Home-Based Transcutaneous Remotely Monitored Posterior Tibial Neuromodulation System in Overactive Bladder: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- 3-Day Bladder Diary
研究概览
简要总结
To record the T-PTNS device (SmartUric) treatment performed by the patient at home via a mobile application in a remotely monitorable, secure and interactive manner with registration notes and a sham control group.
详细描述
-
Determination of candidate cases for the study
-
Conducting the eligibility assessment for the study according to the protocol (medical history, physical and urogynecological examination, USG, blood, urine analysis and/or culture tests if the researcher deems necessary)
-
Obtaining the informed consent form (VCF) from the cases who are found suitable and want to participate in the study
-
Creation of follow-up files specific to each patient in digital format and in hard copy for treatment follow-up.
-
Initial measurements will be made at the research center. The patient will be asked to fill out a three-day urinary diary, Overactive Bladder Assessment Form (OAB-V8) and International Incontinence Questionnaire-Short Form (ICIQ-UI-SF) for symptom and quality of life assessment. In addition, validated questionnaires such as Female Sexual Function Inventory-(FSFI) and Female Lower Urinary Tract Symptoms (ICIQ-FLUTS), Overactive Bladder Questionnaire-Short Form (OAB-q SF) given to the patient in hard copy will be used. These data will be taken as a starting point and recorded in the study follow-up files.
-
In order to provide and control T-PTNS usage training (The treatment will be applied by the patient at home), the researchers will provide training and sample application support to the patient until it is ensured that the patient can apply the treatment at home.
-
Start of 12-week T-PTNS treatment
-
The follow-up of treatment sessions can be monitored remotely by the researchers via the mobile application.
-
After the treatment session, the patient will be asked to complete the questionnaires included in the treatment follow-up (Three-day bladder diary, OAB-V8 and ICIQ-UI-SF) digitally from home via the mobile application.
-
The patients will be asked via phone in Weeks 2 or 3 which treatment group they think they are in and their answers will be recorded.
-
The patients who have completed their 12-session treatment will be invited to the hospital and will be asked to complete the Female Sexual Function Inventory (FSFI), Female Lower Urinary Tract Symptoms (ICIQ-FLUTS), Overactive Bladder Questionnaire-Short Form (OAB-q SF) forms given at the study center in addition to the surveys (OAB-V8, ICIQ-UI-SF, Three-day bladder diary) they completed via the mobile application.
-
According to the 12-week results;
-
Patients whose treatment was completed with the real device and who benefited will be switched to maintenance treatment at the same treatment dose and once a month for 9 months.
-
Patients who did not benefit in the sham treatment group will be given the real device and the same treatment procedure will be applied once a week, 30 minutes/session, for a total of 12 sessions. At the end of the 12 sessions, they will be called to the research center and the same evaluation procedure will be applied to the real device group. Patients who benefited in the sham group will be included in the 6-month maintenance treatment period. In the 3rd month maintenance treatment period, the interim evaluation will be made remotely via the mobile application.
-
Maintenance treatment will be monitored remotely in 3-month periods and the patients will fill out the digital questionnaires defined on the application every three months. The 3rd and 6th months will be repeated.
-
All patients who have completed their treatment will be called to the research center after one year of treatment and will be asked to complete the urinary diary and symptomatic questionnaire (OAB-V8 and ICIQ-UI_SF) evaluations as well as the Female Sexual Function Inventory-(FSFI), Female Lower Urinary Tract Symptoms (ICIQ-FLUTS), Overactive Bladder Questionnaire-Short Form (OAB-q SF) forms given in hard copy at the study center. At the same time, the researchers may call the patients who benefited after 12 sessions of sham treatment to the research center at the end of one year.
