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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Intraurethral and vaginal laser treatment
Blasenzentrum der Frau AG
Frauenfeld, Thurgau, Switzerland
RECRUITINGNumber 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
Time frame: 5 months
Number of patients showing improvement (reduction) in induration after treatment
digital testing of pelvic induration by physician (scale: high, moderate, none) compared to baseline
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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"
Time frame: 5 months, 12 months
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