Skip to content

Pre-market clinical study of General Stim, Inc. pelvic floor rehabilitation apparatus

A prospective, multi-center, single-blinded, randomized controlled trial evaluating the safety and effectiveness of the pelvic floor rehabilitation apparatus in treating the underactive bladder

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900025475
Enrollment
Unknown
Registered
2019-08-27
Start date
2017-10-01
Completion date
Unknown
Last updated
2019-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Underactive bladder

Interventions

Experimental group:Adopt IVES conventional electrical stimulation treatment
Control group :Adopt IVES no-stimulation treatment. During the treatment, the disconnected stimulating electrode will be used to ensure no generation loop between the electrode and main machine, thus

Sponsors

China Rehabilitation Research Center, Beijing Boai Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Patients aged 18 to 70 years old; (2) Patients who have been diagnosed with UAB and have a disease duration greater than 3 months; (3) Patients with intermittent catheterization to empty the bladder, or indications of intermittent catheterization (residual urine volume accounts for more than 40% of functional bladder capacity); (4) Patients who voluntarily signed written informed consent; (5) Patients who are able to communicate well with the researchers and are willing to adhere to the research protocols.

Exclusion criteria

Exclusion criteria: (1) Patients with low bladder compliance (less than 20 ml/cmH2O) in urodynamic tests; (2) Patients with mechanical obstruction of the outflow tract; (3) Patients with complete spinal cord injury; (4) Patients with symptomatic urinary tract infections; (5) Patients with hydronephrosis or vesicoureteral reflux; (6) Patients with renal insufficiency (the serum creatinine is higher than 1.5 times the upper limit); (7) Patients with bladder and prostate cancers: (8) Patients with implanted pacemakers or defibrillators; (9) Patients with Alzheimer's disease, brain atrophy, acute phase of cerebrovascular disease, cognitive impairment; (10) Patients with epilepsy, mental illness and patients who cannot cooperate with doctors; (11) Patients with positive preoperative infectious disease screening (hepatitis B surface antigen, hepatitis C antibody, syphilis antibody and HIV antibody); (12) Pregnant women or patients ready to be pregnant; (13) Patients who have participated in other clinical trials 3 months before; (14) Other circumstances that the investigators believe are inappropriate for participation in the study.

Design outcomes

Primary

MeasureTime frame
Change in the residual urine volume;

Secondary

MeasureTime frame
Maximum urine flow;Bladder voiding efficiency;Frequency of intermittent catheterization;Number of patients with complete disengagement from intermittent catheterization;PPBC-S score;AUA-SI score;AUA-SI-QOL score;

Countries

China

Contacts

Public ContactLimin Liao

China Rehabilitation Research Center, Beijing Boai Hospital

lmliao@163.com+86 13311268064

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026