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Completed

NCT Number: NCT02568774

Acupuncture on Post-Stroke Overactive Bladder

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai TCM-INTEGRATED Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chinese aged 18 or above
  • Patient suffering from first ever stroke or recurrent stroke with no urinary symptom in previous episode(s);
  • Patient with classic symptoms, i.e. urgency, urinary frequency or urge incontinence and Overactive Bladder Symptom Score (OABSS) score ≥3 and the urgency item rated as at least 2-point;
  • Not taking any medication for OAB
  • Able to communicate
  • No current acupuncture or transcutaneous electrical nerve stimulation treatment

Exclusion criteria

  • Urinary retention with post-void urinary volume > 100ml;
  • Current urinary tract infection;
  • Preexisting history of OAB or bladder outlet obstruction or underactive bladder;
  • Significant cognitive impairment with MMSE < or =19;
  • Coexisting Alzheimer's disease, Parkinson's disease, spinal cord disorder or progressive neurological disease such as multiple sclerosis;
  • Active skin lesion or open wound over the needle placement areas;
  • Having valvular heart defects, severe cardiac diseases, or bleeding disorders,
  • Being fitted with any implanted electrical device such as pacemaker, defibrillator, or brain stimulation;
  • Pregnant;
  • Malignancies at the sites of selected acupoints;
  • Receiving acupuncture treatment 1 month before baseline.

Treatment and study plan

Traditional Acupuncture

Other

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.

Usual Care

Other

Patients will receive conventional rehabilitation as usual, including standard physiotherapy, bladder training and general advise of fluid intake.

Primary outcomes

  1. Overactive Bladder Symptom Scale (OABSS)

    Time frame: 1-week posttreatment

    four item questionnaire quantifies overactive bladder symptoms in a single score

Secondary outcomes

  1. Number of incontinent episodes measured by bladder diary

    Time frame: 1-week posttreatment, 4-week posttreatment

    Record the frequency of day and night time voiding and incontinence episodes over 3 day periods

  2. Stroke Specific Quality of Life Scale (SS-QoLS)

    Time frame: 1-week posttreatment, 4-week posttreatment

    12 items questionnaire consists of physical and psychosocial subscales: amount of help required completing a task, trouble experienced performing a task and functioning.

  3. Medication measured by bladder diary

    Time frame: 1-week posttreatment, 4-week posttreatment

    number of patients requested medication for OAB from bladder diary.

Other outcomes

  1. AE measured by open-ended questions

    Time frame: first week of treatment, second week of treatment, third week of treatment, 1-week posttreatment, 4-week posttreatment

    open-ended questions about the experience of adverse events

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

Acupuncture on Post-Stroke Overactive Bladder: A Randomized Controlled Trial

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Oct 6, 2015
Registry last updated
Oct 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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