IUL Study A Randomized Sham - Controlled Clinical Study - Clinical Trial for Stress Urinary Incontinence | NCT04707690

Back to results

Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

Austria

Study Type

Interventional

Intervention

Intraurethral laser therapy

Intraurethral SHAM laser therapy

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring Laser therapy, Stress urinary incontinence, intraurethral

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Female between 18 and 80 years
Confirmed SUI through cough stress test within the last 24 months
SUI I-II° for more than 6 months
At least one incontinence episode per 24 hour period measured over three days according to a bladder diary
Valsalva leak-point pressure (VLPP) ≤60 cm H2O
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)
BMI (body mass index) ≤35 kg/m2
Willing to give informed consent and complete the follow up schedule

Exclusion Criteria:

Active lower urinary tract infections (urethritis, cystitis or vaginitis)
Three (3) or more cultured-proven bacterial urinary tract infection (UTI) in the last 12 months
Detrusor overactivity on urodynamics
Postvoiding residual (PVR) > 100 ml
Previous urethral surgery (i.e. fistula or diverticula)
Pelvic organ prolapse grade > 3 as defined by POP-Q and symptomatic
Known polyuria (>3l/24h)
Unevaluated macro hematuria
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
Uncontrolled diabetes
Active herpes genitalis
Pregnancy
Vaginal delivery within 6 months prior to the Screening/Baseline Visit

Sites / Locations

Departement of Obstetrics and GynecologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Intraurethral laser therapy

Intraurethral SHAM laser therapy

Arm Description

Before treatment the vulva will be carefully inspected to rule out signs of infection or recent trauma. A local anesthetic fluid (Cathejell ®) will be applied to the urethral meatus. Before laser therapy, an intraurethral swab will be taken before treatment in order to determine the intraurethral microbiome. Vulvovaginal laser therapies will be performed with the non-ablative 2940 nm Er:YAG laser (Smooth XS, Fotona, Slovenia) in the Incontinence mode according to the manufacturer's guidelines and recommendations. The spot size (diameter of the laser beam) is 7 mm, with a pulse at a frequency of 1.6 Hz, and a fluence (laser energy delivered per unit area) of 5.0 to 10.0 J/cm2.

Clinical examination and preparations will be identical to the intervention group. Sham laser treatments will be performed with the same laser and the same device. However, a specially designed placebo probe, which blocks the emission of radiation, will be used. Women will therefore receive no therapeutic laser treatment. Before treatment, a study assistant, who is aware of the study allocation, will prepare the laser with the placebo probe, which looks identically to the "normal" probe. The treating physician will not be aware of the study allocation and the type of probe in use.

Outcomes

Primary Outcome Measures

Subjective symptoms of SUI

A visual analogue scale (VAS) is used for assessment for the subjective symptoms and improvement of SUI. Patients are asked to indicate the degree of their symptoms on a scle ranging from 0 (no symptoms) to 10 (worst possible symptoms).

Secondary Outcome Measures

Degree of pain during laser therapy on a visual analogue scale (VAS)

Patients are asked to indicate the degree of pain during laser therapy on a visual analogue scale (VAS) ranging from 0 (no pain) to 10 (worst possible pain).

Subjective SUI

Subjective SUI as determined by the question "do you leak urine when coughing, sneezing or laughing" with the answer possibilities of "Yes" and "No".

Objective SUI

Objective SUI as determined by the cough stress test at 300ml bladder filling, which will either be positive or negative.

Patient Global Impression of Improvement

The PGI-I scales are robust and valid instruments to assess disease severity, bother and improvement after treatment in women and will be used to determine the Patient Global Impression of Improvement. The PGI-I consists of a 7-likert-scale with 7 being the worst bother.

Patient Global Impression of Severity

The Patient Global Impression of Severity (PGI-S) is a global index that may be used to rate the severity of a specific condition (in a single-state scale). The PGI-I scales are robust and valid instruments to assess disease severity, bother and improvement after treatment in women and will be used to determine the Patient Global Impression of Severity. The PGI scales are robust and valid instruments to assess disease severity, bother and improvement after treatment. The patient can choose from 4 answers including none, mild, moderate and severe.