-
After all the evaluations, statistical analysis will be made at the end of the 12-week treatment and at the end of 1 year. In addition, if the researcher deems it appropriate, statistical analysis can be performed in the interim period (6 weeks, 3 months, 6 months).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patients who are ≥18 years old and female patients diagnosed with OAB* in Urology or Urogynecology outpatient clinics and who meet the inclusion criteria
- •Being able to continue their T-PTNS** treatment at home with the mobile application and accepting this,
- •Having a smartphone compatible with the application for T-PTNS and being able to use the application
- •Agreeing to be followed up for one year after treatment,
- •Having stopped all antimuscarinics for at least two weeks,
- •Being able to stand and use the toilet independently without difficulty,
- •Volunteers who are willing to participate, have been informed about the study and have given signed informed consent, stating that they can comply with the requirements and restrictions listed in the informed consent form (ICP) and this protocol.
排除标准
- •Patients under the age of 18
- •Patients who are pregnant according to the results of a pregnancy test with urine or blood test, or who are planning a pregnancy during the study period, or who are breastfeeding
- •Patients diagnosed with neurogenic bladder
- •Patients with Dabetes Mellitus whose blood sugar cannot be controlled
- •Patients with a history of allergic reactions on the skin
- •Cases with prolapse greater than Stage-2 according to the POP-Q staging system and extending beyond the hymen
- •Cases with a PVR evaluation of 100 ml and above with USG
- •Contraindications for T-PTNS treatment (patients with pacemakers, implantable defibrillators or metal prostheses
- •Patients with urinary tract infection*
- •Having had botox applied to the bladder or pelvic floor muscles within the last year
- •Having had a previous surgery related to the pelvic floor
- •Current TENS use in the pelvic region, back or legs
- •Having received PTNS treatment before
- •Use of Interstim or Bion
- •Those who do not accept the treatment or follow-up to be performed
- •Those who may have problems complying with the requirements of the study plan
- •Negative benefit/risk ratio determined by the investigator
- •Those who have been included in any other clinical trial or use of investigational drug/device therapy within 30 days before the study visit
研究组 & 干预措施
Test Device
T-PTNS treatment will be performed at home with an external generator and two surface electrode testers. Each T-PTNS session will consist of a test and treatment section. The treatment will be planned and carried out by the researchers.
Treatment dose is 1 day/week, 30 minutes/session, totaling 12 sessions. Treatment Pulse Frequency: 20 Hz, Treatment Pulse Width: 200us (microsecond).
干预措施: Efficacy of remotely monitored transcutaneous posterior tibial nerve neuromodulation via a test device at 12 week and 12 month (Device)
Sham Device
These are devices that have the same physical appearance, interface and feedback features, but are prepared in a way that they will not provide electrical stimulation during the treatment session. They are delivered to the CRO by the project manager and are randomized through the CRO and given to the researchers with a code. The duration and frequency of treatment will be the same as the treatment group.
干预措施: Efficacy of remotely monitored transcutaneous posterior tibial nerve neuromodulation via a placebo device at 12 week (Device)
结局指标
主要结局
3-Day Bladder Diary
时间窗: Baseline, 12th week, and 12th month
The 3-Day Bladder Diary is a structured patient-reported record used to evaluate urinary frequency, volume, fluid intake, urgency episodes, incontinence events, and nocturia across 3 consecutive days. Parameters recorded: * Time of each void * Voided volume (mL) * Fluid intake (time and volume) * Incontinence episodes (yes/no, with type if known) * Urgency (optional, often rated 0-3 or described qualitatively) * Nocturia episodes. At least 30% reduction in 24-hour urinary frequency or defined as at least a 50% reduction in the number of urgency sensations with or without incontinence and/or at least a 30% reduction in 24-hour urinary frequency via a urinary diary filled by the patient for three days.
次要结局
- Overactive Bladder Questionnaire (OAB-V8)(Baseline, 12th week, and 12th month)
- International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)(Baseline, 12th week, and 12th month)
- The Overactive Bladder Quality of Life Short-Form (OAB-q SF)(Baseline, 12th week, and 12th month)
- Female Sexual Function Index (FSFI)(Baseline, 12th week, and 12th month)
- Female Lower Urinary Tract Symptoms Long Form Module (ICIQ-FLUTS Long Form)(Baseline, 12th week, and 12th month)
研究者
Gokay Ozceltik
Associate Professor
Ege University