Acupuncture for Overactive Bladder in Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-08

Study Completion Date

2024-12-31

Brief Summary

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The purpose of this study is to assess the effectiveness and safety of acupuncture for treating overactive bladder in adults.

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Detailed Description

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This randomized, controlled trial is aimed to assess the effectiveness and safety of acupuncture in the treatment of overactive bladder (OAB) in adults. Eligible participants will be randomly allocated to acupuncture or sham acupuncture.

To minimize the evaluation bias, the outcome assessors and statisticians will be masked to treatment allocation besides participants.

Conditions

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Overactive Bladder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Acupuncture

Participants will receive acupuncture.

Group Type EXPERIMENTAL

Acupuncture

Intervention Type OTHER

Participants will receive acupuncture, three times per week for eight weeks. The selected acupoints include bilateral BL33, BL35, SP6, and ST36. All acupoints areas have been sterilized before acupuncture. For BL33, a needle (Ф0.40×100mm) will be inserted with an angle of 60° in an inferomedial direction at a depth of 90-100mm. For BL35, the same needle will be inserted with a direction to the ischial rectal fossa at a depth of 60-70 mm deep. For SP6 and ST36, needles (Ф0.30×50mm) will be directly inserted at a depth of 25-30 mm deep. After the needles are inserted, a portable electro-acupuncture machine will be connected to the handles of needles located in BL33 and BL35 to provide the electrical stimulation for 30 minutes with a disperse-dense wave (4/20Hz). All current intensities will be as high as can be tolerated.

Sham acupuncture

Participants will receive sham acupuncture.

Group Type SHAM_COMPARATOR

Sham acupuncture

Intervention Type OTHER

The sham acupoints will be located at 20 mm outward to BL33, BL35, SP6, and ST36, and the needless will be inserted with a depth of 2 mm. The BL33 and BL35 will not receive any electrical stimulation, though the handles of needles will be connected to the same machine as the acupuncture group, and the parameter setting and course are also the same.

Interventions

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Acupuncture

Participants will receive acupuncture, three times per week for eight weeks. The selected acupoints include bilateral BL33, BL35, SP6, and ST36. All acupoints areas have been sterilized before acupuncture. For BL33, a needle (Ф0.40×100mm) will be inserted with an angle of 60° in an inferomedial direction at a depth of 90-100mm. For BL35, the same needle will be inserted with a direction to the ischial rectal fossa at a depth of 60-70 mm deep. For SP6 and ST36, needles (Ф0.30×50mm) will be directly inserted at a depth of 25-30 mm deep. After the needles are inserted, a portable electro-acupuncture machine will be connected to the handles of needles located in BL33 and BL35 to provide the electrical stimulation for 30 minutes with a disperse-dense wave (4/20Hz). All current intensities will be as high as can be tolerated.

Intervention Type OTHER

Sham acupuncture

The sham acupoints will be located at 20 mm outward to BL33, BL35, SP6, and ST36, and the needless will be inserted with a depth of 2 mm. The BL33 and BL35 will not receive any electrical stimulation, though the handles of needles will be connected to the same machine as the acupuncture group, and the parameter setting and course are also the same.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Present symptoms of urinary frequency and urgency for more than 3 months.
* With a total score of more than 3 points on the overactive Bladder Symptom Score (OABSS) and a score of more than 2 points on question 3 of OABSS.

Exclusion Criteria

* With other lower urinary tract disorders (e.g. urinary tract infection, bladder outlet obstruction, neurogenic bladder, interstitial cystitis, etc.)
* With previous pelvic floor surgery or a post-void residual urine volume more than 100 mL.
* With neurological disease or psychiatric illness.
* Taking medications affecting lower urinary tract function.
* With contraindications to acupuncture.
* Pregnant women.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No