FotonaSmooth Erbium:YAG Laser for the Treatment of Urethral Pain Syndrome in Women (UPS-IUL)

Prof. Dr. Volker Viereck

Status: Enrolling

Conditions: Pelvic Pain Syndrome

Treatments: Device: Laser

Study type: Interventional

Funder types: Other

Identifiers

NCT05344716

Pilot UPS-IUL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Laser

Experimental group

Description:

Intraurethral and vaginal laser treatment

Treatment:

Device: Laser