Quality of Life using the Kings Health Questionnaire

The Kings Health Questionnaire was validated in women with stress urinary incontinence and assesses the impact of incontinence on quality of life. The eight subscales ("domains") scored between 0 (best) and 100 (worst). The Symptom Severity scale is scored from 0 (best) to 30 (worst); lower scores indicate better QoL. Success in terms of the study is defined as 10 points improvement on the total Kings Health Questionnaire score.

Pelvic floor symptoms

A validated self-administered pelvic floor questionnaire (Baessler) will be used to assess urogentinal symptoms. Questions regarding bladder (15), bowel (12), and sexual function (10), and pelvic organ prolapse symptoms (five) are grouped according to the physiological functions of the pelvic floor: bladder function, bowel function, prolapse symptoms, and sexual function domains. Quality of life measures and bothersomeness ratings were integrated into the four domains. Frequency, severity, and bothersomeness of pelvic floor symptoms are assessed using a four-point scoring system for most items in the questionnaire, apart from defecation frequency, bowel consistency, sufficient lubrication, and the reason for sexual abstinence. The lower the score the less pelvic floor symptoms the patients have.

Pad Weight

In regards to the one-hour stress pad weight test women are asked to drink 500 ml of sodium-free liquid in <15 min, then sit, walk for 30 min including climbing one flight of stairs. Afterwards the total amount of urine leaked is determined by weighing the pad. Lower weight means less urine loss.

Patient satisfaction with treatment/inpatient management

Patient satisfaction will be evaluated with the "Fragebogen zur Patientenzufriedenheit - ZUF-8". The German version of the original "Client Satisfaction Questionnaire-CSQ8", is a validated tool for measuring global patient satisfaction at the end of inpatient treatment. The ZUF-8 is an 8-items questionnaire to assess satisfaction in patients undergoing inpatient treatment. At 3 months treatment satisfaction will be assessed using an adopted version of the questionnaire. The lower the score, the higher is the patient satisfaction.

Microbiome

Extraction of archaeal/bacterial 16S rRNA gene using the Illumina MiSeq platform in order to determine the intraurethral microbiome

Full Information

NCT ID

NCT04707690

First Posted

January 12, 2021

Last Updated

October 7, 2022

Sponsor

Medical University of Graz

1. Study Identification

Unique Protocol Identification Number

NCT04707690

Brief Title

IUL Study A Randomized Sham - Controlled Clinical Study

Official Title

Intraurethral Laser Therapy for Stress Urinary Incontinence: A Randomized Sham - Controlled Clinical Study

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 8, 2021 (Actual)

Primary Completion Date

January 1, 2024 (Anticipated)

Study Completion Date

January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medical University of Graz

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Product Manufactured in and Exported from the U.S.

No

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Primary aim of the study is to compare the impact of SUI on the VAS (visual analogue scale) 3 months after laser therapy versus sham laser therapy.

Detailed Description

Background: Stress urinary incontinence (SUI) has a huge impact on the quality of life (QoL) in women and its treatment is challenging. Intraurethral laser may be an additional treatment option. Study aim: The aim is to study the effectiveness of intraurethral laser therapy in women with SUI. Design: randomized double blinded sham - controlled clinical study Study population: women which have been diagnosed with SUI I-II°, aged between 18-80 years. Study groups: Participants will be randomized (1:1), without stratification. The Intervention group will receive 2 treatments of intraurethral laser therapy and the Control group will receive 2 treatments of intraurethral SHAM laser therapy. Sample size: A sample size of 20 women, 8 per group including a 20% Drop Out Rate, was calculated. Primary outcome: impact of SUI on the VAS scale 3 months after laser therapy versus sham laser therapy. Secondary study outcomes were defined as subjective SUI, objective SUI, QoL, treatment satisfaction, intraurethral microbiome, 3 months after laser therapy versus sham laser therapy.

