Acupuncture on Post-Stroke Overactive Bladder

Recruiting

Phase N/A Results N/A

Trial Description

This study evaluates the effect of acupuncture on post-stroke overactive bladder symptoms. Participants will be put into groups randomly and compared. There are two groups: traditional acupuncture and usual care. The ratio of group allocation is 1:1.

Detailed Description

Current practice in management of OAB is quite limited. Acupuncture, which is a major treatment modality of traditional Chinese medicine, has also claimed to have favourable therapeutic effect on OAB. Previous study found that acupuncture at the BL-33 point was effective for controlling the overactive bladder. Although acupuncture has been shown to be effective in treating OAB, there has been no randomized controlled trial examining the efficacy of acupuncture on patients with post-stroke. Given the high incidence of OAB in post-stroke patients, potentially effective alternative treatments should be investigated.

Conditions

Interventions

  • Usual care Other
    Intervention Desc: Patients will receive conventional rehabilitation as usual, including standard physiotherapy, bladder training and general advise of fluid intake.
    ARM 1: Kind: Experimental
    Label: Usual Care
    Description: Patients will receive conventional rehabilitation as usual, including standard physiotherapy, bladder training and general advise of fluid intake.
  • Traditional Acupuncture Other
    Intervention Desc: Treatment is based on the traditional Chinese medicine theory for treating overactive bladder. Qi-transforming function of bladder is regulated by experienced Chinese medicine practitioner.
    ARM 1: Kind: Experimental
    Label: Traditional Acupuncture
    Description: Acupoints which are empirical for treating OAB in terms of Traditional Chinese medicine theory are used (in the sequence of scalp reproduction area and motor area of the unaffected side, RN3, bilateral BL32, BL33, BL28, BL39). And Ear point urinary bladder, and Ear point uterus will be treated after removal of needles. Needles will be left for 30 minutes and then removed. Subjects will be treat with acupuncture 3 times per week for 3 weeks.
  • Placebo Acupuncture Other
    Intervention Desc: Subjects will be treated at non-acupoint and non-meridian site using non-invasive placebo acupuncture needles.
    ARM 1: Kind: Experimental
    Label: Placebo Acupuncture
    Description: Subjects will be treated at non-acupoint and non-meridian site using non-invasive placebo acupuncture needles. These needles sites should have no therapeutic effects according to the Traditional Chinese medicine theory. Needles will be left for 30 minutes and then removed. Subjects will be treat with acupuncture 3 times per week for 3 weeks.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Overactive Bladder Symptom Scale (OABSS) 1-week posttreatment No
Secondary Number of incontinent episodes measured by bladder diary 1-week posttreatment, 4-week posttreatment No
Secondary Stroke Specific Quality of Life Scale (SS-QoLS) 1-week posttreatment, 4-week posttreatment No
Secondary Medication measured by bladder diary 1-week posttreatment, 4-week posttreatment No

Sponsors