Periurethral Hypertonic Saline (10%) Injection for Female Stress Urinary Incontinence and Stress-Predominant Mixed Urinary Incontinence
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Change in the Urinary Distress Inventory-6 (UDI-6) scores at 3 months
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Hypertonic Saline (10%) Injection
Periurethral hypertonic saline (10%) injection was performed in female patients with Stress Urinary Incontinence or Stress-Predominant Mixed Urinary Incontinence.
干预措施: Periurethral injection (Procedure)
Hypertonic Saline (10%) Injection
Periurethral hypertonic saline (10%) injection was performed in female patients with Stress Urinary Incontinence or Stress-Predominant Mixed Urinary Incontinence.
干预措施: Hypertonic (10%) saline (Drug)
结局指标
主要结局
Change in the Urinary Distress Inventory-6 (UDI-6) scores at 3 months
时间窗: 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 Stamey Incontinence Grade at 24 months
时间窗: 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 18 months
时间窗: 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
时间窗: 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 24 months
时间窗: 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 3 months
时间窗: 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 Urinary Distress Inventory-6 (UDI-6) scores at 1 month
时间窗: 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) at 12 months
时间窗: 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 Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS) scores at 18 months
时间窗: 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 Quality of Life Scale (I-QOL) scores at 24 months
时间窗: 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 6 months after internvention.
时间窗: Within the 6 months after internvention.
Patients who are needed to treat with re-injection or other surgercal approaches.
Change in the Urinary Distress Inventory-6 (UDI-6) scores at 6 months
时间窗: 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 Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS) scores at 1 month
时间窗: 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
时间窗: 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 Quality of Life Scale (I-QOL) scores at 6 months
时间窗: 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 18 months
时间窗: 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).
Need for addtional treatment within 3 months after internvention.
时间窗: Within the 3 months after internvention.
Patients who are needed to treat with re-injection or other surgercal approaches.
Change in the Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS) scores at 6 months
时间窗: 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
时间窗: 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 Quality of Life Scale (I-QOL) scores at 1 month
时间窗: 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).
Need for addtional treatment within 12 months after internvention.
时间窗: Within the 12 months after internvention.
Patients who are needed to treat with re-injection or other surgercal approaches.
Presence of complication within 24 months after intervention
时间窗: 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.
Change in the Incontinence Quality of Life Scale (I-QOL) scores at 12 months
时间窗: 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).
Need for addtional treatment within 24 months after internvention.
时间窗: Within the 24 months after internvention.
Patients who are needed to treat with re-injection or other surgercal approaches.
Need for addtional treatment within the 1st month
时间窗: Within the 1st month
Patients who are needed to treat with re-injection or other surgercal approaches.
Need for addtional treatment within 18 months after internvention.
时间窗: Within the 18 months after internvention.
Patients who are needed to treat with re-injection or other surgercal approaches.
次要结局
未报告次要终点
研究者
Ibrahim Nuvit Tahtali
Principal Investigator
Turgut Ozal University