Stress Urinary IncontinenceNCT04143867
The Nolix Feasibility Efficacy and Safety Study
A study testing Nolix Device in people with Stress Urinary Incontinence, run by Gynamics LTD at 1 site in Israel.
Trial summary
This study is an open label, prospective, feasibility study with the Nolix device used for temporary treatment of Stress Urinary Incontinence (SUI) in subjects, serving as their own controls. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Nolix Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jan 2019to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females aged 22 and above.
- Suffering from Stress Urinary Incontinence.
- Women who can understand the nature of the study, are physically able to perform all required tasks and consent to it by signing a written Informed Consent Form prior to participation in the study.
Who cannot join
- Age ≤ 21 years.
- Pregnant or planning to become pregnant during the study.
- Vaginal birth or Cesarean section for the last 3 months prior to entering the study.
- Severely atrophic vagina.
- A history of Toxic Shock Syndrome (TSS).
- Active urinary tract or vaginal infection.
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- Patients prone to recurrent vaginal or urinary tract infections (i.e. more than 3 times in the past year).
- Has experienced unusual or unexpected vaginal bleeding within the last 6 months.
- Vaginal surgery within the last 3 months prior to entering the study.
- Has experienced difficulties with the use of intra-vaginal devices, including tampons.
- Presence of any condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
- Average daily PWG as measured in the baseline pad period is less than 4 grams /12 hours.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Feasibility Efficacy and Safety Study of the Nolix Vaginal Device for the Temporary Management of Stress Urinary Incontinence in Women
This study is an open label, prospective, feasibility study with the Nolix device used for temporary treatment of Stress Urinary Incontinence (SUI) in subjects, serving as their own controls.
Read the detailed description
This is an open label, prospective, feasibility study with the Nolix device used in subjects with SUI, serving as their own controls. The objective of this study is to evaluate the effectiveness (both objective and subjective) and safety of the Nolix device when used for the temporary management of SUI in women. In addition, the study is aimed to evaluate changes in the quality of life (QoL) and comfort during use of the Nolix device. The primary effectiveness endpoint is the percent change in the mean Pad Weight Gain (%PWG) between the device (during the last 7 days of the 14-days Nolix use period) and control periods , with the success criterion defined as at least >-50% of the mean %PWG change during the last 7 days of the treatment phase as compared to the control phase. Additional effectiveness endpoints include the number of self-reported SUI episodes per week, the percentage of subjects who experience a greater than -50% change in the number of self-reported daily incontinence episodes, as well as the changes in the QoL, leak scores and overall satisfaction levels. The safety of the Nolix device is also evaluated by assessing the adverse events, including the results of urinalysis, vaginal swab, and vaginal examination.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Nolix Device
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nolix DeviceDevice
For temporary management of SUI
| Study group | Role | What they receive |
|---|---|---|
| Nolix Device | Experimental | Comparing use of device to non-treatment (pads only) phase Receives: Device: Nolix Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean pad weight gain (PWG) change of >50% when comparing the PWG control phase as compared to the Nolix device phase.
The primary effectiveness endpoint is the percent change in the mean Pad Weight Gain (%PWG) between the device (during the last 7 days of the 14-days Nolix use period) and control periods , with the success criterion defined as at least >50% of the mean %PWG reduction during the last 7 days of the treatment phase as compared to the control phase.
Measured: 21 days
Device-related adverse events
Discomfort / pain, vaginal irritation or itching, vaginal spotting, vaginal or urinary tract infections
Measured: 21 days
Secondary outcomes (8)
Change in number of self-reported incontinence episodes.
Change in number of self-reported incontinence episodes per week from the control period to the Nolix device use period.
Measured: 21 days
More than 50% reduction in the number of self-reported daily incontinence episodes.
Percentage of subjects who experience a greater than 50% reduction in the number of self-reported daily incontinence episodes from the baseline period to the Nolix device use period.
Measured: 21 days
Changes in Quality of Life (QoL).
The QoL Questionnaire (measured on a 0-100 scale) will be performed at baseline and after the device-use period and refer to areas which may have been influenced or changed by accidental urine loss and/or prolapse. A lower score is considered less impact to quality of life and a higher score reflects more impact to quality of life. In the same manner, a reduction in scores from baseline reflects improved quality of life.
Measured: 21 days
Changes in Leak Score.
Changes in Leak Score from the baseline period to the Nolix device use period, as measured using the Leak Score Questionnaire. The Leak Score Questionnaire will be performed (on a 0-3 scale) to evaluate the subjective perception of incontinence during eight effort demanding activities: coughing, laughing, sneezing, jumping, lifting heavy objects, walking, running, and going to the gym.
Measured: 21 days
PWG measured continuously.
PWG measured continuously (as opposed to responder analysis), using the same definition of PWG as described above, without transformation to percent.
Measured: 21 days
Comfort during Nolix device use.
