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Completed

NCT Number: NCT04812574

Hypertonic Saline Injection For Urinary Incontinence

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.

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Key information

Conditions

Urinary Stress Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Turgut Ozal University, Malatya, Turkey (Türkiye)

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 (10%) saline

Drug

Periurethral hypertonic saline (10%)

Other names: 10% NaCl solution

Primary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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).

  15. 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).

  16. 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).

  17. 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).

  18. 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).

  19. 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).

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  24. 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.

  25. 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.

  26. 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.

Sponsors and collaborators

Lead sponsor

Turgut Ozal University

Other

Collaborators

  • Inonu University

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2018
Study completion
2020
First posted
Mar 23, 2021
Registry last updated
Mar 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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