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

NCT05344716 | Recruiting

• 1 other identifier: Pilot UPS-IUL
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. The hypothesis is that a significant reduction of urethral pressure pain can be achieved.

Conditions

Pelvic Pain Syndrome

Keywords

urethra; pain; laser; intraurethral; erbium; fotona

Outcome Measures

Primary Outcomes (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

  5 months

Secondary Outcomes (5)

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

  5 months

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

  5 months, 12 months

• Number of patients reporting pain during laser treatment

  3 months

• Number of patients showing urethral infections before and after treatment

  5 months

• Number of patients reporting satisfaction with treatment outcome

  5 months, 12 months

Other Outcomes (1)

• Number of patients reprting good tolerability ("good" or "very good") of vulvar creams in combination with laser treatment

  5 months

Study Arms (1)

Laser

EXPERIMENTAL

Intraurethral and vaginal laser treatment

Device: Laser

Interventions

Laser DEVICE

Intraurethral and vaginal laser treatment

Laser

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Prof. Dr. Volker Viereck: lead

Study Sites (1)

Blasenzentrum der Frau AG

Frauenfeld, Thurgau, 8500, Switzerland

RECRUITING

Related Publications (12)

• 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.

  PMID: 29667744 BACKGROUND

• 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.

  PMID: 28210823 BACKGROUND

• 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.

  PMID: 33170523 BACKGROUND

• 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.

  PMID: 31828400 BACKGROUND

• 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.

  PMID: 12402379 BACKGROUND

• 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.

  PMID: 17425813 BACKGROUND

• 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.

  PMID: 25763800 BACKGROUND

• 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.

  PMID: 26029987 BACKGROUND

• 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.

  PMID: 26861984 BACKGROUND

• 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.

  PMID: 29360142 BACKGROUND

• 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.

  PMID: 29436235 BACKGROUND

• 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.

  PMID: 29604548 BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Lasers

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Volker Viereck, Prof. Dr.

  Blasenzentrum der Frau AG

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Volker Viereck, Prof. Dr.

CONTACT

+41 52 511 20 20; volker.viereck@blasenzentrum-der-frau.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: March 30, 2022
• First Posted: April 25, 2022
• Study Start: September 1, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)