HumRes60929
|
SNCTP000005016
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BASEC2022-D0049
|
NCT05344716
Pilot study to investigate the effect of laser treatment in urethral pain syndrome in women
Zusammenfassung der Studie
We want to investigate the effect of a laser treatment applied in the urethra, vagina, and on the external genitalia. The patients will receive the laser treatment in 3 sessions spaced one month apart in the clinic.
(BASEC)
Untersuchte Intervention
Laser treatment of the inside of the urethra, vagina, and external genitalia.
(BASEC)
Untersuchte Krankheit(en)
Urethral pain syndrome
(BASEC)
Kriterien zur Teilnahme
Women aged 18 and older with typical symptoms of urethral pain syndrome can participate in this study. (BASEC)
Ausschlusskriterien
Patients who are pregnant, have an acute infection of the bladder or vagina, or have a pre-existing condition that makes laser treatment impossible are excluded. (BASEC)
Women aged 18 and older with typical symptoms of urethral pain syndrome can participate in this study. (BASEC)
Ausschlusskriterien
Patients who are pregnant, have an acute infection of the bladder or vagina, or have a pre-existing condition that makes laser treatment impossible are excluded. (BASEC)
Studienstandort
Andere
(BASEC)
Frauenfeld
(BASEC)
Switzerland (ICTRP)
Sponsor
Prof. Dr. med. Volker Viereck
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Prof. Dr. med. Volker Viereck
+41 52 511 20 21
volker.viereck@clutterblasenzentrum-der-frau.chBlasenzentrum der Frau AG
(BASEC)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Ostschweiz EKOS
(BASEC)
Datum der Bewilligung durch die Ethikkommission
09.06.2022
(BASEC)
ICTRP Studien-ID
NCT05344716 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
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)
Wissenschaftlicher Titel
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)
Öffentlicher Titel
FotonaSmooth Erbium:YAG Laser for the Treatment of Urethral Pain Syndrome in Women (ICTRP)
Untersuchte Krankheit(en)
Pelvic Pain Syndrome
(ICTRP)
Untersuchte Intervention
Device: Laser
(ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
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)
nicht verfügbar
Primäre und sekundäre Endpunkte
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)
Registrierungsdatum
30.03.2022 (ICTRP)
Einschluss des ersten Teilnehmers
01.09.2022 (ICTRP)
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Volker Viereck, Prof. Dr., volker.viereck@stgag.ch, +41 52 723 70 60 (ICTRP)
Sekundäre IDs
Pilot UPS-IUL (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT05344716 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar