Urinary Stress IncontinencePhase 3NCT04812574

Hypertonic Saline Injection For Urinary Incontinence

A Phase 3 study testing Periurethral injection and Hypertonic (10%) saline in people with Urinary Stress Incontinence, run by Turgut Ozal University at 2 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The investigators aimed to evaluate the effectiveness and safety of periurethral hypertonic saline (10% NaCl) injection for the treatment of stress urinary incontinence (SUI) and stress-predominant mixed urinary incontinence (MUI) in women. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Urinary Stress Incontinence
What is being tested?: Periurethral injection and Hypertonic (10%) saline
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 65 participants
Where: 2 sitesTurkey (Türkiye)
Study dates: 1 Jan 2014to 1 Jun 2020
Phase: Phase 3
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 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

The patients who described Stress Urinary Incontinence or Mixed Urinary Incontinence, those who had incontinence during the Valsalva maneuver, patients with positive Marshal-Marchetti test, and those with post-void residual urine volume ≤100 mL were included in the study.

Who cannot join

Temporary urinary incontinence, delirium, urinary tract infection, urethritis, pure urge incontinence, nocturnal enuresis, decreased bladder compliance and detrusor contraction in the urodynamic study, leakage of urine with low bladder pressure, psychiatric conditions (severe depression and anxiety), body mass index (BMI) >35 kg/m2, and using drugs that may influence bladder storage or emptying

Trial locations and contacts

2 sites in 1 country.

Turkey (Türkiye)2 sites

Turgut Ozal University
Malatya, 44100
İnonu University
Malatya, 44120

Other trials in Turkey (Türkiye)

About this study

Official title: Periurethral Hypertonic Saline (10%) Injection for Female Stress Urinary Incontinence and Stress-Predominant Mixed Urinary Incontinence

Read the detailed description

This single-center prospective pre-post interventional study was conducted between January 2014 and April 2018 with 65 women (44 SUI, 21 MUI). Quality of life was evaluated with the Incontinence Quality of Life Scale (I-QoL) and the lower urinary tract symptoms of women were evaluated with the International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS). Incontinence status was assessed via the Stamey Incontinence Grade scale. Patients with MUI also were evaluated using the Urinary Distress Inventory-6 (UDI-6). The need for additional treatment (re-injection, other surgical approaches, etc.) was recorded.

Participants were followed up to 24 months after intervention. All outcomes of interest and complications were evaluated/recorded at six preplanned visits (postoperative 1st, 3rd, 6th, 12th, 18th, 24th months).

Conditions: Urinary Stress Incontinence
Being tested: Periurethral injection, Hypertonic (10%) saline
Keywords: Female, Stress Urinary Incontinence, Stress-Predominant Mixed Incontinence, Hypertonic Saline Injection, Therapy
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.

Periurethral injectionProcedure or surgery
Patients were in the lithotomy position for the procedure. After preparation, topical Lidocaine gel was instilled around the meatus and a 16 F probe was attached. The catheter balloon was inflated to localize the bladder neck and to ensure that injections were performed in the correct anatomical plane. Hypertonic saline (10% NaCl) was injected to the alignment of the urethral meatus in the order of 3-6-9-12 hours of the clock (5 cc to each site, totaling 20 cc). Syringes with 27 Gauge (0.40 mm) outer diameter were used to ensure controlled injection. Since the female urethra is about 4 cm in length, the needle was advanced about 3 cm. Due to the possibility of significant pain with hypertonic saline, 2 cc of Lidocaine hydrochloride was added into the solution.
Hypertonic (10%) salineDrug
Also called 10% NaCl solution
Periurethral hypertonic saline (10%)

Study groups in NCT04812574
Study group	Role	What they receive
Hypertonic Saline (10%) Injection	Experimental	Periurethral hypertonic saline (10%) injection was performed in female patients with Stress Urinary Incontinence or Stress-Predominant Mixed Urinary Incontinence. Receives: Procedure: Periurethral injection; Drug: Hypertonic (10%) saline

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in the Stamey Incontinence Grade at 24 months
All patients (SUI and MUI) were evaluated as follows: Grade 0: No incontinence; Grade 1: Incontinence with coughing or straining; Grade 2: Incontinence with change in position or walking; Grade 3: Total incontinence at all times
Measured: Change from baseline at 24 months
Change in the Urinary Distress Inventory-6 (UDI-6) scores at 1 month
Only MUI patients were evaluated with UDI-6 scale. UDI-6 is a validated 6-item questionnaire that assesses lower urinary tract symptoms, including incontinence, in women.
Measured: Change from baseline at 1 month
Change in the Urinary Distress Inventory-6 (UDI-6) scores at 3 months
Only MUI patients were evaluated with UDI-6 scale. UDI-6 is a validated 6-item questionnaire that assesses lower urinary tract symptoms, including incontinence, in women.
Measured: Change from baseline at 3 months
Change in the Urinary Distress Inventory-6 (UDI-6) scores at 6 months
Only MUI patients were evaluated with UDI-6 scale. UDI-6 is a validated 6-item questionnaire that assesses lower urinary tract symptoms, including incontinence, in women.
Measured: Change from baseline at 6 months
Change in the Urinary Distress Inventory-6 (UDI-6) at 12 months
Only MUI patients were evaluated with UDI-6 scale. UDI-6 is a validated 6-item questionnaire that assesses lower urinary tract symptoms, including incontinence, in women.
Measured: Change from baseline at 12 months
Change in the Urinary Distress Inventory-6 (UDI-6) scores at 18 months
Only MUI patients were evaluated with UDI-6 scale. UDI-6 is a validated 6-item questionnaire that assesses lower urinary tract symptoms, including incontinence, in women.
Measured: Change from baseline 18 months
Change in the Urinary Distress Inventory-6 (UDI-6) scores at 24 months
Only MUI patients were evaluated with UDI-6 scale. UDI-6 is a validated 6-item questionnaire that assesses lower urinary tract symptoms, including incontinence, in women.
Measured: Change from baseline 24 months
Change in the Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS) scores at 1 month
All patients (SUI and MUI) were evaluated with the ICIQ-FLUTS which is a questionnaire for evaluating female lower urinary tract symptoms and impact on quality of life of the patients.
Measured: Change from baseline at 1 month
Change in the Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS) scores at 3 months
All patients (SUI and MUI) were evaluated with the ICIQ-FLUTS which is a questionnaire for evaluating female lower urinary tract symptoms and impact on quality of life of the patients.
Measured: Change from baseline at 3 months
Change in the Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS) scores at 6 months
All patients (SUI and MUI) were evaluated with the ICIQ-FLUTS which is a questionnaire for evaluating female lower urinary tract symptoms and impact on quality of life of the patients.
Measured: Change from baseline at 6 months
Change in the Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS) scores at 12 months
All patients (SUI and MUI) were evaluated with the ICIQ-FLUTS which is a questionnaire for evaluating female lower urinary tract symptoms and impact on quality of life of the patients.
Measured: Change from baseline at 12 months
Change in the Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS) scores at 18 months
All patients (SUI and MUI) were evaluated with the ICIQ-FLUTS which is a questionnaire for evaluating female lower urinary tract symptoms and impact on quality of life of the patients.
Measured: Change from baseline at 18 months
Change in the Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS) scores at 24 months
All patients (SUI and MUI) were evaluated with the ICIQ-FLUTS which is a questionnaire for evaluating female lower urinary tract symptoms and impact on quality of life of the patients.
Measured: Change from baseline at 24 months
Change in the Incontinence Quality of Life Scale (I-QOL) scores at 1 month
All patients (SUI and MUI) were evaluated with the I-QOL which has 22 questions with the following 3 subscales: avoid and limiting behaviors (items), psychosocial impacts (9 items), and social embarassment (5 items).
Measured: Change from baseline at 1 month
Change in the Incontinence Quality of Life Scale (I-QOL) scores at 3 months
All patients (SUI and MUI) were evaluated with the I-QOL which has 22 questions with the following 3 subscales: avoid and limiting behaviors (items), psychosocial impacts (9 items), and social embarassment (5 items).
Measured: Change from baseline at 3 months
Change in the Incontinence Quality of Life Scale (I-QOL) scores at 6 months
All patients (SUI and MUI) were evaluated with the I-QOL which has 22 questions with the following 3 subscales: avoid and limiting behaviors (items), psychosocial impacts (9 items), and social embarassment (5 items).
Measured: Change from baseline at 6 months
Change in the Incontinence Quality of Life Scale (I-QOL) scores at 12 months
All patients (SUI and MUI) were evaluated with the I-QOL which 22 questions with the following 3 subscales: avoid and limiting behaviors (items), psychosocial impacts (9 items), and social embarassment (5 items).
Measured: Change from baseline at 12 months
Change in the Incontinence Quality of Life Scale (I-QOL) scores at 18 months
All patients (SUI and MUI) were evaluated with the I-QOL which has 22 questions with the following 3 subscales: avoid and limiting behaviors (items), psychosocial impacts (9 items), and social embarassment (5 items).
Measured: Change from baseline at 18 months
Change in the Incontinence Quality of Life Scale (I-QOL) scores at 24 months
All patients (SUI and MUI) were evaluated with the I-QOL which has 22 questions with the following 3 subscales: avoid and limiting behaviors (items), psychosocial impacts (9 items), and social embarassment (5 items).
Measured: Change from baseline at 24 months
Need for addtional treatment within the 1st month
Patients who are needed to treat with re-injection or other surgercal approaches.
Measured: Within the 1st month
Need for addtional treatment within 3 months after internvention.
Patients who are needed to treat with re-injection or other surgercal approaches.
Measured: Within the 3 months after internvention.
Need for addtional treatment within 6 months after internvention.
Patients who are needed to treat with re-injection or other surgercal approaches.
Measured: Within the 6 months after internvention.
Need for addtional treatment within 12 months after internvention.
Patients who are needed to treat with re-injection or other surgercal approaches.
Measured: Within the 12 months after internvention.
Need for addtional treatment within 18 months after internvention.
Patients who are needed to treat with re-injection or other surgercal approaches.
Measured: Within the 18 months after internvention.
Need for addtional treatment within 24 months after internvention.
Patients who are needed to treat with re-injection or other surgercal approaches.
Measured: Within the 24 months after internvention.
Presence of complication within 24 months after intervention
Presence of complication such as infection at injection site, urinary tract infection, hematuria, persistent pain, de novo urge incontinence) in all patients.
Measured: Within 24 months after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 20141 Jun 2020

