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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laser | Experimental | Intraurethral and vaginal laser treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laser | Device | Intraurethral and vaginal laser treatment |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients reprting good tolerability ("good" or "very good") of vulvar creams in combination with laser treatment | Patient satisfaction (5-item scale from "not at all" to "very good") on the use of vulvar creams | 5 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Volker Viereck, Prof. Dr. | Contact | +41 52 511 20 20 | volker.viereck@blasenzentrum-der-frau.ch |
| Name | Affiliation | Role |
|---|---|---|
| Volker Viereck, Prof. Dr. | Blasenzentrum der Frau AG | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Blasenzentrum der Frau AG | Recruiting | Frauenfeld | Thurgau | 8500 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29667744 | Background | 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. | |
| 28210823 | Background | 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. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007834 | Lasers |
| ID | Term |
|---|---|
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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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 |
| 33170523 | Background | 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/nau.24551. Epub 2020 Nov 10. |
| 31828400 | Background | 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. |
| 12402379 | Background | 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. |
| 17425813 | Background | 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. |
| 25763800 | Background | 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. |
| 26029987 | Background | 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. |
| 26861984 | Background | Fistonic N, Fistonic I, Gustek SF, Turina IS, Marton I, Vizintin Z, Kazic M, Hreljac I, Perhavec T, Lukac M. Minimally invasive, non-ablative Er:YAG laser treatment of stress urinary incontinence in women--a pilot study. Lasers Med Sci. 2016 May;31(4):635-43. doi: 10.1007/s10103-016-1884-0. Epub 2016 Feb 9. |
| 29360142 | Background | Fistonic I, Fistonic N. Baseline ICIQ-UI score, body mass index, age, average birth weight, and perineometry duration as promising predictors of the short-term efficacy of Er:YAG laser treatment in stress urinary incontinent women: A prospective cohort study. Lasers Surg Med. 2018 Jan 23. doi: 10.1002/lsm.22789. Online ahead of print. |
| 29436235 | Background | Gambacciani M, Levancini M, Russo E, Vacca L, Simoncini T, Cervigni M. Long-term effects of vaginal erbium laser in the treatment of genitourinary syndrome of menopause. Climacteric. 2018 Apr;21(2):148-152. doi: 10.1080/13697137.2018.1436538. Epub 2018 Feb 13. |
| 29604548 | Background | Blaganje M, Scepanovic D, Zgur L, Verdenik I, Pajk F, Lukanovic A. Non-ablative Er:YAG laser therapy effect on stress urinary incontinence related to quality of life and sexual function: A randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2018 May;224:153-158. doi: 10.1016/j.ejogrb.2018.03.038. Epub 2018 Mar 22. |