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Efficacy of Different Electrical Stimulation Placement in Patients With Overactive Bladder Syndrome

C

Chung Shan Medical University

Status

Unknown

Conditions

Overactive Bladder Syndrome

Treatments

Device: Intravaginal electrical stimulation
Device: Parasacral transcutaneous electrical stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT03516435
CS17150

Details and patient eligibility

About

This experiment is expected to understand the benefits of different settings of electrical stimulation in the treatment of overactive bladder.

Full description

This experiment is expected to understand the benefits of different settings of electrical stimulation in the treatment of overactive bladder.The study will adopt a longitudinal research design with randomized quasi-experimental trial.The patients will recruited and be randomly assigned to Group A (Parasacral transcutaneous electrical stimulation) or Group B (Intravaginal electrical stimulation). There will be 30 participants in each group. Data will be collected 2 times.

Enrollment

30 estimated patients

Sex

Female

Ages

20+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Urinary incontinence due to detrusor overactivity
  • No patients had been taking anticholinergics or tricyclic depressants and none had been treated by pelvic floor exercise, bladder training, or pelvic surgery before entry into the study.

Exclusion criteria

  • stress incontinence
  • urinary tract infection
  • neurological disease
  • genital prolapse higher than stage II on POP-Q system
  • pregnancy
  • diabetes mellitus
  • a history of anti-incontinence surgery and/or prolapse repair
  • pelvic tumors and previously treated with radiation therapy or antimuscarinic agents
  • patients who were not cooperative
  • electrical stimulation contraindications

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

30 participants in 2 patient groups

Parasacral transcutaneous ES
Experimental group
Description:
20min./session, 2 sessions/week ,12 sessions of Parasacral transcutaneous electrical stimulation.
Treatment:
Device: Parasacral transcutaneous electrical stimulation
Intravaginal electrical stimulation
Active Comparator group
Description:
20min./session, 2 sessions/week ,12 sessions of Intravaginal electrical stimulation.
Treatment:
Device: Intravaginal electrical stimulation

Trial contacts and locations

1

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Central trial contact

Chen Gin-Den, PhD; Chen Yi-Ching, MS

Data sourced from clinicaltrials.gov

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