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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Pelvic Pain Syndrome

Intervention / Treatment
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* Device: Laser


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laser<br>Intraurethral and vaginal laser treatment | Device: Laser<br>* Intraurethral and vaginal laser treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients showing improvement in symptoms due to laser treatment | 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 | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients showing improvement (reduction) in induration after treatment | digital testing of pelvic induration by physician (scale: high, moderate, none) compared to baseline | 5 months | 
| Number of patients showing improvement (reduction in questionnaire sum) in symptoms as assed by subjective questionnaire | 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 | 5 months, 12 months | 
| Number of patients reporting pain during laser treatment | VAS (visual analogue scale, 0-10 where 0 is none and 10 the worst) pain score during laser treatment | 3 months | 
| Number of patients showing urethral infections before and after treatment | Analysis of urethral infections before and after treatment using urine dipstick test (positive/negative) | 5 months | 
| Number of patients reporting satisfaction with treatment outcome | 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 | 5 months, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laser, urethra, pain, intraurethral, erbium, fotona