Diseases of the urogenital system
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Lower urinary tract symptoms occur( Frequent urination: urinary frequency >= 8 times/day, the average urine output per visit is less than 200ml;Increased nocturia: nocturia >=2 times/day; urinary incontinence; fecal incontinence); 2.The patient is over 18 years old; 3.The patient is proficient in using smartphones and is willing to accept digital bladder management/electronic urination diary; 4. After enrollment, agree to follow doctor's orders for follow-up visits/medication during the trial period; 5.Voluntarily participate in this clinical study and be able to sign the informed consent form
Exclusion criteria
Exclusion criteria: 1.Patients with poor compliance and missing follow-up data; 2.There are other specialized diseases that need to be treated in the pelvic cavity and related areas, such as bladder cancer, prostate cancer, cervical cancer, and other tumors of the urogenital system, tumors/injuries of the nervous system, uncontrolled urinary tract infections, etc; 3.Pregnant and lactating women, as well as women of childbearing age who plan to conceive during the study period; 4.Those with mental or cognitive impairments who are unable to complete this study; 5.There are contraindications related to the administration of the trial drug; 6.Other health conditions that the researchers consider unsuitable for participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| At the 3-month follow-up after enrollment, the improvement of the lower urinary tract symptom scale score in the subjects who received Xiaoyu Bladder Management System treatment/standard behavioral therapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of urination;Nocturia frequency;scores of ICIQ-MLUTS, ICIQ-FLUTS;Bristol stool classification;Scores of ICIQ-LUTSQoL; | — |
Countries
China
Contacts
Sun Yat-sen Memorial Hospital of Sun Yat-sen University