6. Conditions and Keywords

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

Stress Urinary Incontinence

Keywords

Laser therapy, Stress urinary incontinence, intraurethral

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Prospective randomized sham - controlled trial

Masking

ParticipantCare Provider

Masking Description

Eligible patients will receive written and oral information about the study. After informed consent patients will be randomized into the intraurethral laser treatment group or sham laser group using the internet based program "randomizer", at a 1.1 ratio without stratification. Patients and the person performing the laser treatment will not aware of the treatment given. The laser devices can be used as a placebo laser blocking the laser beam with a plug.

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intraurethral laser therapy

Arm Type

Active Comparator

Arm Description

Before treatment the vulva will be carefully inspected to rule out signs of infection or recent trauma. A local anesthetic fluid (Cathejell ®) will be applied to the urethral meatus. Before laser therapy, an intraurethral swab will be taken before treatment in order to determine the intraurethral microbiome. Vulvovaginal laser therapies will be performed with the non-ablative 2940 nm Er:YAG laser (Smooth XS, Fotona, Slovenia) in the Incontinence mode according to the manufacturer's guidelines and recommendations. The spot size (diameter of the laser beam) is 7 mm, with a pulse at a frequency of 1.6 Hz, and a fluence (laser energy delivered per unit area) of 5.0 to 10.0 J/cm2.

Arm Title

Intraurethral SHAM laser therapy

Arm Type

Placebo Comparator

Arm Description

Clinical examination and preparations will be identical to the intervention group. Sham laser treatments will be performed with the same laser and the same device. However, a specially designed placebo probe, which blocks the emission of radiation, will be used. Women will therefore receive no therapeutic laser treatment. Before treatment, a study assistant, who is aware of the study allocation, will prepare the laser with the placebo probe, which looks identically to the "normal" probe. The treating physician will not be aware of the study allocation and the type of probe in use.

Intervention Type

Device

Intervention Name(s)

Intraurethral laser therapy

Other Intervention Name(s)

Fotona smooth XS laser

Intervention Description

The laser will be applied according to the manufacturer's protocol. This includes a 2 step laser treatment using 2 different modes at 2 timepoints. The treatment takes about 15 minutes time.

Intervention Type

Device

Intervention Name(s)

Intraurethral SHAM laser therapy

Other Intervention Name(s)

Fotona smooth XS laser

Intervention Description

The laser will be applied according to the manufacturer's protocol. This includes a 2 step laser treatment using 2 different modes at 2 timepoints. The treatment takes about 15 minutes time.

Primary Outcome Measure Information:

Title

Subjective symptoms of SUI

Description

A visual analogue scale (VAS) is used for assessment for the subjective symptoms and improvement of SUI. Patients are asked to indicate the degree of their symptoms on a scle ranging from 0 (no symptoms) to 10 (worst possible symptoms).

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Degree of pain during laser therapy on a visual analogue scale (VAS)

Description

Patients are asked to indicate the degree of pain during laser therapy on a visual analogue scale (VAS) ranging from 0 (no pain) to 10 (worst possible pain).

Time Frame

3 months

Title

Subjective SUI

Description

Subjective SUI as determined by the question "do you leak urine when coughing, sneezing or laughing" with the answer possibilities of "Yes" and "No".

Time Frame

3 months

Title

Objective SUI

Description

Objective SUI as determined by the cough stress test at 300ml bladder filling, which will either be positive or negative.

Time Frame

3 months

Title

Patient Global Impression of Improvement

Description

The PGI-I scales are robust and valid instruments to assess disease severity, bother and improvement after treatment in women and will be used to determine the Patient Global Impression of Improvement. The PGI-I consists of a 7-likert-scale with 7 being the worst bother.

