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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of patients showing improvement in symptoms due to laser treatment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Number of patients showing improvement in symptoms due to laser treatment
时间窗: 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
次要结局
- Number of patients showing improvement (reduction in questionnaire sum) in symptoms as assed by subjective questionnaire(5 months, 12 months)
- Number of patients reporting satisfaction with treatment outcome(5 months, 12 months)
- Number of patients showing urethral infections before and after treatment(5 months)
- Number of patients showing improvement (reduction) in induration after treatment(5 months)
- Number of patients reporting pain during laser treatment(3 months)
研究者
Prof. Dr. Volker Viereck
Prof. Dr. med.
Cantonal Hospital, Frauenfeld