Hypertonic Saline Injection For Urinary Incontinence

NCT04812574 | Completed Phase 3

• 1 other identifier: 6175679-514.04.01-E.28641
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 2

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.

Conditions

Urinary Stress Incontinence

Keywords

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

Outcome Measures

Primary Outcomes (26)

• 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 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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).

  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).

  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).

  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).

  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).

  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).

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  Within 24 months after intervention

Study Arms (1)

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.

Procedure: Periurethral injection; Drug: Hypertonic (10%) saline

Interventions

Periurethral injection PROCEDURE

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 Saline (10%) Injection

Hypertonic (10%) saline DRUG

Periurethral hypertonic saline (10%)

Also known as: 10% NaCl solution

Hypertonic Saline (10%) Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Turgut Ozal University: lead
• Inonu University: collaborator

Study Sites (2)

Turgut Ozal University

Malatya, 44100, Turkey (Türkiye)

Location

İnonu University

Malatya, 44120, Turkey (Türkiye)

Location

Related Publications (2)

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

  PMID: 31030824 BACKGROUND

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

  PMID: 29067430 BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

Sodium Chloride

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

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• İbrahim N Tahtali, MD

  Turgut Ozal University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: February 4, 2021
• First Posted: March 23, 2021
• Study Start: January 1, 2014
• Primary Completion: April 1, 2018
• Study Completion: June 1, 2020
• Last Updated: March 23, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)