Comfort during Nolix device use will be measured through the Satisfaction Questionnaire, using a 10-point scale (where 1 is the most negative response and 10 the most positive, during the use of the device).
Measured: 21 days
Overall perception of improvement.
Overall perception of improvement following the use of the Nolix device, as measured using the Patient Global Impression of Improvement (PGI-I) Scale, measured on a 7-point scale (where 1 is the most positive response and 7 the most negative response).
Measured: 21 days
Overall satisfaction: Patient Satisfaction Question (PSQ)
Overall satisfaction with the use of the Nolix device, as measured using the Patient Satisfaction Question (PSQ),selecting one of the following answers: 'Completely'; 'Somewhat'; or 'Not at all'.
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study start1 Jan 2019
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- A prospective, one-arm study with subjects serving as their own control.
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynamics LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boris Fridman, Dr., Principal investigator, Carmel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04143867
- Sponsor's protocol ID
- NLX-002
- Status last verified
- Aug 2021
- First submitted
- 22 Oct 2019
- Last updated
- 16 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All personal data gathered in this trial will be treated in strictest confidence by investigators, monitors, sponsor's personnel and independent ethics committee.
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Efficacy and Safety Study of the Nolix Vaginal Device for the Temporary Management of Stress Urinary Incontinence in Women
- ClinicalTrials.gov ID
- NCT04143867
- Acronym / sponsor ID
- NLX-002
- Conditions
- Stress Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Gynamics LTDIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 29 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is an open label, prospective, feasibility study with the Nolix device used for temporary treatment of Stress Urinary Incontinence (SUI) in subjects, serving as their own controls.
Detailed description
This is an open label, prospective, feasibility study with the Nolix device used in subjects with SUI, serving as their own controls. The objective of this study is to evaluate the effectiveness (both objective and subjective) and safety of the Nolix device when used for the temporary management of SUI in women. In addition, the study is aimed to evaluate changes in the quality of life (QoL) and comfort during use of the Nolix device. The primary effectiveness endpoint is the percent change in the mean Pad Weight Gain (%PWG) between the device (during the last 7 days of the 14-days Nolix use period) and control periods , with the success criterion defined as at least >-50% of the mean %PWG change during the last 7 days of the treatment phase as compared to the control phase. Additional effectiveness endpoints include the number of self-reported SUI episodes per week, the percentage of subjects who experience a greater than -50% change in the number of self-reported daily incontinence episodes, as well as the changes in the QoL, leak scores and overall satisfaction levels. The safety of the Nolix device is also evaluated by assessing the adverse events, including the results of urinalysis, vaginal swab, and vaginal examination.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A prospective, one-arm study with subjects serving as their own control.
| Arm | Type | Receives |
|---|---|---|
| Nolix Device | Experimental | Device: Nolix DeviceComparing use of device to non-treatment (pads only) phase |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Females aged 22 and above.
- Suffering from Stress Urinary Incontinence.
- Women who can understand the nature of the study, are physically able to perform all required tasks and consent to it by signing a written Informed Consent Form prior to participation in the study.
Key exclusion criteria (12 listed)
- Age ≤ 21 years.
- Pregnant or planning to become pregnant during the study.
- Vaginal birth or Cesarean section for the last 3 months prior to entering the study.
- Severely atrophic vagina.
- A history of Toxic Shock Syndrome (TSS).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nolix DeviceFor temporary management of SUI | Device | Nolix Device |
Primary outcome
Mean pad weight gain (PWG) change of >50% when comparing the PWG control phase as compared to the Nolix device phase.
Time frame: 21 days
The primary effectiveness endpoint is the percent change in the mean Pad Weight Gain (%PWG) between the device (during the last 7 days of the 14-days Nolix use period) and control periods , with the success criterion defined as at least >50% of the mean %PWG reduction during the last 7 days of the treatment phase as compared to the control phase.
Device-related adverse events
Time frame: 21 days
Discomfort / pain, vaginal irritation or itching, vaginal spotting, vaginal or urinary tract infections
8 secondary outcomes
Change in number of self-reported incontinence episodes.
Time frame: 21 days
More than 50% reduction in the number of self-reported daily incontinence episodes.
Time frame: 21 days
Changes in Quality of Life (QoL).
Time frame: 21 days
Changes in Leak Score.
Time frame: 21 days
PWG measured continuously.
Time frame: 21 days
Comfort during Nolix device use.
Time frame: 21 days
Overall perception of improvement.
Time frame: 21 days
Overall satisfaction: Patient Satisfaction Question (PSQ)
Time frame: 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2021.
- Individual participant dataSharing planned: No. All personal data gathered in this trial will be treated in strictest confidence by investigators, monitors, sponsor's personnel and independent ethics committee.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boris Fridman, Dr. principal investigator
Carmel Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nolix Device in people with Stress Urinary Incontinence, run by Gynamics LTD at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean pad weight gain (PWG) change of >50% when comparing the PWG control phase as compared to the Nolix device phase. (time frame: 21 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2021.