Second-generation Radiofrequency Application and Specific Therapeutic Exercise as a Treatment for Stress Urinary Incontinence Due to Urethral Instability. Randomised Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 239
- 试验地点
- 2
- 主要终点
- ultrasound analysis: Opening during exertion (Ae)
研究概览
简要总结
Stress urinary incontinence (SUI) is defined as the loss of the ability to hold urine after exertion, i.e., as a result of imbalances in intra-abdominal pressure, which directly affect the lower urinary tract. SUI has been shown to have a significant impact on the quality of life of those affected, impacting physical, social, and psycho-emotional aspects. Among the proposed treatments is a physiotherapeutic approach, which is offered as a less invasive and painless therapy with fewer adverse effects than pharmacological or surgical treatment. Pelvic floor muscle training (PFMT) is the most effective physiotherapeutic treatment for SUI, increasing the contractile capacity of the muscles and restoring stability throughout the pelvic diaphragm, thereby ensuring proper support of the pelvic organs. Radiofrequency (RF) therapy is currently being proposed as a therapeutic option that may offer certain advantages over those reported for photoplethysmography (PPMT). The potential benefits of RF therapy are attributed to its ability to stimulate collagen metabolism, thereby promoting tissue regeneration. Radiofrequency (RF) is a non-invasive and painless method that has the potential to yield analogous results to pelvic physical therapy (PPMT) as a standalone treatment or enhance the efficacy of PPMT when administered in conjunction with RF for stress urinary incontinence (SUI).
The objective of the present study is to analyse the effectiveness of PFMT and RF as single or combined treatments for SUI in women at Clínica Traña, a clinic specialising in the treatment of pelvic floor dysfunction in Costa Rica. Following the process of obtaining informed consent, patients will be offered a single or combined treatment of RF and/or PFMT. The strength of the pelvic floor muscles, pelvic function and the impact of pelvic dysfunctions on quality of life will be evaluated with a one-year follow-up after the conclusion of treatment.
The project possesses the facilities, equipment, and personnel necessary to ensure its viability, as well as proven clinical experience.
The scientific and technical impact of the proposed treatment protocol will be achieved by establishing an effective therapeutic strategy to address SUI. The social impact of SUI is significant, given its high prevalence and the fact that it has physical consequences as well as a negative impact on the social activities, work functions and emotions of women who suffer from it.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
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
- •Women over the age of 18 who meet the International Continence Society (ICS)
- •diagnostic criteria for SUI, which consists of involuntary leakage of urine during increased intra-abdominal pressure in the absence of bladder contractions such as coughing, sneezing, and other physical activities.
排除标准
- •diagnosis of urgent or mixed UI
- •diagnosis of pelvic organ prolapse
- •taking any treatment for UI
- •pregnancy
- •history of pelvic surgery, urinary tract infection, or diagnosed psychological disorders
- •presence of scars, malformations, abnormal pelvic masses, tissue irritation, or any other condition in the area that could be causing pelvic and urinary function problems
研究组 & 干预措施
RF Therapy
Participants will be placed in the lithotomy position. The treatment temperature will be set at 41°C, with a frequency of 1 MHz and power of 75 kJ. Once the indicated temperature has been reached, the physical therapist will perform small upward and downward movements along the urethral canal, dividing the time equally between both sides. One RF session will be performed every 7 days, as described by the author, for a total of 5 sessions. We divided the subjects into mild SUI (1-2 points in the Sandvik test); moderate SUI (Sandvik test of 3 to 6 points), severe SUI (8-9 points Sandvik test); and very severe SUI (12 points in Sandvik test).
干预措施: Short International Consultation on Incontinence Questionnaire (ICIQ-SF) (Diagnostic Test)
RF Therapy
Participants will be placed in the lithotomy position. The treatment temperature will be set at 41°C, with a frequency of 1 MHz and power of 75 kJ. Once the indicated temperature has been reached, the physical therapist will perform small upward and downward movements along the urethral canal, dividing the time equally between both sides. One RF session will be performed every 7 days, as described by the author, for a total of 5 sessions. We divided the subjects into mild SUI (1-2 points in the Sandvik test); moderate SUI (Sandvik test of 3 to 6 points), severe SUI (8-9 points Sandvik test); and very severe SUI (12 points in Sandvik test).
