Clinical trial NCT05344716: FotonaSmooth Erbium:YAG Laser for the Treatment of Urethral Pain Syndrome in Women
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pelvic Pain Syndrome
Keywords: urethra
pain
laser
intraurethral
erbium
fotona
Lead sponsor: Cantonal Hospital, Frauenfeld
Sponsor class: OTHER
First posted: 2022-04-25
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: Urethral pain syndrome (UPS) is characterized by recurrent or persistent symptoms such as urethral or pelvic pain, daytime frequency and nocturia with unclear aetiology are diagnosed as UPS. Chronic infection by fastidious bacteria leading to chronic inflammation and pain may also cause UPS. Due to the unclear aetiology, the optimal treatment is challenging. It is therefore essential to find new and effective treatment options for patients suffering from UPS. Over the last few years, the use of lasers has become more popular to treat gynaecological and urogynecological conditions including stress urinary incontinence (SUI), genitourinary syndrome of menopause (GSM), vaginal prolapse and other conditions. In several trials, vaginal laser therapy has been shown to have a very good effect on SUI and GSM. Very few publications are available on the use of intraurethral laser therapy for the treatment of SUI and GSM with promising results. This is the first study to test the effect of intraurethral and vaginal laser therapy for the treatment of UPS. The hypothesis is that symptoms can be relieved in patients with UPS i.e. a reduction of urethral pressure pain upon palpation can be achieved.

Eligibility 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

Primary outcomes:
measure: Number of patients showing improvement in symptoms due to laser treatment
timeFrame: 5 months
Secondary outcomes:
measure: Number of patients showing improvement (reduction) in induration after treatment
timeFrame: 5 months
measure: Number of patients showing improvement (reduction in questionnaire sum) in symptoms as assed by subjective questionnaire
timeFrame: 5 months, 12 months
measure: Number of patients reporting pain during laser treatment
timeFrame: 3 months
measure: Number of patients showing urethral infections before and after treatment
timeFrame: 5 months
measure: Number of patients reporting satisfaction with treatment outcome
timeFrame: 5 months, 12 months
Other outcomes:
measure: Number of patients reprting good tolerability ("good" or "very good") of vulvar creams in combination with laser treatment
timeFrame: 5 months
Locations:
city: Frauenfeld
country: Switzerland
facility: Cantonal Hospital Frauenfeld
state: Thurgau
Study officials:
affiliation: Cantonal Hospital, Frauenfeld
name: Volker Viereck, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gaspar A, Maestri S, Silva J, Brandi H, Luque D, Koron N, Vizintin Z. Intraurethral Erbium:YAG laser for the management of urinary symptoms of genitourinary syndrome of menopause: A pilot study. Lasers Surg Med. 2018 Oct;50(8):802-807. doi: 10.1002/lsm.22826. Epub 2018 Apr 18.
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