Blasenzentrum der Frau AG
Frauenfeld, Thurgau, 8500, Switzerland
Location status: Recruiting
Location contact
Marianne Gamper, PhD
CONTACT
Volker Viereck, MD
CONTACT
NCT Number: NCT05344716
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.
Interested in participating?
Request Info18 year and older
Female
Interventional
Not applicable
Frauenfeld, Thurgau, 8500, Switzerland
Location status: Recruiting
Marianne Gamper, PhD
CONTACT
Volker Viereck, MD
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intraurethral and vaginal 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
Time frame: 5 months
digital testing of pelvic induration by physician (scale: high, moderate, none) compared to baseline
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
Time frame: 3 months
VAS (visual analogue scale, 0-10 where 0 is none and 10 the worst) pain score during laser treatment
Time frame: 5 months
Analysis of urethral infections before and after treatment using urine dipstick test (positive/negative)
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"
Time frame: 5 months
Patient satisfaction (5-item scale from "not at all" to "very good") on the use of vulvar creams
Contact information is provided by the study sponsor or research team.
Prof. Dr. Volker Viereck
Other
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
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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