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Hypertonic Saline Injection For Urinary Incontinence

Primary Purpose

Urinary Stress Incontinence

Status

Completed

Phase

Phase 3

Locations

Turkey

Study Type

Interventional

Intervention

Periurethral injection

Hypertonic (10%) saline

About this trial

This is an interventional treatment trial for Urinary Stress Incontinence focused on measuring Female, Stress Urinary Incontinence, Stress-Predominant Mixed Incontinence, Hypertonic Saline Injection, Therapy

Eligibility Criteria

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

Inclusion Criteria:

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.

Exclusion Criteria:

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

Sites / Locations

Turgut Ozal University
İnonu University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hypertonic Saline (10%) Injection

Arm Description

Periurethral hypertonic saline (10%) injection was performed in female patients with Stress Urinary Incontinence or Stress-Predominant Mixed Urinary Incontinence.

Outcomes

Primary Outcome Measures

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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).

Change in the Incontinence Quality of Life Scale (I-QOL) scores at 3 months

Change in the Incontinence Quality of Life Scale (I-QOL) scores 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).

Change in the Incontinence Quality of Life Scale (I-QOL) scores at 18 months

Change in the Incontinence Quality of Life Scale (I-QOL) scores at 24 months

Need for addtional treatment 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.

Patients who are needed to treat with re-injection or other surgercal approaches.

Need for addtional treatment within 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.

Patients who are needed to treat with re-injection or other surgercal approaches.

Need for addtional treatment within 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.

Patients who are needed to treat with re-injection or other surgercal approaches.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04812574

First Posted

February 4, 2021

Last Updated

March 19, 2021

Sponsor

Turgut Ozal University

Collaborators

Inonu University

1. Study Identification

Unique Protocol Identification Number

NCT04812574

Brief Title

Hypertonic Saline Injection For Urinary Incontinence

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

January 1, 2014 (Actual)

Primary Completion Date

April 1, 2018 (Actual)

Study Completion Date

June 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Turgut Ozal University

Collaborators

Inonu University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief 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.

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).

6. Conditions and Keywords

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

Urinary Stress Incontinence

Keywords

Female, Stress Urinary Incontinence, Stress-Predominant Mixed Incontinence, Hypertonic Saline Injection, Therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

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)

Allocation

N/A

Enrollment

65 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Hypertonic Saline (10%) Injection

Arm Type

Experimental

Arm Description

Periurethral hypertonic saline (10%) injection was performed in female patients with Stress Urinary Incontinence or Stress-Predominant Mixed Urinary Incontinence.

Intervention Type

Procedure

Intervention Name(s)

Periurethral injection

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Hypertonic (10%) saline

Other Intervention Name(s)

10% NaCl solution

Intervention Description

Periurethral hypertonic saline (10%)

Primary Outcome Measure Information:

Title

Change in the Stamey Incontinence Grade at 24 months

Description

Time Frame

Change from baseline at 24 months

Title

Change in the Urinary Distress Inventory-6 (UDI-6) scores at 1 month

Description

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.

Time Frame

Change from baseline at 1 month

Title

Change in the Urinary Distress Inventory-6 (UDI-6) scores at 3 months

Description

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.

Time Frame

Change from baseline at 3 months

Title

Change in the Urinary Distress Inventory-6 (UDI-6) scores at 6 months

Description

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.

Time Frame

Change from baseline at 6 months

Title

Change in the Urinary Distress Inventory-6 (UDI-6) at 12 months

Description

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.

Time Frame

Change from baseline at 12 months

Title

Change in the Urinary Distress Inventory-6 (UDI-6) scores at 18 months

Description

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.

Time Frame

Change from baseline 18 months

Title

Change in the Urinary Distress Inventory-6 (UDI-6) scores at 24 months

Description

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.

Time Frame

Change from baseline 24 months

Title

Change in the Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS) scores at 1 month

Description

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.

Time Frame

Change from baseline at 1 month

Title

Change in the Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS) scores at 3 months

Description

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.

Time Frame

Change from baseline at 3 months

Title

Change in the Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS) scores at 6 months

Description

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.

Time Frame

Change from baseline at 6 months

Title

Change in the Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS) scores at 12 months

Description

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.

Time Frame

Change from baseline at 12 months

Title

Change in the Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS) scores at 18 months

Description

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.

Time Frame

Change from baseline at 18 months

Title

Change in the Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS) scores at 24 months

Description

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.

Time Frame

Change from baseline at 24 months

Title

Change in the Incontinence Quality of Life Scale (I-QOL) scores at 1 month

Description

Time Frame

Change from baseline at 1 month

Title

Change in the Incontinence Quality of Life Scale (I-QOL) scores at 3 months

Description

Time Frame

Change from baseline at 3 months

Title

Change in the Incontinence Quality of Life Scale (I-QOL) scores at 6 months

Description

Time Frame

Change from baseline at 6 months

Title

Change in the Incontinence Quality of Life Scale (I-QOL) scores at 12 months

Description

Time Frame

Change from baseline at 12 months

Title

Change in the Incontinence Quality of Life Scale (I-QOL) scores at 18 months

Description

Time Frame

Change from baseline at 18 months

Title

Change in the Incontinence Quality of Life Scale (I-QOL) scores at 24 months

Description

Time Frame

Change from baseline at 24 months

Title

Need for addtional treatment within the 1st month

Description

Patients who are needed to treat with re-injection or other surgercal approaches.

Time Frame

Within the 1st month

Title

Need for addtional treatment within 3 months after internvention.

Description

Patients who are needed to treat with re-injection or other surgercal approaches.

Time Frame

Within the 3 months after internvention.

Title

Need for addtional treatment within 6 months after internvention.

Description

Patients who are needed to treat with re-injection or other surgercal approaches.

Time Frame

Within the 6 months after internvention.

Title

Need for addtional treatment within 12 months after internvention.

Description

Patients who are needed to treat with re-injection or other surgercal approaches.

Time Frame

Within the 12 months after internvention.

Title

Need for addtional treatment within 18 months after internvention.

Description

Patients who are needed to treat with re-injection or other surgercal approaches.

Time Frame

Within the 18 months after internvention.

Title

Need for addtional treatment within 24 months after internvention.

Description

Patients who are needed to treat with re-injection or other surgercal approaches.

Time Frame

Within the 24 months after internvention.

Title

Presence of complication within 24 months after intervention

Description

Presence of complication such as infection at injection site, urinary tract infection, hematuria, persistent pain, de novo urge incontinence) in all patients.

Time Frame

Within 24 months after intervention

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

İbrahim N Tahtali, MD

Organizational Affiliation

Turgut Ozal University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Turgut Ozal University

City

Malatya

ZIP/Postal Code

44100

Country

Turkey

Facility Name

İnonu University

City

Malatya

ZIP/Postal Code

44120

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

yes

Citations:

PubMed Identifier

31030824

Citation

Irwin GM. Urinary Incontinence. Prim Care. 2019 Jun;46(2):233-242. doi: 10.1016/j.pop.2019.02.004. Epub 2019 Apr 5.

Results Reference

background

PubMed Identifier

29067430

Citation

Muth CC. Urinary Incontinence in Women. JAMA. 2017 Oct 24;318(16):1622. doi: 10.1001/jama.2017.15571. No abstract available.

Results Reference

background

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Hypertonic Saline Injection For Urinary Incontinence

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