Long-term Effectiveness of Non-ablative Er: YAG Laser for Treatment of Stress Urinary Incontinence (SUI)

A

Adrian Gaspar

Status

Completed

Conditions

Stress Urinary Incontinence

Treatments

Device: Non-ablative thermal-only Er:YAG laser therapy

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT04348994
SUI/01/2015

Details and patient eligibility

About

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 mild-to-severe stages of genuine female stress urinary incontinence (SUI).

Full 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, they will be asked to perform a standardised 1 hour pad test. Their medical history will be checked and they will undergo a clinical and vaginal examination, pregnancy test and dip stick urinalysis. If their 1 hour pad weight is >2g and they meet all other inclusion / exclusion criteria, they will be eligible for inclusion. They will receive detailed instructions for performing a 24 hour pad test, and will be asked to keep a 3 day voiding diary. They will be given the International Consultation on Incontinence Questionnaire Short Form (ICIQ-UI SF). Patients will then undergo 3 outpatient treatment visits. The timing of visits will be approximately 1 month apart. At each of their 3 outpatient appointments, they will be asked about any deleterious effects since their last appointment. Patients will receive 3 treatments in total. Patients will be invited to attend a follow-up visits 3, 6, 12 and 18 months after the 3rd treatment and asked to complete the 1 hour pad test, 24 hour pad test, 3 day voiding diary and ICIQ-SF questionnaire. At the 18-, 24- and 30-month follow up, they will be given an option to receive additional single session of non-ablative Er:YAG laser treatment. At each visit, and during additional visit after 36 months, they will be asked to complete all of the tests (1 hour pad test, 24 h hour pad test, 3 day voiding diary and ICIQ-UI SF).

Enrollment

43 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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 criteria

  • 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

Trial design

43 participants in 1 patient group

Laser therapy
Experimental group
Description:
Non-ablative thermal-only Er:YAG laser treatment using IncontiLase® protocol.
Treatment:
Device: Non-ablative thermal-only Er:YAG laser therapy

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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