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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Laser
  Intraurethral and vaginal laser treatment

Первичные конечные точки

• Number of patients showing improvement in symptoms due to laser treatment [Срок оценки: 5 months]

Вторичные конечные точки (5)

• Number of patients showing improvement (reduction) in induration after treatment [Срок оценки: 5 months]
• Number of patients showing improvement (reduction in questionnaire sum) in symptoms as assed by subjective questionnaire [Срок оценки: 5 months, 12 months]
• Number of patients reporting pain during laser treatment [Срок оценки: 3 months]
• Number of patients showing urethral infections before and after treatment [Срок оценки: 5 months]
• Number of patients reporting satisfaction with treatment outcome [Срок оценки: 5 months, 12 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Швейцария · 1 центр

• Blasenzentrum der Frau AG — Frauenfeld

Публикации

• Gaspar A, Maestri S, Silva J, Brandi H, Luque D, Koron N, Vizintin Z. Intraurethral Erbium:YAG laser for the management of urinary symptoms of genitourinary syndrome of menopause: A pilot study. Lasers Surg Med. 2018 Oct;50(8):802-807. doi: 10.1002/lsm.22826. Epub 2018 Apr 18. PMID 29667744
• Gaspar A, Brandi H. Non-ablative erbium YAG laser for the treatment of type III stress urinary incontinence (intrinsic sphincter deficiency). Lasers Med Sci. 2017 Apr;32(3):685-691. doi: 10.1007/s10103-017-2170-5. Epub 2017 Feb 16. PMID 28210823
• Gaspar A, Silva J, Silva G, Anchelerguez R, Prats J, Sagaz A, Rovere E, Alastra M, Pino J, Jauregui A, Farrugia M, Villaroel F, Guareschi J, Vega M, Biasiori E, Moyano E, La Rosa A, Hreljac I, Vizintin Z. Nonablative transurethral Erbium:YAG laser treatment for chronic prostatitis/chronic pelvic pain syndrome: A prospective comparative study. Neurourol Urodyn. 2021 Jan;40(1):278-285. doi: 10.1002/ PMID 33170523
• Kuszka A, Gamper M, Walser C, Kociszewski J, Viereck V. Erbium:YAG laser treatment of female stress urinary incontinence: midterm data. Int Urogynecol J. 2020 Sep;31(9):1859-1866. doi: 10.1007/s00192-019-04148-9. Epub 2019 Dec 11. PMID 31828400
• Yoon SM, Jung JK, Lee SB, Lee T. Treatment of female urethral syndrome refractory to antibiotics. Yonsei Med J. 2002 Oct;43(5):644-51. doi: 10.3349/ymj.2002.43.5.644. PMID 12402379
• Kaur H, Arunkalaivanan AS. Urethral pain syndrome and its management. Obstet Gynecol Surv. 2007 May;62(5):348-51; quiz 353-4. doi: 10.1097/01.ogx.0000261645.12099.2a. PMID 17425813
• Gambacciani M, Levancini M. Short-term effect of vaginal erbium laser on the genitourinary syndrome of menopause. Minerva Ginecol. 2015 Apr;67(2):97-102. PMID 25763800
• Gambacciani M, Levancini M, Cervigni M. Vaginal erbium laser: the second-generation thermotherapy for the genitourinary syndrome of menopause. Climacteric. 2015 Oct;18(5):757-63. doi: 10.3109/13697137.2015.1045485. PMID 26029987

Идентификаторы

NCT: NCT05344716 · Pilot UPS-IUL

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