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NCT Number: NCT05344716

FotonaSmooth Erbium:YAG Laser for the Treatment of Urethral Pain Syndrome in Women

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laser

Device

Intraurethral and vaginal laser treatment

Primary outcomes

  1. Number of patients showing improvement in symptoms due to laser treatment

    Time frame: 5 months

    Reduction of urethral pressure pain upon palpation (visual analogue scale, 0-10 where 0 is none and 10 the worst), cure/improvement defined as >50% reduction compared to baseline

Secondary outcomes

  1. Number of patients showing improvement (reduction) in induration after treatment

    Time frame: 5 months

    digital testing of pelvic induration by physician (scale: high, moderate, none) compared to baseline

  2. Number of patients showing improvement (reduction in questionnaire sum) in symptoms as assed by subjective questionnaire

    Time frame: 5 months, 12 months

    subjective evaluation by validated questionnaire (Genitourinary Pain Index for Women, sum scale 0-45, the lower the value the lower the symptoms) compared to baseline

  3. Number of patients reporting pain during laser treatment

    Time frame: 3 months

    VAS (visual analogue scale, 0-10 where 0 is none and 10 the worst) pain score during laser treatment

  4. Number of patients showing urethral infections before and after treatment

    Time frame: 5 months

    Analysis of urethral infections before and after treatment using urine dipstick test (positive/negative)

  5. Number of patients reporting satisfaction with treatment outcome

    Time frame: 5 months, 12 months

    subjective evaluation of improvement (patient global index fo improvement, 7-item scale from "very much worse" to "very much better"), cure/improvement defined as response "much better" or "very much better"

Other outcomes

  1. Number of patients reprting good tolerability ("good" or "very good") of vulvar creams in combination with laser treatment

    Time frame: 5 months

    Patient satisfaction (5-item scale from "not at all" to "very good") on the use of vulvar creams

Study contacts

Contact information is provided by the study sponsor or research team.

Volker Viereck, Prof. Dr.

CONTACT

[email protected]

+41 52 511 20 20

Sponsors and collaborators

Lead sponsor

Prof. Dr. Volker Viereck

Other

Registry information

Official study 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

Acronym: UPS-IUL

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Apr 25, 2022
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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