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Intraurethral/Intravaginal 2940 nm Erbium Laser Treatment For Stress Urinary Incontinence

Primary Purpose

Stress Urinary Incontinence

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Sham Fotona SP Dynamis
Intravaginal Fotona SP Dynamis
Intraurethral Fotona SP Dynamis
Sponsored by
Fotona d.o.o.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Female between 18 and 80 years
  • SUI or MUI with predominantly stress symptoms for more than 6 months
  • Has failed 2 previous non-invasive therapies for three (3) months each (e.g. behavioural modification, electrical stimulation, pelvic muscle exercise, biofeedback, and/or drug therapy)
  • Confirmed SUI through cough stress test or urodynamics
  • Has at least one incontinence episode per 24 hour period measured over three days
  • Valsalva leak-point pressure (VLPP) ≤100 cm H2O
  • Has a baseline 24h pad weight test ≥ 10 gm
  • Has maximum cystometric capacity ≥250 mL
  • No pelvic surgery within last 6 months (including prolapse repair, subjects who have residual or recurrent SUI following colposuspension or a sling procedure may be included in the study if the procedure was conducted at least 6 months prior to screening /baseline visit)
  • Willing to give informed consent and complete the follow up schedule

Exclusion Criteria:

  • Active urinary tract or vaginal infection or other active infections of urinary tract or bladder (urethritis, cystitis or vaginitis)
  • Has had three (3) or more cultured-proven bacterial urinary tract infection (UTI) in the last 12 months
  • Clinical diagnosis of urge incontinence or urge predominant mixed incontinence
  • Has detrusor overactivity on urodynamics
  • postvoiding residual (PVR) > 100 ml
  • Has had previous urethral surgery (i.e. fistula or diverticula)
  • Grade 2 or higher Pelvic organ prolapse (POP) or Pelvic organ prolapse grade > 2 as defined by POP-Q and symptomatic
  • Suffers from known polyuria (>3l/24h)
  • Has a BMI ≤35 kg/m2
  • Has unevaluated hematuria
  • Has a neurogenic bladder
  • Evidence of dysplasia in a Pap smear (done in the last 24 months)
  • Tumours of the Urinary tract
  • Previous radiation or brachytherapy to treat pelvic cancer
  • Has uncontrolled diabetes
  • Has active herpes genitalis
  • Pregnancy, lactating, or not practicing adequate contraception and/or planning to get pregnant in the next 12 months
  • Had a vaginal delivery within 6 months prior to the Screening/Baseline Visit
  • Is currently participating in any other clinical trial, or has participated in another clinical trial within 3 months prior to the Screening/Baseline Visit

Sites / Locations

  • University Urology AssociatesRecruiting
  • Exgogenia, Institute of Anti-Aging and Regenerative MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Active Comparator

Experimental

Arm Label

Sham Treatment

Intravaginal Treatment

Intravaginal and intraurethral Treatment

Arm Description

Sham Fotona SP Dynamis Treatment - minimum energy delivered through sham handpiece.

Intravaginal Fotona SP Dynamis Treatment - energy delivered intravaginally.

Intravaginal and intraurethral Fotona SP Dynamis Treatment Intravaginal Treatment - energy delivered intravaginally and intraurethrally.

Outcomes

Primary Outcome Measures

Tolerability of the 2940nm Er:YAG laser technique by VAS pain scale
The tolerability of intra-urethral/intravaginal Er:YAG laser treatment by VAS pain scale during procedure and by monitoring the use of pain relieving medication post treatment. The Visual Analog Scale for Pain (VAS) is a unidimensional measure of pain intensity, which has been widely used in diverse adult populations.
The Safety of intra-urethral/intravaginal Er:YAG laser procedure by recording the incidence and severity of complications
The Safety of intra-urethral/intravaginal Er:YAG laser procedure for the treatment of stress urinary incontinence in women, as assessed by recording the incidence and severity of complications
The Safety of intra-urethral/intravaginal Er:YAG laser procedure by recording the incidence of device related adverse events
The Safety of intra-urethral/intravaginal Er:YAG laser procedure for the treatment of stress urinary incontinence in women, as assessed by recording the incidence of device related adverse events
The Safety of intra-urethral/intravaginal Er:YAG laser procedure by measure uroflow and post void residual (PVR)
The Safety of intra-urethral/intravaginal Er:YAG laser procedure for the treatment of stress urinary incontinence in women, as assessed by measure uroflow and post void residual (PVR) 6 months after the 2ed treatment
The Safety of intra-urethral/intravaginal Er:YAG laser procedure by Questionnaire for voiding symptoms (based on IPSS)
The Safety of intra-urethral/intravaginal Er:YAG laser procedure for the treatment of stress urinary incontinence in women, as assessed by questionnaire for voiding symptoms (based on IPSS)