First posted23 Mar 2021
Study start1 Jan 2014
Primary completion1 Apr 2018
Study completion1 Jun 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Urinary Stress 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 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: This is a single-center prospective before-after (pre-post) interventional study, in which the effectiveness and safety of periurethral hypertonic saline injection were evaluated in female stress urinary incontinence and stress-predominant mixed urinary incontinence patients.
Masking: None (open label)
Enrolment: 65 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04812574
Sponsor's protocol ID: 6175679-514.04.01-E.28641
Status last verified: Mar 2021
First submitted: 4 Feb 2021
Last updated: 23 Mar 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: yes

Publications

Irwin GM. Urinary Incontinence. Prim Care. 2019 Jun;46(2):233-242. doi: 10.1016/j.pop.2019.02.004. Epub 2019 Apr 5.
PubMed 31030824
Muth CC. Urinary Incontinence in Women. JAMA. 2017 Oct 24;318(16):1622. doi: 10.1001/jama.2017.15571. No abstract available.
PubMed 29067430

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Urinary Stress Incontinence trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Periurethral Hypertonic Saline (10%) Injection for Female Stress Urinary Incontinence and Stress-Predominant Mixed Urinary Incontinence
ClinicalTrials.gov ID: NCT04812574
Acronym / sponsor ID: 6175679-514.04.01-E.28641
Conditions: Urinary Stress Incontinence
Keywords: Female, Stress Urinary Incontinence, Stress-Predominant Mixed Incontinence, Hypertonic Saline Injection, Therapy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 65 participants (actual)
Lead sponsor: Turgut Ozal UniversityUniversity, hospital or other
Collaborators: Inonu University
Study start: 1 Jan 2014 (actual)
Primary completion: 1 Apr 2018 (actual)
Study completion: 1 Jun 2020 (actual)
First posted: 23 Mar 2021 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: This is a single-center prospective before-after (pre-post) interventional study, in which the effectiveness and safety of periurethral hypertonic saline injection were evaluated in female stress urinary incontinence and stress-predominant mixed urinary incontinence patients.

Arm	Type	Receives
Hypertonic Saline (10%) Injection	Experimental	Procedure: Periurethral injection, Drug: Hypertonic (10%) salinePeriurethral hypertonic saline (10%) injection was performed in female patients with Stress Urinary Incontinence or Stress-Predominant Mixed Urinary Incontinence.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

The patients who described Stress Urinary Incontinence or Mixed Urinary Incontinence, those who had incontinence during the Valsalva maneuver, patients with positive Marshal-Marchetti test, and those with post-void residual urine volume ≤100 mL were included in the study.

