Status:
RECRUITING
FotonaSmooth Erbium:YAG Laser for the Treatment of Urethral Pain Syndrome in Women
Lead Sponsor:
Prof. Dr. Volker Viereck
Conditions:
Pelvic Pain Syndrome
Eligibility:
FEMALE
18+ years
Phase:
NA
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 i...
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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05344716
Start Date
September 1 2022
End Date
December 1 2026
Last Update
October 4 2023
Active Locations (1)
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1
Cantonal Hospital Frauenfeld
Frauenfeld, Thurgau, Switzerland, 8501