Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT05344716

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

273 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult female, 18 years of age or older
  • Urethral pressure pain upon palpation, VAS Score 65 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
Not Eligible

You will not qualify if you...

  • 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 64 6 weeks unless chronic and persistent bacteria with two failed antibiotic treatments
  • Pre-existing bladder or urethra pathology
  • Interstitial Cystitis
  • Endometriosis
  • Diagnosis of collagen disorders such as benign joint hypermobility, Elhers-Danlos, 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

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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.

CONTACT

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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