FotonaSmooth Erbium:YAG Laser for the Treatment of Urethral Pain Syndrome in Women (NCT05344716) | Clinical Trial Compass
RecruitingNot Applicable
FotonaSmooth Erbium:YAG Laser for the Treatment of Urethral Pain Syndrome in Women
Switzerland30 participantsStarted 2022-09-01
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Number of patients showing improvement in symptoms due to laser treatment