NCT04348994

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2015

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 14, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 16, 2020

Completed
Last Updated

April 17, 2020

Status Verified

April 1, 2020

Enrollment Period

3.5 years

First QC Date

April 14, 2020

Last Update Submit

April 15, 2020

Conditions

Stress Urinary Incontinence

Keywords

stress urinary incontinencenon-ablative Er:YAG laser

Outcome Measures

Primary Outcomes (2)

  • Assessment of ICIQ-UI SF scores

    Change in mean test scores range = 0 - 21; low score = mild symptoms, high score = significant impact on quality of life.

    Baseline, 3, 6, 12, 18, 24, 30 and 36 months

  • Assessment of 1 hour pad weight test

    The change in standardised 1 hour pad weight test from baseline to 36 months following treatment schedule.

    Baseline, 3, 6, 12, 18, 24, 30 and 36 months

Secondary Outcomes (2)

  • Change in 24 hour pad weight test

    Baseline, 3, 6, 12, 18, 24, 30 and 36 months

  • Change in leakage frequency as assessed by 3 day voiding diary

    Baseline, 3, 6, 12, 18, 24, 30 and 36 months

Study Arms (1)

Laser therapy

EXPERIMENTAL

Non-ablative thermal-only Er:YAG laser treatment using IncontiLase® protocol.

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

Interventions

Non-ablative thermal-only Er:YAG laser therapyDEVICE

Each patient will receive 3 sessions of Er:YAG laser treatment for SUI (IncontiLase®). Single-session treatments will be offered to patients after 18, 24 and 30 months following the initial three sessions.

Also known as: IncontiLase®
Laser therapy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Gaspar A, Koron N, Silva J, Brandi H. Vaginal erbium laser for treatment of stress urinary incontinence: optimization of treatment regimen for a sustained long-term effect. Lasers Med Sci. 2022 Jun;37(4):2157-2164. doi: 10.1007/s10103-021-03474-z. Epub 2022 Jan 24.

    PMID: 35067817DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 14, 2020

First Posted

April 16, 2020

Study Start

March 1, 2015

Primary Completion

September 1, 2018

Study Completion

December 31, 2018

Last Updated

April 17, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share