Pelvic Pain Syndrome
Conditions
Keywords
urethra, pain, laser, intraurethral, erbium, fotona
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.
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 infection by fastidious bacteria leading to chronic inflammation and pain may also cause UPS. Due to the unclear aetiology, the optimal treatment is challenging. It is therefore essential to find new and effective treatment options for patients suffering from UPS. Over the last few years, the use of lasers has become more popular to treat gynaecological and urogynecological conditions including stress urinary incontinence (SUI), genitourinary syndrome of menopause (GSM), vaginal prolapse and other conditions. In several trials, vaginal laser therapy has been shown to have a very good effect on SUI and GSM. Very few publications are available on the use of intraurethral laser therapy for the treatment of SUI and GSM with promising results. This is the first study to test the effect of intraurethral and vaginal laser therapy for the treatment of UPS. The hypothesis is that symptoms can be relieved in patients with UPS i.e. a reduction of urethral pressure pain upon palpation can be achieved.
Interventions
DEVICELaser
Intraurethral and vaginal laser treatment
Sponsors
Prof. Dr. Volker Viereck
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients showing improvement in symptoms due to laser treatment | 5 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients showing improvement (reduction) in induration after treatment | 5 months | digital testing of pelvic induration by physician (scale: high, moderate, none) compared to baseline |
| Number of patients showing improvement (reduction in questionnaire sum) in symptoms as assed by subjective questionnaire | 5 months, 12 months | 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 |
| Number of patients reporting pain during laser treatment | 3 months | VAS (visual analogue scale, 0-10 where 0 is none and 10 the worst) pain score during laser treatment |
| Number of patients showing urethral infections before and after treatment | 5 months | Analysis of urethral infections before and after treatment using urine dipstick test (positive/negative) |
| Number of patients reporting satisfaction with treatment outcome | 5 months, 12 months | subjective evaluation of improvement (patient global index fo improvement, 7-item scale from "very much worse" to "very much better"), cure/improvement defined as response "much better" or "very much better" |
Countries
Switzerland
Contacts
CONTACTVolker Viereck, Prof. Dr.
PRINCIPAL_INVESTIGATORVolker Viereck, Prof. Dr.
Blasenzentrum der Frau AG
Outcome results
None listed