StateMiddle AgedPilot ProjectsTreatment OutcomeUrinary Incontinence, StressEr:YAG laserMinimally invasive SUI therapyStress urinary incontinence

Identifiers

PMID26861984
PMCPMC4851697
OpenAlexW2258755415

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.