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RecruitingNot ApplicableNCT05344716

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

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

Sponsor

Prof. Dr. Volker Viereck

Enrollment

30 participants

Start Date

Sep 1, 2022

Study Type

INTERVENTIONAL

Conditions

Pelvic Pain Syndrome

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria5

  • 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 Criteria12

  • 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
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Interventions

DEVICELaser

Intraurethral and vaginal laser treatment

Locations(1)

Blasenzentrum der Frau AG

Frauenfeld, Thurgau, Switzerland

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