Secondary Outcome Measures

The effectiveness of the intravaginal and combination of intraurethral/intravaginal laser treatments by recording 3-day voiding diary
The efficacy of intra-urethral/intravaginal Er:YAG laser procedure for the treatment of stress urinary incontinence in women by recording of improvement in daily number of incontinence episodes via 3-day voiding diary The 3-day voiding diary is a log used to record number of pads used, incontinence episodes, the activity in which the subject was engaged when the incontinence occurred, and micturitions.
The effectiveness of the intravaginal and combination of intraurethral/intravaginal laser treatments by 24-Hour Pad-Weight Test
The 24-Hour Pad-Weight Test will be used to reflect everyday incontinence. This test, standardized by the International Continence Society, correlates well with UI symptoms, and has good reproducibility.
The effectiveness of the intravaginal and combination of intraurethral/intravaginal laser treatments by ICIQ-UI short form questionnaire
The efficacy of intra-urethral/intravaginal Er:YAG laser procedure for the treatment of stress urinary incontinence in women reduction in SUI as measured by ICIQ-UI short form questionnaire. The ICIQ-UI Short Form Questionnaire provides a brief and robust measure to assess the impact of symptoms of incontinence on quality of life and outcome of treatment.
The effectiveness of the intravaginal and combination of intraurethral/intravaginal laser treatments by recording patient global impression of improvement (PGI-I)
• The efficacy of intra-urethral/intravaginal Er:YAG laser procedure for the treatment of stress urinary incontinence in women by recording patient global impression of improvement (PGI-I). The Patient Global Impression of Improvement (PGI-I) Questionnaire is a global index that may be used to rate the response of a condition to a therapy (transition scale).

Full Information

First Posted
September 10, 2018
Last Updated
February 4, 2020
Sponsor
Fotona d.o.o.
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1. Study Identification

