HumRes60929
|
SNCTP000005016
|
BASEC2022-D0049
|
NCT05344716
Pilot study to investigate the effect of laser treatment in urethral pain syndrome in women
Résumé de l'étude
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)
Intervention étudiée
Laser treatment of the inside of the urethra, vagina, and external genitalia.
(BASEC)
Maladie en cours d'investigation
Urethral pain syndrome
(BASEC)
Critères de participation
Women aged 18 and older with typical symptoms of urethral pain syndrome can participate in this study. (BASEC)
Critères d'exclusion
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)
Critères d'exclusion
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)
Lieu de l’étude
Autre
(BASEC)
Frauenfeld
(BASEC)
Switzerland (ICTRP)
Sponsor
Prof. Dr. med. Volker Viereck
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Prof. Dr. med. Volker Viereck
+41 52 511 20 21
volker.viereck@clutterblasenzentrum-der-frau.chBlasenzentrum der Frau AG
(BASEC)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Ethikkommission Ostschweiz EKOS
(BASEC)
Date d'approbation du comité d'éthique
09.06.2022
(BASEC)
Identifiant de l'essai ICTRP
NCT05344716 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
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)
Titre académique
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)
Titre public
FotonaSmooth Erbium:YAG Laser for the Treatment of Urethral Pain Syndrome in Women (ICTRP)
Maladie en cours d'investigation
Pelvic Pain Syndrome
(ICTRP)
Intervention étudiée
Device: Laser
(ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Critères d'inclusion/exclusion
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 disponible
Critères d'évaluation principaux et secondaires
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)
Date d'enregistrement
30.03.2022 (ICTRP)
Inclusion du premier participant
01.09.2022 (ICTRP)
Sponsors secondaires
non disponible
Contacts supplémentaires
Volker Viereck, Prof. Dr., volker.viereck@stgag.ch, +41 52 723 70 60 (ICTRP)
ID secondaires
Pilot UPS-IUL (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT05344716 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible