Intraurethral Erbium:YAG laser for the management of urinary symptoms of genitourinary syndrome of menopause: A pilot study.
Adrian Gaspar, Sandra Maestri, Joaquin Silva...
https://pubmed.ncbi.nlm.nih.gov/29667744Actively Recruiting
Phase Not Applicable
Age: 18Years +
FEMALE
ID05344716
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
Led by Prof. Dr. Volker Viereck · Updated on 2026-03-23
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Pelvic Pain Syndrome, specifically Urethral Pain Syndrome (UPS), involves persistent or recurring urethral pain without infection or clear cause. This study aims to evaluate the effects of intraurethral and vaginal laser therapy on reducing urethral pressure pain in women with UPS. The research explores a new treatment option because existing therapies often show limited improvement, and laser therapy has shown promise in related gynecological conditions. Participants will receive intraurethral and vaginal laser treatment using the FotonaSmooth Erbium:YAG laser. This is a single-center, prospective pilot study designed to assess the safety and effectiveness of this laser therapy for UPS. The treatment process involves laser application directly to the urethral and vaginal areas, aiming to relieve symptoms and reduce pain. During the study, women will be monitored over several months with assessments including symptom improvement, reduction in tissue induration, pain levels during treatment, infection status, and satisfaction with treatment outcomes. These evaluations will occur at 3, 5, and 12 months after treatment. Participants will complete questionnaires and undergo clinical examinations to track progress and safety, with the total follow-up period extending up to 12 months.
CONDITIONS
Brief Title
FotonaSmooth Erbium:YAG Laser for the Treatment of Urethral Pain Syndrome in Women
Who Can Participate
Age: 18Years +
FEMALE
Eligibility Criteria
You may qualify if you...
- Adult female, 18 years of age or older
- Urethral pressure pain upon palpation, VAS Score 2 2
- Intermittent or chronic pain in the urethra and/or the small pelvis for at least 6 months
- No significant improvement of UPS from at least one previous conservative treatment (pessary, antibiotics, local oestrogens etc.)
- Signed informed consent
You will not qualify if you...
- Pregnancy
- Treatment with Isotretinoin within last 6 months
- Acute urinary tract infection or other acute infection of the bladder, vagina, vulva or urinary tract
- Positive urethral swab for Ureaplasma, Mycoplasma or Chlamydia 2 6 weeks, except in specified chronic cases
- Pre-existing bladder or urethra pathology
- Interstitial Cystitis
- Endometriosis
- Diagnosis of collagen disorders such as benign joint hypermobility, Elhers-Danlos, or Marfans
- Vesicovaginal fistula
- Unwillingness or inability to complete follow-up schedule
- Unwillingness or inability to give informed consent
- Unwillingness or inability to complete questionnaires
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Single treatment session
Participants receive intraurethral and vaginal laser treatment for urethral pain syndrome.
1 visit (in-person)
Follow-up
Duration - Up to 12 months
Participants are monitored to assess improvement in symptoms and treatment satisfaction after laser therapy.
Follow-up visits at 3, 5, and 12 months post-treatment
Trial Site Locations
Total: 1 location
1
Blasenzentrum der Frau AG
Frauenfeld, Thurgau, Switzerland, 8500
Actively Recruiting
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Research Team
V
Volker Viereck, Prof. Dr.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Non-ablative erbium YAG laser for the treatment of type III stress urinary incontinence (intrinsic sphincter deficiency).
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https://pubmed.ncbi.nlm.nih.gov/28210823Nonablative transurethral Erbium:YAG laser treatment for chronic prostatitis/chronic pelvic pain syndrome: A prospective comparative study.
Adrián Gaspar, Joaquín Silva, Gustavo Silva...
https://pubmed.ncbi.nlm.nih.gov/33170523Erbium:YAG laser treatment of female stress urinary incontinence: midterm data.
Andrzej Kuszka, Marianne Gamper, Claudia Walser...
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Sang Min Yoon, Jong Kwon Jung, Sang Bong Lee...
https://pubmed.ncbi.nlm.nih.gov/12402379Urethral pain syndrome and its management.
Hervinder Kaur, Angamuthu S Arunkalaivanan
https://pubmed.ncbi.nlm.nih.gov/17425813Short-term effect of vaginal erbium laser on the genitourinary syndrome of menopause.
M Gambacciani, M Levancini
https://pubmed.ncbi.nlm.nih.gov/25763800Vaginal erbium laser: the second-generation thermotherapy for the genitourinary syndrome of menopause.
M Gambacciani, M Levancini, M Cervigni
https://pubmed.ncbi.nlm.nih.gov/26029987Minimally invasive, non-ablative Er:YAG laser treatment of stress urinary incontinence in women--a pilot study.
Nikola Fistonić, Ivan Fistonić, Štefica Findri Guštek...
https://pubmed.ncbi.nlm.nih.gov/26861984Baseline ICIQ-UI score, body mass index, age, average birth weight, and perineometry duration as promising predictors of the short-term efficacy of Er:YAG laser treatment in stress urinary incontinent women: A prospective cohort study.
Ivan Fistonić, Nikola Fistonić
https://pubmed.ncbi.nlm.nih.gov/29360142