Unique Protocol Identification Number
NCT03676894
Brief Title
Intraurethral/Intravaginal 2940 nm Erbium Laser Treatment For Stress Urinary Incontinence
Official Title
Pilot Single-masked, Randomized, 3-arm Parallel Study Assessing the Tolerability, Safety and Efficacy of Intraurethral/Intravaginal 2940 nm Er:YAG Laser Treatment For Stress Urinary Incontinence
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 4, 2018 (Actual)
Primary Completion Date
December 4, 2021 (Anticipated)
Study Completion Date
December 4, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fotona d.o.o.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Primary objective is to assess the tolerability and safety of the intraurethral 2940nm Er:YAG laser technique in combination with intravaginal 2940nm Er:YAG laser method for the treatment of stress urinary incontinence.
Detailed Description
This study is a prospective, randomized, 3-arm parallel pilot study. Study subjects will be women currently experiencing female stress urinary incontinence (SUI) and stress-predominant mixed urinary incontinence (SMUI) with a degree of intrinsic sphincter deficiency for a minimum duration of 6 months prior to enrolment. Diagnosis of SUI with a degree of intrinsic sphincter deficiency will be performed using urodynamic and clinical assessment. Subjects will undergo sham, intravaginal, and the combination of intravaginal and intraurethral treatment with the 2940 nm Er:yttrium aluminum garnet Er:YAG laser at two time points, 4 weeks apart. Primary objective is to assess the tolerability and safety of the intraurethral 2940nm Er:YAG laser technique in combination with intravaginal 2940nm Er:YAG laser method for the treatment of stress urinary incontinence through 6 months follow-up and extend to 12 months follow-up. Secondary objective is to assess the effectiveness of the intravaginal and combination of intraurethral/intravaginal laser treatments using subjective and objective measures, as well as improvement in quality of life through 6 months follow-up and extend to 12 months follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, randomized, 3-arm parallel pilot study
Masking
Participant
Allocation
Randomized
Enrollment
55 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sham Treatment
Arm Type
Sham Comparator
Arm Description
Sham Fotona SP Dynamis Treatment - minimum energy delivered through sham handpiece.
Arm Title
Intravaginal Treatment
Arm Type
Active Comparator
Arm Description
Intravaginal Fotona SP Dynamis Treatment - energy delivered intravaginally.
Arm Title
Intravaginal and intraurethral Treatment
Arm Type
Experimental
Arm Description
Intravaginal and intraurethral Fotona SP Dynamis Treatment Intravaginal Treatment - energy delivered intravaginally and intraurethrally.
Intervention Type
Device
Intervention Name(s)
Sham Fotona SP Dynamis
Intervention Description
Female patients with SUI will be treated with non-ablative Er:YAG laser with Fotona SP Dynamis with sham handpiece.
Intervention Type
Device
Intervention Name(s)
Intravaginal Fotona SP Dynamis
Intervention Description
Female patients with SUI will be treated intravaginaly with non-ablative Er:YAG laser with Fotona SP Dynamis
Intervention Type
Device
Intervention Name(s)
Intraurethral Fotona SP Dynamis
Intervention Description
Female patients with SUI will be treated intraurethraly with non-ablative Er:YAG laser with Fotona SP Dynamis
Primary Outcome Measure Information:
Title
Tolerability of the 2940nm Er:YAG laser technique by VAS pain scale
Description
The tolerability of intra-urethral/intravaginal Er:YAG laser treatment by VAS pain scale during procedure and by monitoring the use of pain relieving medication post treatment. The Visual Analog Scale for Pain (VAS) is a unidimensional measure of pain intensity, which has been widely used in diverse adult populations.
Time Frame
18 months
Title
The Safety of intra-urethral/intravaginal Er:YAG laser procedure by recording the incidence and severity of complications
Description
The Safety of intra-urethral/intravaginal Er:YAG laser procedure for the treatment of stress urinary incontinence in women, as assessed by recording the incidence and severity of complications
Time Frame
18 months
Title
The Safety of intra-urethral/intravaginal Er:YAG laser procedure by recording the incidence of device related adverse events
Description
The Safety of intra-urethral/intravaginal Er:YAG laser procedure for the treatment of stress urinary incontinence in women, as assessed by recording the incidence of device related adverse events
Time Frame
18 months
Title
The Safety of intra-urethral/intravaginal Er:YAG laser procedure by measure uroflow and post void residual (PVR)
Description
The Safety of intra-urethral/intravaginal Er:YAG laser procedure for the treatment of stress urinary incontinence in women, as assessed by measure uroflow and post void residual (PVR) 6 months after the 2ed treatment
Time Frame
18 months
Title
The Safety of intra-urethral/intravaginal Er:YAG laser procedure by Questionnaire for voiding symptoms (based on IPSS)
Description
The Safety of intra-urethral/intravaginal Er:YAG laser procedure for the treatment of stress urinary incontinence in women, as assessed by questionnaire for voiding symptoms (based on IPSS)
