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 (UPS-IUL)

  • STATUS
    Recruiting
  • End date
    Dec 17, 2026
  • participants needed
    30
  • sponsor
    Prof. Dr. Volker Viereck
Updated on 17 October 2022

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.

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.

Details
Condition Pelvic Pain Syndrome
Treatment Laser
Clinical Study IdentifierNCT05344716
SponsorProf. Dr. Volker Viereck
Last Modified on17 October 2022

Eligibility

Yes No Not Sure

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
Clear my responses

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