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

ConditionPelvic Pain Syndrome

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18+

SponsorProf. Dr. Volker Viereck

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.)

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

Laser
Device
Intraurethral and vaginal laser treatment

Treatment groups

30 Participants

are divided into 1 treatment group

Group A: LaserExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

Time frame

5 months

Secondary outcomes

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

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

Time frame

5 months

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

Time frame

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

Time frame

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)

Time frame

5 months

Other outcomes

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

Time frame

5 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Prof. Dr. Volker Viereck

Lead sponsor

Cantonal Hospital, Frauenfeld

Sponsor institution

Source ClinicalTrials.gov

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