Intraurethral/Intravaginal 2940 Nm Erbium Laser Treatment for Stress Urinary Incontinence

NCT03676894 | Completed

• 1 other identifier: SPD16-001-00
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 2

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.

Conditions

Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (5)

• 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.

  18 months

• 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

  18 months

• 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

  18 months

• 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

  18 months

• 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)

  18 months

Secondary Outcomes (4)

• The effectiveness of the intravaginal and combination of intraurethral/intravaginal laser treatments by recording 3-day voiding diary

  18 months

• The effectiveness of the intravaginal and combination of intraurethral/intravaginal laser treatments by 24-Hour Pad-Weight Test

  18 months

• The effectiveness of the intravaginal and combination of intraurethral/intravaginal laser treatments by ICIQ-UI short form questionnaire

  18 months

• The effectiveness of the intravaginal and combination of intraurethral/intravaginal laser treatments by recording patient global impression of improvement (PGI-I)

  18 months

Study Arms (3)

Sham Treatment

SHAM COMPARATOR

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

Device: Sham Fotona SP Dynamis

Intravaginal Treatment

ACTIVE COMPARATOR

Intravaginal Fotona SP Dynamis Treatment - energy delivered intravaginally.

Device: Intravaginal Fotona SP Dynamis

Intravaginal and intraurethral Treatment

EXPERIMENTAL

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

Device: Intravaginal Fotona SP Dynamis; Device: Intraurethral Fotona SP Dynamis

Interventions

Sham Fotona SP Dynamis DEVICE

Female patients with SUI will be treated with non-ablative Er:YAG laser with Fotona SP Dynamis with sham handpiece.

Sham Treatment

Intravaginal Fotona SP Dynamis DEVICE

Female patients with SUI will be treated intravaginaly with non-ablative Er:YAG laser with Fotona SP Dynamis

Intravaginal Treatment; Intravaginal and intraurethral Treatment

Intraurethral Fotona SP Dynamis DEVICE

Female patients with SUI will be treated intraurethraly with non-ablative Er:YAG laser with Fotona SP Dynamis

Intravaginal and intraurethral Treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fotona d.o.o.: lead

Study Sites (2)

University Urology Associates

Toronto, Ontario, M5T 2S8, Canada

Location

Exgogenia, Institute of Anti-Aging and Regenerative Medicine

Sherbrooke, Quebec, J1L 1C6, Canada

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, randomized, 3-arm parallel pilot study

Study Record Dates

• First Submitted: September 10, 2018
• First Posted: September 19, 2018
• Study Start: June 4, 2018
• Primary Completion: November 28, 2022
• Study Completion: May 23, 2023
• Last Updated: March 13, 2025

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)