干预措施: King's Health Questionnaire (KHQ) (Diagnostic Test)
RF Therapy
Participants will be placed in the lithotomy position. The treatment temperature will be set at 41°C, with a frequency of 1 MHz and power of 75 kJ. Once the indicated temperature has been reached, the physical therapist will perform small upward and downward movements along the urethral canal, dividing the time equally between both sides. One RF session will be performed every 7 days, as described by the author, for a total of 5 sessions. We divided the subjects into mild SUI (1-2 points in the Sandvik test); moderate SUI (Sandvik test of 3 to 6 points), severe SUI (8-9 points Sandvik test); and very severe SUI (12 points in Sandvik test).
干预措施: Ultrasound evaluation (Diagnostic Test)
RF Therapy
Participants will be placed in the lithotomy position. The treatment temperature will be set at 41°C, with a frequency of 1 MHz and power of 75 kJ. Once the indicated temperature has been reached, the physical therapist will perform small upward and downward movements along the urethral canal, dividing the time equally between both sides. One RF session will be performed every 7 days, as described by the author, for a total of 5 sessions. We divided the subjects into mild SUI (1-2 points in the Sandvik test); moderate SUI (Sandvik test of 3 to 6 points), severe SUI (8-9 points Sandvik test); and very severe SUI (12 points in Sandvik test).
干预措施: Sandvik Severity Index (Diagnostic Test)
RF Therapy
Participants will be placed in the lithotomy position. The treatment temperature will be set at 41°C, with a frequency of 1 MHz and power of 75 kJ. Once the indicated temperature has been reached, the physical therapist will perform small upward and downward movements along the urethral canal, dividing the time equally between both sides. One RF session will be performed every 7 days, as described by the author, for a total of 5 sessions. We divided the subjects into mild SUI (1-2 points in the Sandvik test); moderate SUI (Sandvik test of 3 to 6 points), severe SUI (8-9 points Sandvik test); and very severe SUI (12 points in Sandvik test).
干预措施: Oxford's scale (Diagnostic Test)
RF Therapy
Participants will be placed in the lithotomy position. The treatment temperature will be set at 41°C, with a frequency of 1 MHz and power of 75 kJ. Once the indicated temperature has been reached, the physical therapist will perform small upward and downward movements along the urethral canal, dividing the time equally between both sides. One RF session will be performed every 7 days, as described by the author, for a total of 5 sessions. We divided the subjects into mild SUI (1-2 points in the Sandvik test); moderate SUI (Sandvik test of 3 to 6 points), severe SUI (8-9 points Sandvik test); and very severe SUI (12 points in Sandvik test).
干预措施: Biofeedback (Diagnostic Test)
Pelvic floor muscle training (PFMT)
The PFMT will consist of a targeted program with a protocol of core and pelvic floor exercises established based on an assessment of the patients' strength, endurance, and fatigue, with a frequency of twice a week led by a physical therapist and a duration of 45 minutes each day for a period of 16 weeks. It will be carried out in groups of 8 people and accompanied by a physical therapist experienced in therapeutic exercise. We divided the subjects into mild SUI (1-2 points in the Sandvik test); moderate SUI (Sandvik test of 3 to 6 points), severe SUI (8-9 points Sandvik test); and very severe SUI (12 points in Sandvik test).
干预措施: Short International Consultation on Incontinence Questionnaire (ICIQ-SF) (Diagnostic Test)
Pelvic floor muscle training (PFMT)
The PFMT will consist of a targeted program with a protocol of core and pelvic floor exercises established based on an assessment of the patients' strength, endurance, and fatigue, with a frequency of twice a week led by a physical therapist and a duration of 45 minutes each day for a period of 16 weeks. It will be carried out in groups of 8 people and accompanied by a physical therapist experienced in therapeutic exercise. We divided the subjects into mild SUI (1-2 points in the Sandvik test); moderate SUI (Sandvik test of 3 to 6 points), severe SUI (8-9 points Sandvik test); and very severe SUI (12 points in Sandvik test).