Key exclusion criteria (1 listed)

Temporary urinary incontinence, delirium, urinary tract infection, urethritis, pure urge incontinence, nocturnal enuresis, decreased bladder compliance and detrusor contraction in the urodynamic study, leakage of urine with low bladder pressure, psychiatric conditions (severe depression and anxiety), body mass index (BMI) >35 kg/m2, and using drugs that may influence bladder storage or emptying

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
Periurethral injectionPatients were in the lithotomy position for the procedure. After preparation, topical Lidocaine gel was instilled around the meatus and a 16 F probe was attached. The catheter balloon was inflated to localize the bladder neck and to ensure that injections were performed in the correct anatomical plane. Hypertonic saline (10% NaCl) was injected to the alignment of the urethral meatus in the order of 3-6-9-12 hours of the clock (5 cc to each site, totaling 20 cc). Syringes with 27 Gauge (0.40 mm) outer diameter were used to ensure controlled injection. Since the female urethra is about 4 cm in length, the needle was advanced about 3 cm. Due to the possibility of significant pain with hypertonic saline, 2 cc of Lidocaine hydrochloride was added into the solution.	Procedure or surgery	Hypertonic Saline (10%) Injection
Hypertonic (10%) salineAlso: 10% NaCl solutionPeriurethral hypertonic saline (10%)	Drug	Hypertonic Saline (10%) Injection

