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FotonaSmooth Erbium:YAG Laser for the Treatment of Urethral Pain Syndrome in Women (UPS-IUL)

Primary Purpose

Pelvic Pain Syndrome

Status

Recruiting

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

Laser

About this trial

This is an interventional treatment trial for Pelvic Pain Syndrome focused on measuring urethra, pain, laser, intraurethral, erbium, fotona

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Cantonal Hospital FrauenfeldRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Laser

Arm Description

Intraurethral and vaginal laser treatment

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of patients showing improvement (reduction) in induration after treatment

digital testing of pelvic induration by physician (scale: high, moderate, none) compared to baseline

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

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

Number of patients showing urethral infections before and after treatment

Analysis of urethral infections before and after treatment using urine dipstick test (positive/negative)

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"

Full Information

NCT ID

NCT05344716

First Posted

March 30, 2022

Last Updated

October 3, 2023

Sponsor

Prof. Dr. Volker Viereck

1. Study Identification

Unique Protocol Identification Number

NCT05344716

Brief Title

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

Acronym

UPS-IUL

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 1, 2022 (Actual)

Primary Completion Date

December 2026 (Anticipated)

Study Completion Date

December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Prof. Dr. Volker Viereck

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pelvic Pain Syndrome

Keywords

urethra, pain, laser, intraurethral, erbium, fotona

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Laser

Arm Type

Experimental

Arm Description

Intraurethral and vaginal laser treatment

Intervention Type

Device

Intervention Name(s)

Laser

Intervention Description

Intraurethral and vaginal laser treatment

Primary Outcome Measure Information:

Title

Number of patients showing improvement in symptoms due to laser treatment

Description

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

Secondary Outcome Measure Information:

Title

Number of patients showing improvement (reduction) in induration after treatment

Description

digital testing of pelvic induration by physician (scale: high, moderate, none) compared to baseline

Time Frame

5 months

Title

Number of patients showing improvement (reduction in questionnaire sum) in symptoms as assed by subjective questionnaire

Description

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

Title

Number of patients reporting pain during laser treatment

Description

VAS (visual analogue scale, 0-10 where 0 is none and 10 the worst) pain score during laser treatment

Time Frame

3 months

Title

Number of patients showing urethral infections before and after treatment

Description

Analysis of urethral infections before and after treatment using urine dipstick test (positive/negative)

Time Frame

5 months

Title

Number of patients reporting satisfaction with treatment outcome

Description

Time Frame

5 months, 12 months

Other Pre-specified Outcome Measures:

Title

Number of patients reprting good tolerability ("good" or "very good") of vulvar creams in combination with laser treatment

Description

Patient satisfaction (5-item scale from "not at all" to "very good") on the use of vulvar creams

Time Frame

5 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Volker Viereck, Prof. Dr.

Phone

+41 52 723 70 60

volker.viereck@stgag.ch

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Volker Viereck, Prof. Dr.

Organizational Affiliation

Cantonal Hospital, Frauenfeld

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cantonal Hospital Frauenfeld

City

Frauenfeld

State/Province

Thurgau

ZIP/Postal Code

8501

Country

Switzerland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Volker Viereck, MD

volker.viereck@stgag.ch

First Name & Middle Initial & Last Name & Degree

Marianne Gamper, PhD

marianne.gamper@stgag.ch

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

29667744

Citation

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.

Results Reference

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PubMed Identifier

28210823

Citation

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.

Results Reference

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PubMed Identifier

33170523

Citation

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.

Results Reference

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PubMed Identifier

31828400

Citation

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.

Results Reference

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PubMed Identifier

12402379

Citation

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.

Results Reference

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PubMed Identifier

17425813

Citation

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.

Results Reference

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PubMed Identifier

25763800

Citation

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.

Results Reference

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PubMed Identifier

26029987

Citation

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.

Results Reference

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PubMed Identifier

26861984

Citation

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.

Results Reference

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PubMed Identifier

29360142

Citation

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.

Results Reference

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PubMed Identifier

29436235

Citation

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.

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PubMed Identifier

29604548

Citation

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.

Results Reference

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

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