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.
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
65
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.
Periurethral hypertonic saline (10%)
Turgut Ozal University
Malatya, Turkey (Türkiye)
İnonu University
Malatya, Turkey (Türkiye)
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Within 24 months after intervention