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

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ClinicalTrials.gov Identifier: NCT05344716
Recruitment Status : Recruiting
First Posted : April 25, 2022
Last Update Posted : September 23, 2022
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Volker Viereck, Cantonal Hospital, Frauenfeld

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.

Condition or disease Intervention/treatment Phase
Pelvic Pain Syndrome Device: Laser Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 1, 2022
Estimated Primary Completion Date : December 2026
Estimated Study Completion Date : December 2026

Resource links provided by the National Library of Medicine

Drug Information available for: Erbium

Arm Intervention/treatment
Experimental: Laser
Intraurethral and vaginal laser treatment
Device: Laser
Intraurethral and vaginal laser treatment




Primary Outcome Measures :
  1. Number of patients showing improvement in symptoms due to 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


Secondary Outcome Measures :
  1. Number of patients showing improvement (reduction) in induration after treatment [ Time Frame: 5 months ]
    digital testing of pelvic induration by physician (scale: high, moderate, none) compared to baseline

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

  3. Number of patients reporting pain during laser treatment [ Time Frame: 3 months ]
    VAS (visual analogue scale, 0-10 where 0 is none and 10 the worst) pain score during laser treatment

  4. Number of patients showing urethral infections before and after treatment [ Time Frame: 5 months ]
    Analysis of urethral infections before and after treatment using urine dipstick test (positive/negative)

  5. Number of patients reporting satisfaction with treatment outcome [ 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"


Other Outcome Measures:
  1. Number of patients reprting good tolerability ("good" or "very good") of vulvar creams in combination with laser treatment [ Time Frame: 5 months ]
    Patient satisfaction (5-item scale from "not at all" to "very good") on the use of vulvar creams



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05344716


Contacts
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Contact: Volker Viereck, Prof. Dr. +41 52 723 70 60 volker.viereck@stgag.ch

Locations
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Switzerland
Cantonal Hospital Frauenfeld Recruiting
Frauenfeld, Thurgau, Switzerland, 8501
Contact: Volker Viereck, MD       volker.viereck@stgag.ch   
Contact: Marianne Gamper, PhD       marianne.gamper@stgag.ch   
Sponsors and Collaborators
Prof. Dr. Volker Viereck
Investigators
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Principal Investigator: Volker Viereck, Prof. Dr. Cantonal Hospital, Frauenfeld
Publications:

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Responsible Party: Prof. Dr. Volker Viereck, Prof. Dr. med., Cantonal Hospital, Frauenfeld
ClinicalTrials.gov Identifier: NCT05344716    
Other Study ID Numbers: Pilot UPS-IUL
First Posted: April 25, 2022    Key Record Dates
Last Update Posted: September 23, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Dr. Volker Viereck, Cantonal Hospital, Frauenfeld:
urethra
pain
laser
intraurethral
erbium
fotona
Additional relevant MeSH terms:
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Syndrome
Pelvic Pain
Somatoform Disorders
Disease
Pathologic Processes
Mental Disorders
Pain
Neurologic Manifestations