HumRes60929
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SNCTP000005016
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BASEC2022-D0049
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NCT05344716
Pilot study to investigate the effect of laser treatment in urethral pain syndrome in women
Summary description of the study
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 under investigation
Laser treatment of the inside of the urethra, vagina, and external genitalia.
(BASEC)
Disease under investigation
Urethral pain syndrome
(BASEC)
Criteria for participation in trial
Women aged 18 and older with typical symptoms of urethral pain syndrome can participate in this study. (BASEC)
Exclusion criteria
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)
Exclusion criteria
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)
Trial sites
Other
(BASEC)
Frauenfeld
(BASEC)
Switzerland (ICTRP)
Sponsor
Prof. Dr. med. Volker Viereck
(BASEC)
Contact
Contact Person Switzerland
Prof. Dr. med. Volker Viereck
+41 52 511 20 21
volker.viereck@clutterblasenzentrum-der-frau.chBlasenzentrum der Frau AG
(BASEC)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethikkommission Ostschweiz EKOS
(BASEC)
Date of authorisation
09.06.2022
(BASEC)
ICTRP Trial ID
NCT05344716 (ICTRP)
Official title (approved by ethics committee)
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)
Academic title
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)
Public title
FotonaSmooth Erbium:YAG Laser for the Treatment of Urethral Pain Syndrome in Women (ICTRP)
Disease under investigation
Pelvic Pain Syndrome
(ICTRP)
Intervention under investigation
Device: Laser
(ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Inclusion/Exclusion criteria
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)
not available
Primary and secondary end points
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)
Registration date
30.03.2022 (ICTRP)
Incorporation of the first participant
01.09.2022 (ICTRP)
Secondary sponsors
not available
Additional contacts
Volker Viereck, Prof. Dr., volker.viereck@stgag.ch, +41 52 723 70 60 (ICTRP)
Secondary trial IDs
Pilot UPS-IUL (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT05344716 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available