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New treatment option for Pelvic Pain Syndrome
Official title FotonaSmooth Erbium:YAG Laser for the Treatment of Urethral Pain Syndrome in Women
ClinicalTrials.gov ID: NCT05344716
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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
You likely can't join if
- 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...
- Pre-existing bladder or urethra pathology
- Interstitial Cystitis
See the full eligibility 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Frauenfeld, Thurgau, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Frauenfeld, Thurgau, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.