Primary outcome

Change in the Stamey Incontinence Grade at 24 months
Time frame: Change from baseline at 24 months
All patients (SUI and MUI) were evaluated as follows: Grade 0: No incontinence; Grade 1: Incontinence with coughing or straining; Grade 2: Incontinence with change in position or walking; Grade 3: Total incontinence at all times
Change in the Urinary Distress Inventory-6 (UDI-6) scores at 1 month
Time frame: Change from baseline at 1 month
Only MUI patients were evaluated with UDI-6 scale. UDI-6 is a validated 6-item questionnaire that assesses lower urinary tract symptoms, including incontinence, in women.
Change in the Urinary Distress Inventory-6 (UDI-6) scores at 3 months
Time frame: Change from baseline at 3 months
Only MUI patients were evaluated with UDI-6 scale. UDI-6 is a validated 6-item questionnaire that assesses lower urinary tract symptoms, including incontinence, in women.
Change in the Urinary Distress Inventory-6 (UDI-6) scores at 6 months
Time frame: Change from baseline at 6 months
Only MUI patients were evaluated with UDI-6 scale. UDI-6 is a validated 6-item questionnaire that assesses lower urinary tract symptoms, including incontinence, in women.
Change in the Urinary Distress Inventory-6 (UDI-6) at 12 months
Time frame: Change from baseline at 12 months
Only MUI patients were evaluated with UDI-6 scale. UDI-6 is a validated 6-item questionnaire that assesses lower urinary tract symptoms, including incontinence, in women.
Change in the Urinary Distress Inventory-6 (UDI-6) scores at 18 months
Time frame: Change from baseline 18 months
Only MUI patients were evaluated with UDI-6 scale. UDI-6 is a validated 6-item questionnaire that assesses lower urinary tract symptoms, including incontinence, in women.
Change in the Urinary Distress Inventory-6 (UDI-6) scores at 24 months
Time frame: Change from baseline 24 months
Only MUI patients were evaluated with UDI-6 scale. UDI-6 is a validated 6-item questionnaire that assesses lower urinary tract symptoms, including incontinence, in women.
Change in the Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS) scores at 1 month
Time frame: Change from baseline at 1 month
All patients (SUI and MUI) were evaluated with the ICIQ-FLUTS which is a questionnaire for evaluating female lower urinary tract symptoms and impact on quality of life of the patients.
Change in the Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS) scores at 3 months
Time frame: Change from baseline at 3 months
All patients (SUI and MUI) were evaluated with the ICIQ-FLUTS which is a questionnaire for evaluating female lower urinary tract symptoms and impact on quality of life of the patients.
Change in the Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS) scores at 6 months
Time frame: Change from baseline at 6 months
All patients (SUI and MUI) were evaluated with the ICIQ-FLUTS which is a questionnaire for evaluating female lower urinary tract symptoms and impact on quality of life of the patients.
Change in the Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS) scores at 12 months
Time frame: Change from baseline at 12 months
All patients (SUI and MUI) were evaluated with the ICIQ-FLUTS which is a questionnaire for evaluating female lower urinary tract symptoms and impact on quality of life of the patients.
Change in the Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS) scores at 18 months
Time frame: Change from baseline at 18 months
All patients (SUI and MUI) were evaluated with the ICIQ-FLUTS which is a questionnaire for evaluating female lower urinary tract symptoms and impact on quality of life of the patients.
Change in the Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS) scores at 24 months
Time frame: Change from baseline at 24 months
All patients (SUI and MUI) were evaluated with the ICIQ-FLUTS which is a questionnaire for evaluating female lower urinary tract symptoms and impact on quality of life of the patients.
Change in the Incontinence Quality of Life Scale (I-QOL) scores at 1 month
Time frame: Change from baseline at 1 month
All patients (SUI and MUI) were evaluated with the I-QOL which has 22 questions with the following 3 subscales: avoid and limiting behaviors (items), psychosocial impacts (9 items), and social embarassment (5 items).
Change in the Incontinence Quality of Life Scale (I-QOL) scores at 3 months
Time frame: Change from baseline at 3 months
All patients (SUI and MUI) were evaluated with the I-QOL which has 22 questions with the following 3 subscales: avoid and limiting behaviors (items), psychosocial impacts (9 items), and social embarassment (5 items).
Change in the Incontinence Quality of Life Scale (I-QOL) scores at 6 months
Time frame: Change from baseline at 6 months
All patients (SUI and MUI) were evaluated with the I-QOL which has 22 questions with the following 3 subscales: avoid and limiting behaviors (items), psychosocial impacts (9 items), and social embarassment (5 items).
Change in the Incontinence Quality of Life Scale (I-QOL) scores at 12 months
Time frame: Change from baseline at 12 months
All patients (SUI and MUI) were evaluated with the I-QOL which 22 questions with the following 3 subscales: avoid and limiting behaviors (items), psychosocial impacts (9 items), and social embarassment (5 items).
Change in the Incontinence Quality of Life Scale (I-QOL) scores at 18 months
Time frame: Change from baseline at 18 months
All patients (SUI and MUI) were evaluated with the I-QOL which has 22 questions with the following 3 subscales: avoid and limiting behaviors (items), psychosocial impacts (9 items), and social embarassment (5 items).
Change in the Incontinence Quality of Life Scale (I-QOL) scores at 24 months
Time frame: Change from baseline at 24 months
All patients (SUI and MUI) were evaluated with the I-QOL which has 22 questions with the following 3 subscales: avoid and limiting behaviors (items), psychosocial impacts (9 items), and social embarassment (5 items).
Need for addtional treatment within the 1st month
Time frame: Within the 1st month
Patients who are needed to treat with re-injection or other surgercal approaches.
Need for addtional treatment within 3 months after internvention.
Time frame: Within the 3 months after internvention.
Patients who are needed to treat with re-injection or other surgercal approaches.
Need for addtional treatment within 6 months after internvention.
Time frame: Within the 6 months after internvention.
Patients who are needed to treat with re-injection or other surgercal approaches.
Need for addtional treatment within 12 months after internvention.
Time frame: Within the 12 months after internvention.
Patients who are needed to treat with re-injection or other surgercal approaches.
Need for addtional treatment within 18 months after internvention.
Time frame: Within the 18 months after internvention.
Patients who are needed to treat with re-injection or other surgercal approaches.
Need for addtional treatment within 24 months after internvention.
Time frame: Within the 24 months after internvention.
Patients who are needed to treat with re-injection or other surgercal approaches.
Presence of complication within 24 months after intervention
Time frame: Within 24 months after intervention
Presence of complication such as infection at injection site, urinary tract infection, hematuria, persistent pain, de novo urge incontinence) in all patients.

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 23 Mar 2021.
Background: PubMed 31030824Irwin GM. Urinary Incontinence. Prim Care. 2019 Jun;46(2):233-242. doi: 10.1016/j.pop.2019.02.004. Epub 2019 Apr 5.
Background: PubMed 29067430Muth CC. Urinary Incontinence in Women. JAMA. 2017 Oct 24;318(16):1622. doi: 10.1001/jama.2017.15571. No abstract available.
Individual participant dataSharing planned: No. yes

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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.

İbrahim N Tahtali, MD principal investigator

Turgut Ozal University

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Periurethral injection and Hypertonic (10%) saline in people with Urinary Stress Incontinence, run by Turgut Ozal University at 2 sites in Turkey (Türkiye).

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 1 inclusion and 1 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 23 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Turkey (Türkiye). 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Change in the Stamey Incontinence Grade at 24 months (time frame: Change from baseline at 24 months). The study lists 26 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04812574, which also lists 2 linked publications.

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 23 Mar 2021.