Evidence map›Paper›PMID 29667744›Full record

Trial reportLasers in surgery and medicine2018

Intraurethral Erbium:YAG laser for the management of urinary symptoms of genitourinary syndrome of menopause: A pilot study.

Adrian Gaspar, Sandra Maestri, Joaquin Silva, Hugo Brandi, Daniel Luque, Neža Koron, Zdenko Vižintin

Registry-linked trialOpen access · hybridAbstract readClinical Trial
In one paragraph

Trial report in Lasers in surgery and medicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05344716 (Monocentric, Prospective Pilot Study to Test the Efficacy and Safety of the FotonaSmooth Erbium), which is not on this map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
3.4field-weighted citation impact, top 7% 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.

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

16 citing papers in PubMed, 44 citations in OpenAlex.

  1. Trial
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  11. Review
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  13. Review
  14. The use of laser in urogynaecology.International urogynecology journal · 2019
    Review
  15. Review
  16. Review
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

7 authors at 4 institutions in 2 countries.

Adrian GasparEspacio Gaspar Clinic, Olascoaga 881, 5500, Mendoza, Argentina.
Sandra MaestriEspacio Gaspar Clinic, Olascoaga 881, 5500, Mendoza, Argentina.
Joaquin SilvaUroclinica Mendoza, Paso de Los Andes, 5500, Mendoza, Argentina.
Hugo BrandiEspacio Gaspar Clinic, Olascoaga 881, 5500, Mendoza, Argentina.
Daniel LuqueEspacio Gaspar Clinic, Olascoaga 881, 5500, Mendoza, Argentina.
Neža KoronFotona d.o.o., Stegne 7, SI-1000, Ljubljana, Slovenia.
Zdenko VižintinFotona d.o.o., Stegne 7, SI-1000, Ljubljana, Slovenia.
Instituto de Histología y Embriología de Mendoza · ARFotona (Slovenia) · SICentro Científico Tecnológico - Mendoza · ARUniversity of Mendoza · AR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesGenitourinary syndrome of menopause (GSM) combines the conditions of vulvovaginal atrophy (VVA) and urinary tract dysfunction, which is a result of urethral atrophy. There are several treatment methods available for the management of vulvovaginal symptoms of GSM, whereas urinary tract dysfunction often remains overlooked and undertreated. The objective of this pilot study was to assess the safety and efficacy of intraurethral Er:YAG laser treatment of urinary symptoms of GSM. PATIENTS AND

methodsPatients with diagnosed GSM, having less than 5% of vaginal superficial cells in the cytology, vaginal pH higher than 5, with urinary symptoms of GSM (dysuria, frequency, urgency) and impaired continence due to urethral atrophy, received two sessions of intraurethral Er:YAG laser with a 3-week interval in-between the sessions. Laser energy was delivered in non-ablative way using Erbium SMOOTH™ mode technology and a 4-mm thick cannula. Therapeutic efficacy was determined using ICIQ-SF, the 1-hour pad test and VAS scores. Occurrence of adverse effects was followed at every visit. Follow ups (FU) were at 3 and 6 months.

results29 female patients fulfilling the inclusion criteria were included in this pilot study and received two sessions of the intraurethral non-ablative Erbium SMOOTH™ laser therapy. Significant improvement was observed in all measured parameters at both FU. ICIQ-SF improved by an average of 64% at 3 months FU and by 40% at 6 months. The 1-hour pad test showed a reduction of the quantity of leaked urine by 59% at 3 months FU and by 42% at 6 months FU. All urinary symptoms of GSM improved. Dysuria dropped to 13% and 31% of baseline values at three and 6 months respectively, urinary urgency dropped to 23% and 47% and frequency dropped to 22% and 43% after 3 and 6 months, respectively. Adverse effects were mild and transient.

conclusionsOur findings suggest that intraurethral Er:YAG laser is an efficacious and safe modality for treatment of urinary symptoms of GSM, however, prospective, randomized, and controlled trials with larger number of patients are needed to better assess the long-term effect of this novel procedure. Lasers Surg. Med. 50:802-807, 2018. © 2018 The Authors. Lasers in Surgery and Medicine Published by Wiley Periodicals, Inc.

Indexed as

MenopauseAgedFemaleFemale Urogenital DiseasesHumansLasers, Solid-StateLaser TherapyMiddle AgedPilot ProjectsProspective StudiesSyndromeErbium SMOOTH™ lasergenitourinary syndrome of menopauseimpaired continenceintraurethralurethral atrophy

Identifiers

PMID29667744
PMCPMC6175161
OpenAlexW2799465506

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.