Status:
COMPLETED
Long-term Effectiveness of Non-ablative Er: YAG Laser for Treatment of Stress Urinary Incontinence (SUI)
Lead Sponsor:
Adrian Gaspar
Collaborating Sponsors:
Fotona d.o.o.
Conditions:
Stress Urinary Incontinence
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Study is designed to assess the long-term clinical effects and safety profile of non-ablative Er:YAG (IncontiLase®) laser treatment, the durability of the results and the optimal treatment regimen for...
Detailed Description
All patients with urodynamically proven SUI, who have failed/declined conservative therapies will be informed about the study. They will be invited to attend a screening/baseline visit. At this visit...
Eligibility Criteria
Inclusion
- Adult Female, 18 years of age or older
- Clinical and urodynamic study (UDS) diagnosis of Stress Urinary Incontinence
- No significant improvement in urinary incontinence from at least one previous conservative treatment, such as pelvic floor muscle training
Exclusion
- Pre-existing bladder pathology including prior radiation treatment
- Pregnancy
- BMI\>35
- Radical pelvic surgery or previous incontinence surgery
- Urinary tract infection or other active infections of urinary tract or bladder
- SUI III (VLPP \> 60 cm H2O)
- Any form of pelvic organ prolapse (POP) stage 2 or greater, according to POP-Q
- Diagnosis of urge incontinence
- Diagnosis of collagen disorders eg.benign joint hypermobility / Elhers-Danlos / Marfans etc.
- Incomplete bladder emptying
- Vesicovaginal fistula
- Faecal incontinence
- Unwillingness or inability to complete follow-up schedule
- Unwillingness or inability to give Informed Consent
- Failure to comply with diary requirements during extended baseline period
Key Trial Info
Start Date :
March 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2018
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT04348994
Start Date
March 1 2015
End Date
December 31 2018
Last Update
April 17 2020
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.