NCT05344716 FotonaSmooth Erbium:YAG Laser for the Treatment of Urethral Pain Syndrome in Women
| NCT ID | NCT05344716 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Prof. Dr. Volker Viereck |
| Condition | Pelvic Pain Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2022-09-01 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2022-09-01 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Volker Viereck, Prof. Dr.
PRINCIPAL INVESTIGATOR
Blasenzentrum der Frau AG
Frequently Asked Questions
Who can join the NCT05344716 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Pelvic Pain Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05344716 currently recruiting?
Yes, NCT05344716 is actively recruiting participants. Contact the research team at volker.viereck@blasenzentrum-der-frau.ch for enrollment information.
Where is the NCT05344716 trial being conducted?
This trial is being conducted at Frauenfeld, Switzerland.
Who is sponsoring the NCT05344716 clinical trial?
NCT05344716 is sponsored by Prof. Dr. Volker Viereck. The principal investigator is Volker Viereck, Prof. Dr. at Blasenzentrum der Frau AG. The trial plans to enroll 30 participants.