Stress Urinary Incontinence
Conditions
Interventions
Case series:Patients with relatively stable symptoms of urinary incontinence will be implanted with the NuStim intervention to activate the nerve stimulation
Sponsors
China Rehabilitation Research Center, Beijing Boai Hospital
Eligibility
Sex/Gender
All
Age
35 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Clinically symptomatic female patients with mild-to-moderate stress urinary incontinence (SUI) more than 6 months and male patients with post-prostatectomy SUI more than 1 year and with PSA<1.0ng/ml, both aged between 35 to 75 years old; 2) Patients with ineffective conventional noninvasive treatment and are considered suitable for Nustim system training; 3) Patients with voluntary participation in the study and with the informed consent signed by the patients or their legal guardians; 4) Patients who are able to communicate well with the researchers and with good adherence to the research protocols.
Exclusion criteria
Exclusion criteria: 1) Patients with a history of spinal cord injury, spinal cord dysplasia, etc.; 2) Patients with overactive bladder; 3) Patients with symptomatic urinary tract infections; 4) Patients with urinary incontinence who have undergone other surgical procedures (except prostatectomy) but have not recovered; 5) Patients with urethral stricture after male prostatectomy (residual urine volume greater than 100ml); 6) Patients with type III stress urinary incontinence caused by urethral muscular defects; 7) Patients with a history of neurodegenerative diseases and neuromuscular disorders; 8) Female patients with malignant pelvic organs, history of ovarian tumors, and gynecological benign tumors; 9) Patients with congenital perineal malformation or severe perineal trauma not associated with delivery; 10) Patients who have undergone bladder surgery for fecal incontinence surgery or fistula treatment, and can be sure that such surgery is associated with urinary incontinence; 11) Patients with coagulopathy; 12) Patients with immune system disorders; 13) Pregnant women, breast feeding women, or women having pregnancy plan during the study period; 14) Patients with epilepsy; 15) Patients with heart disease and acute infectious diseases; 16) patients with fever and abnormal blood pressure; 17) Patients with senile dementia, brain atrophy, acute phase of cerebrovascular disease, or patients with sequelae and cognitive impairment; 18) Patients with local or systemic bacterial infections that are not effectively controlled in the acute phase; 19) Patients in shock and severe disease who cannot be evaluated and cooperate with the operation; 20) Patients with mental and neurological disorders who cannot cooperate with the doctors; 21) Patients with constipation; 22) Women who have not given birth; 23) People with atopy and scar physique; 24) Patients who have participated in other clinical trials 3 months before the trial; 25) Patients who intend to change their daily behavioral habits and lifestyle during the trial; 26) Other circumstances that the investigators believe are inappropriate for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes of the 1-hour urinal pad test in the urinal pad weight at the end of 13-week, as compared to the baseline period ;Changes of the 24-hour urinal pad test in the frequency of urinal pad replacement and pad weight at the end of 13-week, as compared to the baseline period ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in the respondent’s quality of life and life satisfaction degree (measured by the quality of life questionnaire) at the end of 1 week, 3 weeks, 8 weeks and 13 weeks, compared with the base line period;Changes in the bladder diary of the respondents at the end of 1 week, 3 weeks, 8 weeks and 13 weeks (average 24-hour urination frequency, volume per void , urgency score, average 24-hour urine leakage improvement), compared with the base li;Changes in abdominal leak point pressure (ALPP includes VLPP and CLPP) in urine dynamics at the end of 8 weeks, 13 weeks/25 weeks, compared with the baseline;Changes in urethral pressure distribution profile inspection (UPP includes MUP and MUCP) at the end of 8 weeks, 13 weeks/25 weeks, compared with the baseline;Changes in the Patient Perception of Bladder Condition (PPBC) score at the end of the 13th week, compared to baseline ;Changes in pelvic floor electrophysiological tests at the end of 13 weeks/25 weeks, compared to baseline;Changes in the pelvic floor muscle strength score at the end of 13 weeks/25 weeks, compared to baseline;Changes of the 24-hour urinal pad test in urinal pad replacement frequency and weight at the end of 1 week, 3 weeks and 8 weeks, compared with the baseline in; | — |
Countries
China
Contacts
Public ContactLimin Liao
China Rehabilitation Research Center, Beijing Boai Hospital
Outcome results
None listed