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Pelvic Pain SyndromeUPS-IULNCT05344716

FotonaSmooth Erbium:YAG Laser for the Treatment of Urethral Pain Syndrome in Women

A study testing Laser in people with Pelvic Pain Syndrome, run by Prof. Dr. Volker Viereck at 1 site in Switzerland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Urethral pain syndrome (UPS) is defined by the occurrence of persistent or recurrent episodic urethral pain in the absence of proven infection or other obvious pathology. The objective of this study is to determine the effect of an intraurethral and vaginal laser therapy for the treatment of UPS. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Pelvic Pain Syndrome
What is being tested?
Laser
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteSwitzerland
Study dates
1 Sep 2022to Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult female, 18 years of age or older
  • Urethral pressure pain upon palpation, VAS Score ≥ 2
  • Intermittent or chronic pain in the urethra and/or the small pelvis (independent of micturition) 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

Who cannot join

  • Pregnancy
  • Treatment with Isotretinoin (Acne, Rosacea) within last 6 months
  • Acute urinary tract infection or other acute infection of the bladder, vagina, vulva or urinary tract detected by routine urine analysis
  • Positive urethral swab for Ureaplasma, Mycoplasma or Chlamydia ≤ 6 weeks. Exception: Patients with chronic and persistent fastidious bacteria can be included six weeks after two unsuccessful treatments with antibiotics. Antibiotics therapy must also include sexual partners.
  • Pre-existing bladder or urethra pathology
  • Interstitial Cystitis
Show all 12Show fewer
  • Endometriosis
  • Diagnosis of collagen disorders, e.g. benign joint hypermobility / Elhers-Danlos / Marfans etc.
  • Vesicovaginal fistula
  • Unwillingness or inability to complete follow-up schedule
  • Unwillingness or inability to give informed consent
  • Unwillingness or inability to complete questionnaires

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Volker Viereck, Prof. Dr. contact

+41 52 511 20 20

volker.viereck@blasenzentrum-der-frau.ch

Switzerland1 site, 1 recruiting

  • Blasenzentrum der Frau AG

    Frauenfeld, Thurgau, 8500

    Volker Viereck, MD, +41 52 511 20 20, volker.viereck@blasenzentrum-der-frau.ch

    Marianne Gamper, PhD, marianne.gamper@blasenzentrum-der-frau.ch

    Recruiting

Other trials in Switzerland

About this study

Official title: 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

Urethral pain syndrome (UPS) is defined by the occurrence of persistent or recurrent episodic urethral pain in the absence of proven infection or other obvious pathology. The objective of this study is to determine the effect of an intraurethral and vaginal laser therapy for the treatment of UPS. The hypothesis is that a significant reduction of urethral pressure pain can be achieved.

Read the detailed description

Urethral pain syndrome (UPS) is characterized by recurrent or persistent symptoms such as urethral or pelvic pain, daytime frequency and nocturia with unclear aetiology are diagnosed as UPS. Chronic infection by fastidious bacteria leading to chronic inflammation and pain may also cause UPS. Due to the unclear aetiology, the optimal treatment is challenging. It is therefore essential to find new and effective treatment options for patients suffering from UPS. Over the last few years, the use of lasers has become more popular to treat gynaecological and urogynecological conditions including stress urinary incontinence (SUI), genitourinary syndrome of menopause (GSM), vaginal prolapse and other conditions. In several trials, vaginal laser therapy has been shown to have a very good effect on SUI and GSM. Very few publications are available on the use of intraurethral laser therapy for the treatment of SUI and GSM with promising results. This is the first study to test the effect of intraurethral and vaginal laser therapy for the treatment of UPS. The hypothesis is that symptoms can be relieved in patients with UPS i.e. a reduction of urethral pressure pain upon palpation can be achieved.

Being tested
Laser
Keywords
urethra, pain, laser, intraurethral, erbium, fotona
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LaserDevice

    Intraurethral and vaginal laser treatment

Study groups in NCT05344716
Study groupRoleWhat they receive
LaserExperimentalIntraurethral and vaginal laser treatment
Receives: Device: Laser

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients showing improvement in symptoms due to laser treatment

    Reduction of urethral pressure pain upon palpation (visual analogue scale, 0-10 where 0 is none and 10 the worst), cure/improvement defined as >50% reduction compared to baseline

    Measured: 5 months

Secondary outcomes (5)

  1. Number of patients showing improvement (reduction) in induration after treatment

    digital testing of pelvic induration by physician (scale: high, moderate, none) compared to baseline

    Measured: 5 months

  2. Number of patients showing improvement (reduction in questionnaire sum) in symptoms as assed by subjective questionnaire

    subjective evaluation by validated questionnaire (Genitourinary Pain Index for Women, sum scale 0-45, the lower the value the lower the symptoms) compared to baseline

    Measured: 5 months, 12 months

  3. Number of patients reporting pain during laser treatment

    VAS (visual analogue scale, 0-10 where 0 is none and 10 the worst) pain score during laser treatment

    Measured: 3 months

  4. Number of patients showing urethral infections before and after treatment

    Analysis of urethral infections before and after treatment using urine dipstick test (positive/negative)

    Measured: 5 months

  5. Number of patients reporting satisfaction with treatment outcome

    subjective evaluation of improvement (patient global index fo improvement, 7-item scale from "very much worse" to "very much better"), cure/improvement defined as response "much better" or "very much better"

    Measured: 5 months, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2022
  2. Study start1 Sep 2022
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05344716
Sponsor's protocol ID
Pilot UPS-IUL
Acronym
UPS-IUL
Status last verified
Mar 2026
First submitted
30 Mar 2022
Last updated
23 Mar 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gaspar A, Maestri S, Silva J, Brandi H, Luque D, Koron N, Vizintin Z. Intraurethral Erbium:YAG laser for the management of urinary symptoms of genitourinary syndrome of menopause: A pilot study. Lasers Surg Med. 2018 Oct;50(8):802-807. doi: 10.1002/lsm.22826. Epub 2018 Apr 18.

    PubMed 29667744

  • Gaspar A, Brandi H. Non-ablative erbium YAG laser for the treatment of type III stress urinary incontinence (intrinsic sphincter deficiency). Lasers Med Sci. 2017 Apr;32(3):685-691. doi: 10.1007/s10103-017-2170-5. Epub 2017 Feb 16.

    PubMed 28210823

  • Gaspar A, Silva J, Silva G, Anchelerguez R, Prats J, Sagaz A, Rovere E, Alastra M, Pino J, Jauregui A, Farrugia M, Villaroel F, Guareschi J, Vega M, Biasiori E, Moyano E, La Rosa A, Hreljac I, Vizintin Z. Nonablative transurethral Erbium:YAG laser treatment for chronic prostatitis/chronic pelvic pain syndrome: A prospective comparative study. Neurourol Urodyn. 2021 Jan;40(1):278-285. doi: 10.1002/nau.24551. Epub 2020 Nov 10.

    PubMed 33170523

  • Kuszka A, Gamper M, Walser C, Kociszewski J, Viereck V. Erbium:YAG laser treatment of female stress urinary incontinence: midterm data. Int Urogynecol J. 2020 Sep;31(9):1859-1866. doi: 10.1007/s00192-019-04148-9. Epub 2019 Dec 11.

    PubMed 31828400

  • Yoon SM, Jung JK, Lee SB, Lee T. Treatment of female urethral syndrome refractory to antibiotics. Yonsei Med J. 2002 Oct;43(5):644-51. doi: 10.3349/ymj.2002.43.5.644.

    PubMed 12402379

  • Kaur H, Arunkalaivanan AS. Urethral pain syndrome and its management. Obstet Gynecol Surv. 2007 May;62(5):348-51; quiz 353-4. doi: 10.1097/01.ogx.0000261645.12099.2a.

    PubMed 17425813

  • Gambacciani M, Levancini M. Short-term effect of vaginal erbium laser on the genitourinary syndrome of menopause. Minerva Ginecol. 2015 Apr;67(2):97-102.

    PubMed 25763800

  • Gambacciani M, Levancini M, Cervigni M. Vaginal erbium laser: the second-generation thermotherapy for the genitourinary syndrome of menopause. Climacteric. 2015 Oct;18(5):757-63. doi: 10.3109/13697137.2015.1045485.

    PubMed 26029987

  • Fistonic N, Fistonic I, Gustek SF, Turina IS, Marton I, Vizintin Z, Kazic M, Hreljac I, Perhavec T, Lukac M. Minimally invasive, non-ablative Er:YAG laser treatment of stress urinary incontinence in women--a pilot study. Lasers Med Sci. 2016 May;31(4):635-43. doi: 10.1007/s10103-016-1884-0. Epub 2016 Feb 9.

    PubMed 26861984

  • Fistonic I, Fistonic N. Baseline 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. Lasers Surg Med. 2018 Jan 23. doi: 10.1002/lsm.22789. Online ahead of print.

    PubMed 29360142

  • Gambacciani M, Levancini M, Russo E, Vacca L, Simoncini T, Cervigni M. Long-term effects of vaginal erbium laser in the treatment of genitourinary syndrome of menopause. Climacteric. 2018 Apr;21(2):148-152. doi: 10.1080/13697137.2018.1436538. Epub 2018 Feb 13.

    PubMed 29436235

  • Blaganje M, Scepanovic D, Zgur L, Verdenik I, Pajk F, Lukanovic A. Non-ablative Er:YAG laser therapy effect on stress urinary incontinence related to quality of life and sexual function: A randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2018 May;224:153-158. doi: 10.1016/j.ejogrb.2018.03.038. Epub 2018 Mar 22.

    PubMed 29604548

Questions about this trial

What is this clinical trial studying?

A study testing Laser in people with Pelvic Pain Syndrome, run by Prof. Dr. Volker Viereck at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Volker Viereck, Prof. Dr. (+41 52 511 20 20, volker.viereck@blasenzentrum-der-frau.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients showing improvement in symptoms due to laser treatment (time frame: 5 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05344716, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.

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