干预措施: King's Health Questionnaire (KHQ) (Diagnostic Test)
Pelvic floor muscle training (PFMT)
The PFMT will consist of a targeted program with a protocol of core and pelvic floor exercises established based on an assessment of the patients' strength, endurance, and fatigue, with a frequency of twice a week led by a physical therapist and a duration of 45 minutes each day for a period of 16 weeks. It will be carried out in groups of 8 people and accompanied by a physical therapist experienced in therapeutic exercise. We divided the subjects into mild SUI (1-2 points in the Sandvik test); moderate SUI (Sandvik test of 3 to 6 points), severe SUI (8-9 points Sandvik test); and very severe SUI (12 points in Sandvik test).
干预措施: Ultrasound evaluation (Diagnostic Test)
Pelvic floor muscle training (PFMT)
The PFMT will consist of a targeted program with a protocol of core and pelvic floor exercises established based on an assessment of the patients' strength, endurance, and fatigue, with a frequency of twice a week led by a physical therapist and a duration of 45 minutes each day for a period of 16 weeks. It will be carried out in groups of 8 people and accompanied by a physical therapist experienced in therapeutic exercise. We divided the subjects into mild SUI (1-2 points in the Sandvik test); moderate SUI (Sandvik test of 3 to 6 points), severe SUI (8-9 points Sandvik test); and very severe SUI (12 points in Sandvik test).
干预措施: Sandvik Severity Index (Diagnostic Test)
Pelvic floor muscle training (PFMT)
The PFMT will consist of a targeted program with a protocol of core and pelvic floor exercises established based on an assessment of the patients' strength, endurance, and fatigue, with a frequency of twice a week led by a physical therapist and a duration of 45 minutes each day for a period of 16 weeks. It will be carried out in groups of 8 people and accompanied by a physical therapist experienced in therapeutic exercise. We divided the subjects into mild SUI (1-2 points in the Sandvik test); moderate SUI (Sandvik test of 3 to 6 points), severe SUI (8-9 points Sandvik test); and very severe SUI (12 points in Sandvik test).
干预措施: Oxford's scale (Diagnostic Test)
Pelvic floor muscle training (PFMT)
The PFMT will consist of a targeted program with a protocol of core and pelvic floor exercises established based on an assessment of the patients' strength, endurance, and fatigue, with a frequency of twice a week led by a physical therapist and a duration of 45 minutes each day for a period of 16 weeks. It will be carried out in groups of 8 people and accompanied by a physical therapist experienced in therapeutic exercise. We divided the subjects into mild SUI (1-2 points in the Sandvik test); moderate SUI (Sandvik test of 3 to 6 points), severe SUI (8-9 points Sandvik test); and very severe SUI (12 points in Sandvik test).
干预措施: Biofeedback (Diagnostic Test)
combination of RF Therapy and PFMT
We divided the subjects into mild SUI (1-2 points in the Sandvik test); moderate SUI (Sandvik test of 3 to 6 points), severe SUI (8-9 points Sandvik test); and very severe SUI (12 points in Sandvik test).
干预措施: Short International Consultation on Incontinence Questionnaire (ICIQ-SF) (Diagnostic Test)
combination of RF Therapy and PFMT
We divided the subjects into mild SUI (1-2 points in the Sandvik test); moderate SUI (Sandvik test of 3 to 6 points), severe SUI (8-9 points Sandvik test); and very severe SUI (12 points in Sandvik test).
干预措施: King's Health Questionnaire (KHQ) (Diagnostic Test)
combination of RF Therapy and PFMT
We divided the subjects into mild SUI (1-2 points in the Sandvik test); moderate SUI (Sandvik test of 3 to 6 points), severe SUI (8-9 points Sandvik test); and very severe SUI (12 points in Sandvik test).
干预措施: Ultrasound evaluation (Diagnostic Test)
combination of RF Therapy and PFMT
We divided the subjects into mild SUI (1-2 points in the Sandvik test); moderate SUI (Sandvik test of 3 to 6 points), severe SUI (8-9 points Sandvik test); and very severe SUI (12 points in Sandvik test).
