Pilot study to investigate the effect of laser treatment in urethral pain syndrome in women

ID di studio ICTRP
NCT05344716 (ICTRP)

Titolo ufficiale (approvato dal comitato etico)
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. Pilot Urethral Pain Syndrome - Intraurethral Laser study (Pilot UPS-IUL Study) (BASEC)

Titolo accademico
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 (ICTRP)

Titolo pubblico
FotonaSmooth Erbium:YAG Laser for the Treatment of Urethral Pain Syndrome in Women (ICTRP)

Malattie studiate
Pelvic Pain Syndrome
(ICTRP)

Intervento studiato
Device: Laser
(ICTRP)

Tipo di studio
Interventional (ICTRP)

Disegno dello studio
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)

Criteri di inclusione/esclusione

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
(ICTRP)

non disponibile

Endpoint primari e secondari
Number of patients showing improvement in symptoms due to laser treatment
(ICTRP)

Number of patients reporting pain during laser treatment
Number of patients reporting satisfaction with treatment outcome
Number of patients showing urethral infections before and after treatment
Number of patients showing improvement (reduction in questionnaire sum) in symptoms as assed by subjective questionnaire
Number of patients showing improvement (reduction) in induration after treatment
(ICTRP)

Data di registrazione
30.03.2022 (ICTRP)

Inclusione del primo partecipante
01.09.2022 (ICTRP)

Sponsor secondari
non disponibile

Contatti aggiuntivi
Volker Viereck, Prof. Dr., volker.viereck@stgag.ch, +41 52 723 70 60 (ICTRP)

ID secondari
Pilot UPS-IUL (ICTRP)

Risultati-Dati individuali dei partecipanti
non disponibile

Ulteriori informazioni sullo studio
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT05344716 (ICTRP)