Urinary Stress Incontinence
Conditions
Keywords
Female, Stress Urinary Incontinence, Stress-Predominant Mixed Incontinence, Hypertonic Saline Injection, Therapy
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).
Interventions
PROCEDUREPeriurethral injection
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.
DRUGHypertonic (10%) saline
Periurethral hypertonic saline (10%)
Sponsors
Inonu University
Turgut Ozal University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Stamey Incontinence Grade at 24 months | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. | 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. | 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. | 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. | 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. | 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 | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed