FotonaSmooth Erbium:YAG Laser for the Treatment of Urethral Pain Syndrome in Women
ConditionPelvic Pain Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorProf. Dr. Volker Viereck
About this trial
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.
Eligibility criteria
Qualifiers
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.)
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Laser
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Prof. Dr. Volker Viereck
Lead sponsor
Cantonal Hospital, Frauenfeld
Sponsor institution
Source ClinicalTrials.gov