Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess the effectiveness and safety of acupuncture for treating overactive bladder in adults.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture | Experimental | Participants will receive acupuncture. |
|
| Sham acupuncture | Sham Comparator | Participants will receive sham acupuncture. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in number of micturition episodes per 24 hours | Assessed by 72 h bladder diary | Before treatment (baseline), 8 week (post-treatment) and 12 week (follow-up) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of urinary urgency episodes per 24 hours | Assessed by 72 h bladder diary | Before treatment (baseline), 8 week (post-treatment) and 12 week (follow-up) |
| Number of daytime micturition episodes per 24 hours |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ran Pang, MD | Contact | +8610-88001040 | pangran2002@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Ran Pang, MD | Guang'anmen hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guang'anmen Hospital, China Academy of Chinese Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100053 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36148895 | Derived | Hargreaves E, Baker K, Barry G, Harding C, Zhang Y, Kandala NB, Zhang X, Kernohan A, Clarkson CE. Acupuncture for treating overactive bladder in adults. Cochrane Database Syst Rev. 2022 Sep 23;9(9):CD013519. doi: 10.1002/14651858.CD013519.pub2. |
Not provided
Not provided
The agreement for sharing IPD is not designed to be signed in informed consent form.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Sham acupuncture | 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. |
|
Assessed by 72 h bladder diary
| Before treatment (baseline), 8 week (post-treatment) and 12 week (follow-up) |
| Number of nocturia episodes per 24 hours | Assessed by 72 h bladder diary | Before treatment (baseline), 8 week (post-treatment) and 12 week (follow-up) |
| Change in mean volume voided per micturition | Assessed by 72 h bladder diary | Before treatment (baseline), 8 week (post-treatment) and 12 week (follow-up) |
| Change in OABSS questionnaire | Assessed by Overactive Bladder Symptom Score (OABSS) questionnaire. OABSS includes 4 questions about individual symptoms, and the total score ranged from 0 to 15, with higher scores indicating more severe symptoms. The minimal important difference (MID) for the OABSS is 3 points. | Before treatment (baseline), 8 week (post-treatment) and 12 week (follow-up) |
| Change in OAB-q SF questionnaire | Assessed by overactive bladder questionnaire short form (OAB-q SF) questionnaire. OAB-q SF includes 6 questions on 6-point Likert-type scales, with the outcomes transformed to a 0-100 point scale in which higher scores indicate more severe symptoms. The minimal important difference (MID) for the OAB-q SF is 11 points. | Before treatment (baseline), 8 week (post-treatment) and 12 week (follow-up) |
| Urinary NGF/Cr level | Measured by human nerve growth factor (NGF) ELISA Kit. NGF/Cr: NGF normalized to urine creatinine (Cr) | Before treatment (baseline), 8 week (post-treatment) |
| Urinary BDNF/Cr level | Measured by human brain derived neurotrophic factor (BDNF) ELISA Kit. BDNF/Cr: BDNF normalized to urine creatinine (Cr) | Before treatment (baseline), 8 week (post-treatment) |
| Urinary MCP-1/Cr level | Measured by human monocyte chemoattractant protein-1 (MCP-1) ELISA Kit. MCP-1/Cr: MCP-1 normalized to urine creatinine (Cr) | Before treatment (baseline), 8 week (post-treatment) |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |