Laser treatment for urethral pain in women
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
This study is testing a new laser treatment for women with urethral pain to see if it can help reduce their discomfort after other treatments haven't worked.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Cantonal Hospital, Frauenfeld Academic / other |
| Locations | 1 site (Frauenfeld, Thurgau) |
| Trial ID | NCT05344716 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adult females aged 18 and older with a history of urethral pressure pain and no significant improvement from prior conservative treatments.
Not a fit: Patients with acute infections, certain pre-existing conditions, or those currently pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide significant relief for women suffering from chronic urethral pain.
How similar studies have performed: While there have been successful studies on vaginal laser therapy for other conditions, this specific approach for urethral pain syndrome is novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Frauenfeld, Thurgau
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.