Time Frame
18 months
Secondary Outcome Measure Information:
Title
The effectiveness of the intravaginal and combination of intraurethral/intravaginal laser treatments by recording 3-day voiding diary
Description
The efficacy of intra-urethral/intravaginal Er:YAG laser procedure for the treatment of stress urinary incontinence in women by recording of improvement in daily number of incontinence episodes via 3-day voiding diary The 3-day voiding diary is a log used to record number of pads used, incontinence episodes, the activity in which the subject was engaged when the incontinence occurred, and micturitions.
Time Frame
18 months
Title
The effectiveness of the intravaginal and combination of intraurethral/intravaginal laser treatments by 24-Hour Pad-Weight Test
Description
The 24-Hour Pad-Weight Test will be used to reflect everyday incontinence. This test, standardized by the International Continence Society, correlates well with UI symptoms, and has good reproducibility.
Time Frame
18 months
Title
The effectiveness of the intravaginal and combination of intraurethral/intravaginal laser treatments by ICIQ-UI short form questionnaire
Description
The efficacy of intra-urethral/intravaginal Er:YAG laser procedure for the treatment of stress urinary incontinence in women reduction in SUI as measured by ICIQ-UI short form questionnaire. The ICIQ-UI Short Form Questionnaire provides a brief and robust measure to assess the impact of symptoms of incontinence on quality of life and outcome of treatment.
Time Frame
18 months
Title
The effectiveness of the intravaginal and combination of intraurethral/intravaginal laser treatments by recording patient global impression of improvement (PGI-I)
Description
• The efficacy of intra-urethral/intravaginal Er:YAG laser procedure for the treatment of stress urinary incontinence in women by recording patient global impression of improvement (PGI-I). The Patient Global Impression of Improvement (PGI-I) Questionnaire is a global index that may be used to rate the response of a condition to a therapy (transition scale).
Time Frame
18 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female between 18 and 80 years SUI or MUI with predominantly stress symptoms for more than 6 months Has failed 2 previous non-invasive therapies for three (3) months each (e.g. behavioural modification, electrical stimulation, pelvic muscle exercise, biofeedback, and/or drug therapy) Confirmed SUI through cough stress test or urodynamics Has at least one incontinence episode per 24 hour period measured over three days Valsalva leak-point pressure (VLPP) ≤100 cm H2O Has a baseline 24h pad weight test ≥ 10 gm Has maximum cystometric capacity ≥250 mL No pelvic surgery within last 6 months (including prolapse repair, subjects who have residual or recurrent SUI following colposuspension or a sling procedure may be included in the study if the procedure was conducted at least 6 months prior to screening /baseline visit) Willing to give informed consent and complete the follow up schedule Exclusion Criteria: Active urinary tract or vaginal infection or other active infections of urinary tract or bladder (urethritis, cystitis or vaginitis) Has had three (3) or more cultured-proven bacterial urinary tract infection (UTI) in the last 12 months Clinical diagnosis of urge incontinence or urge predominant mixed incontinence Has detrusor overactivity on urodynamics postvoiding residual (PVR) > 100 ml Has had previous urethral surgery (i.e. fistula or diverticula) Grade 2 or higher Pelvic organ prolapse (POP) or Pelvic organ prolapse grade > 2 as defined by POP-Q and symptomatic Suffers from known polyuria (>3l/24h) Has a BMI ≤35 kg/m2 Has unevaluated hematuria Has a neurogenic bladder Evidence of dysplasia in a Pap smear (done in the last 24 months) Tumours of the Urinary tract Previous radiation or brachytherapy to treat pelvic cancer Has uncontrolled diabetes Has active herpes genitalis Pregnancy, lactating, or not practicing adequate contraception and/or planning to get pregnant in the next 12 months Had a vaginal delivery within 6 months prior to the Screening/Baseline Visit Is currently participating in any other clinical trial, or has participated in another clinical trial within 3 months prior to the Screening/Baseline Visit
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Branka Korosec, PhD
Phone
+386015009185
Email
branka.korosec@fotona.com
Facility Information:
Facility Name
University Urology Associates
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dean S. Elterman, MD
Phone
416 603 5800
Ext
5033
Email
dean.elterman@uhn.ca
First Name & Middle Initial & Last Name & Degree
Iris Chan
Phone
416 603 5800
Ext
5033
Email
Iris.Chan2@uhn.ca
Facility Name
Exgogenia, Institute of Anti-Aging and Regenerative Medicine
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1L 1C6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Le Mai Tu, PhD
Phone
1-819-791-8866
Email
Le.mai.tu@usherbrooke.ca
First Name & Middle Initial & Last Name & Degree
Helen Lavoie
Phone
1-819-791-8866
Email
hlavoie7@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Intraurethral/Intravaginal 2940 nm Erbium Laser Treatment For Stress Urinary Incontinence

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