Laser treatment for urethral pain in women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness of intraurethral and vaginal laser therapy for women suffering from urethral pain syndrome (UPS), characterized by persistent or recurrent urethral pain without clear pathology. The research aims to determine if this innovative laser treatment can significantly reduce urethral pressure pain. Participants will undergo laser therapy after failing previous conservative treatments, with the hypothesis that their symptoms will improve. This is the first trial to explore this specific laser approach for UPS.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Where it's running

• Blasenzentrum der Frau AG
  Frauenfeld, Thurgau, Switzerland Recruiting

Study contacts

• Principal investigator: Volker Viereck, Prof. Dr. — Blasenzentrum der Frau AG
• Study coordinator: Volker Viereck, Prof. Dr.
• Email: volker.viereck@blasenzentrum-der-frau.ch
• Phone: +41 52 511 20 20

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.