干预措施: Sandvik Severity Index (Diagnostic Test)
combination of RF Therapy and PFMT
We divided the subjects into mild SUI (1-2 points in the Sandvik test); moderate SUI (Sandvik test of 3 to 6 points), severe SUI (8-9 points Sandvik test); and very severe SUI (12 points in Sandvik test).
干预措施: Oxford's scale (Diagnostic Test)
combination of RF Therapy and PFMT
We divided the subjects into mild SUI (1-2 points in the Sandvik test); moderate SUI (Sandvik test of 3 to 6 points), severe SUI (8-9 points Sandvik test); and very severe SUI (12 points in Sandvik test).
干预措施: Biofeedback (Diagnostic Test)
结局指标
主要结局
ultrasound analysis: Opening during exertion (Ae)
时间窗: baseline
degrees
International Consultation on Incontinence Questionnaire (ICIQ-SF)
时间窗: baseline
0 to 21 points, where higher scores indicate greater impact of incontinence
King´s Health Questionnaire (KHQ)
时间窗: baseline
0 to 100, where 0 indicates the best quality of life and 100 the worst
ultrasound analysis: Resting aperture (Ar)
时间窗: baseline
degrees
King´s Health Questionnaire (KHQ)
时间窗: Pre - post intervention; after 3,6,12 months
0 to 100, where 0 indicates the best quality of life and 100 the worst
International Consultation on Incontinence Questionnaire (ICIQ-SF)
时间窗: Pre - post intervention; after 3,6,12 months
0 to 21 points, where higher scores indicate greater impact of incontinence
ultrasound analysis: Resting aperture (Ar)
时间窗: Pre - post intervention; after 3,6,12 months
degrees
ultrasound analysis: Opening during exertion (Ae)
时间窗: Pre - post intervention; after 3,6,12 months
degrees
Opening difference (Ae-Ar)
时间窗: Pre - post intervention; after 3,6,12 months
degrees
MUSCULAR STRENGTH
时间窗: Pre - post intervention; after 3,6,12 months
defined as the ability of tissue to generate tension based on its contractile capacity, being the best of three attempts to contract, assessed using the modified OXFORD scale
Function of the pelvic floor muscles
时间窗: Pre - post intervention; after 3,6,12 months
The best of the three attempts is selected, graded as follows: 0 = no contraction, 1 = partial contraction, 2 = contraction of the pelvic floor muscles + contraction of related muscles, 3 = isolated contraction of the Pelvic floor muscles
STATIC MUSCLE STRENGTH
时间窗: Pre - post intervention; after 3,6,12 months
the ability to maintain optimal contraction (isometric, tonic fibers) for as long as possible, measuring the seconds until fatigue sets in. ORDER: "contract and hold," taking the average of the three assessments.
Fatigability or Dynamic Endurance
时间窗: Pre - post intervention; after 3,6,12 months
maximum number of contractions in a unit of time, taking 10 seconds as the average. ORDER: "contract as many times as possible and at the highest speed," with the measurement being the average of the three assessments.
Oxford's Scale
时间窗: Pre - post intervention; after 3,6,12 months
allows the contractile capacity of the pelvic floor muscles to be assessed. It scores from 0 to 5, as follows: if there is no contraction, it is scored as 0; if the contraction is very weak, it is scored as 1; if the contraction is weak, it is scored as 2; if the contraction is moderate/with tension/and sustained, it is scored as 3; if the contraction is good and maintains tension with resistance, it is scored as 4; and if the contraction is strong and maintains tension against a resistant force, it is scored as 5.
Sandvik Severity Index
时间窗: Pre - post intervention; after 3,6,12 months
It allows the severity of UI to be determined based on two questions. Interpretation based on the score is classified as follows: 1-2 mild UI, 3-6 moderate UI, 8-9 severe UI, 12 very severe UI.
次要结局
- abortion(baseline)
- age (years)(baseline)
- BMI (Body mass index)(baseline)
- smoke(baseline)
- alcohol consumption(baseline)
- drug use(baseline)
- full-term pregnancies(baseline)
- natural childbirth(baseline)
- cesarean sections(baseline)
- tear(baseline)
- episiotomy(baseline)
研究者
SERGIO MONTERO NAVARRO
Clinical Professor
Cardenal Herrera University