Time Frame

3 months

Title

Patient Global Impression of Severity

Description

The Patient Global Impression of Severity (PGI-S) is a global index that may be used to rate the severity of a specific condition (in a single-state scale). The PGI-I scales are robust and valid instruments to assess disease severity, bother and improvement after treatment in women and will be used to determine the Patient Global Impression of Severity. The PGI scales are robust and valid instruments to assess disease severity, bother and improvement after treatment. The patient can choose from 4 answers including none, mild, moderate and severe.

Time Frame

3 months

Title

Quality of Life using the Kings Health Questionnaire

Description

The Kings Health Questionnaire was validated in women with stress urinary incontinence and assesses the impact of incontinence on quality of life. The eight subscales ("domains") scored between 0 (best) and 100 (worst). The Symptom Severity scale is scored from 0 (best) to 30 (worst); lower scores indicate better QoL. Success in terms of the study is defined as 10 points improvement on the total Kings Health Questionnaire score.

Time Frame

3 months

Title

Pelvic floor symptoms

Description

A validated self-administered pelvic floor questionnaire (Baessler) will be used to assess urogentinal symptoms. Questions regarding bladder (15), bowel (12), and sexual function (10), and pelvic organ prolapse symptoms (five) are grouped according to the physiological functions of the pelvic floor: bladder function, bowel function, prolapse symptoms, and sexual function domains. Quality of life measures and bothersomeness ratings were integrated into the four domains. Frequency, severity, and bothersomeness of pelvic floor symptoms are assessed using a four-point scoring system for most items in the questionnaire, apart from defecation frequency, bowel consistency, sufficient lubrication, and the reason for sexual abstinence. The lower the score the less pelvic floor symptoms the patients have.

Time Frame

3 months

Title

Pad Weight

Description

In regards to the one-hour stress pad weight test women are asked to drink 500 ml of sodium-free liquid in <15 min, then sit, walk for 30 min including climbing one flight of stairs. Afterwards the total amount of urine leaked is determined by weighing the pad. Lower weight means less urine loss.

Time Frame

3 months

Title

Patient satisfaction with treatment/inpatient management

Description

Patient satisfaction will be evaluated with the "Fragebogen zur Patientenzufriedenheit - ZUF-8". The German version of the original "Client Satisfaction Questionnaire-CSQ8", is a validated tool for measuring global patient satisfaction at the end of inpatient treatment. The ZUF-8 is an 8-items questionnaire to assess satisfaction in patients undergoing inpatient treatment. At 3 months treatment satisfaction will be assessed using an adopted version of the questionnaire. The lower the score, the higher is the patient satisfaction.

Time Frame

3 months

Title

Microbiome

Description

Extraction of archaeal/bacterial 16S rRNA gene using the Illumina MiSeq platform in order to determine the intraurethral microbiome

Time Frame

3 months

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

Only females can participate in this study because it is led by gynecologists.

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Female between 18 and 80 years Confirmed SUI through cough stress test within the last 24 months SUI I-II° for more than 6 months At least one incontinence episode per 24 hour period measured over three days according to a bladder diary Valsalva leak-point pressure (VLPP) ≤60 cm H2O 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) BMI (body mass index) ≤35 kg/m2 Willing to give informed consent and complete the follow up schedule Exclusion Criteria: Active lower urinary tract infections (urethritis, cystitis or vaginitis) Three (3) or more cultured-proven bacterial urinary tract infection (UTI) in the last 12 months Detrusor overactivity on urodynamics Postvoiding residual (PVR) > 100 ml Previous urethral surgery (i.e. fistula or diverticula) Pelvic organ prolapse grade > 3 as defined by POP-Q and symptomatic Known polyuria (>3l/24h) Unevaluated macro hematuria 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 Uncontrolled diabetes Active herpes genitalis Pregnancy Vaginal delivery within 6 months prior to the Screening/Baseline Visit

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Daniela Gold, MD PhD

Phone

0043316 385 81437

Email

daniela.gold@medunigraz.at

Facility Information:

Facility Name

Departement of Obstetrics and Gynecology

City

Graz

State/Province

Styria

ZIP/Postal Code

8036

Country

Austria

Individual Site Status

Recruiting

Facility Contact: