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

Sponsor

Prof. Dr. Volker Viereck (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05344716

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Pain Syndrome	Device: Laser	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

12 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

Anticipated Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Laser

Intraurethral and vaginal laser treatment

Device: Laser

Intraurethral and vaginal laser treatment

Outcome Measures

Primary Outcome Measures

Number of patients showing improvement in symptoms due to laser treatment [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
Number of patients reporting satisfaction with treatment outcome [5 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"

Secondary Outcome Measures

Number of patients showing improvement (reduction) in induration after treatment [5 months]
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 [5 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
Number of patients reporting pain during laser treatment [3 months]
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 [5 months]
Analysis of urethral infections before and after treatment using urine dipstick test (positive/negative)

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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