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 study aims to assess the efficacy and safety of electroacupuncture among men with benign prostatic hyperplasia (BPH), compared with sham electroacupuncture.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electroacupuncture (EA) group | Experimental | Participants in the EA group will receive treatment at bilateral Bladder Meridian (BL) 32 [Ciliao], BL33 [Zhongliao], BL35 [Huiyang], and Spleen Meridian (SP) 6 [Sanyinjiao]. BL32, in the second posterior sacral foramen; BL33, in the third posterior sacral foramen; BL35, 0.5 cun (≈10mm) lateral to the extremity of the coccyx; SP6, posterior to the medial border of the tibia, 3 cun (≈60mm) superior to the prominence of the medial malleolus. The treatment will last 30 minutes for each session, 3 sessions per week (ideally every other day) for a succession of 8 weeks. |
|
| Sham Electroacupuncture (SA) group | Sham Comparator | Participants in the SA group will receive treatment at bilateral sham BL32, BL33, BL35, and SP6. Sham BL32, in the area of 2 cun (≈40mm) horizontally outside BL32; Sham BL33, in the area of 2 cun (≈40mm) horizontally outside BL33; Sham BL35, 2 cun (≈40mm) horizontally outside BL35; Sham SP6, in the middle of SP6 and tendons. The treatment will last 30 minutes for each session, 3 sessions per week (ideally every other day) for a succession of 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electroacupuncture | Device | BL32 and BL33 will be inserted by needles of 0.30×75mm size at an angle of 45°, inward and downward, to the depth of 60-70mm. BL35 will be inserted by needles of 0.30×75mm size, slightly outward and upward, to the depth of 60-70mm. SP6 will be inserted by needles of 0.30×40mm to the depth of 25-30mm. The needles will be lifted, thrust, and twisted evenly three times after insertion to induce the sensation of deqi. The electronic acupuncture apparatus (Yingdi KWD 808I electro pulse acupuncture therapeutic apparatus, Changzhou Yingdi Electronic Medical Device Co., Ltd) will be connected to the four pairs of needles transversally, with a continuous wave of 5 Hertz (Hz) and an electric current of 2-6.5 milliampere (mA) for BL32, BL33 and BL35, and 0.5 mA-2mA for SP6. |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of participants with at least 30% reduction in the total score of International Prostate Symptom Score (IPSS) from baseline | The IPSS is a valid, reliable, and sensitive measure tool frequently used to evaluate the severity of lower urinary tract symptoms, including incomplete bladder emptying, frequency of urination, intermittency, urgency, weak urine stream, straining, and nocturia. The score of IPSS ranges from 0 to 35, with scores of 0 to 7 indicating mild symptoms; 8 to 19 indicating moderate symptoms; and 20 to 35 indicating severe symptoms. | week 8 |
| The proportion of participants with at least 30% reduction in the total score of International Prostate Symptom Score (IPSS) from baseline | The IPSS is a valid, reliable, and sensitive measure tool frequently used to evaluate the severity of lower urinary tract symptoms, including incomplete bladder emptying, frequency of urination, intermittency, urgency, weak urine stream, straining, and nocturia. The score of IPSS ranges from 0 to 35, with scores of 0 to 7 indicating mild symptoms; 8 to 19 indicating moderate symptoms; and 20 to 35 indicating severe symptoms. | week 20 |
| Measure | Description | Time Frame |
|---|---|---|
| The change from baseline in the total score of IPSS | The IPSS is a valid, reliable, and sensitive measure tool frequently used to evaluate the severity of lower urinary tract symptoms, including incomplete bladder emptying, frequency of urination, intermittency, urgency, weak urine stream, straining, and nocturia. The score of IPSS ranges from 0 to 35, with scores of 0 to 7 indicating mild symptoms; 8 to 19 indicating moderate symptoms; and 20 to 35 indicating severe symptoms. |
| Measure | Description | Time Frame |
|---|---|---|
| Expectance assessment | Participants will be asked: How do you expect your lower urinary tract symptoms (LUTS) will be in two months? | Baseline assessment (week 0) |
| Assessment of belief in acupuncture | Participants will be asked the question: Do you think your BPH may be helped by acupuncture? Time Frame: Baseline assessment (week 0) and week 8 Participants will be asked the question: Do you think your BPH may be helped by electroacupuncture? |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhishun Liu | Contact | +861088002331 | zhishunjournal@163.com | |
| Lili Zhu | Contact | +8618851182160 | julius.zhu@foxmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhishun Liu | Guang'anmen Hospital of China Academy of Chinese Medical Sciences | 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 |
|---|---|---|---|
| 39032929 | Derived | Zhu L, Yan Y, Yu J, Liu Y, Sun Y, Chen Y, Fang J, Liu Z. Electroacupuncture for lower urinary tract symptoms in men with benign prostatic hyperplasia: study protocol for a randomised controlled trial. BMJ Open. 2024 Jul 20;14(7):e080743. doi: 10.1136/bmjopen-2023-080743. |
Not provided
Not provided
Deidentified participant data and data dictionary will be available with the publication until six months after publication.
A formal request should be sent to zhishunjournal@163.com with a methodologically sound proposal.
Researchers whose proposal has been approved will sign a data access agreement.
The data will be available with the publication until six months after publication.
A formal request should be sent to zhishunjournal@163.com with a methodologically sound proposal. Researchers whose proposal has been approved.
Researchers whose proposal has been approved will sign a data access agreement.
Not provided
Not provided
| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| D059411 | Lower Urinary Tract Symptoms |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015671 | Electroacupuncture |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D015670 | Acupuncture Therapy |
| D000529 | Complementary Therapies |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Sham electroacupuncture | Device | The four pairs of acupoints will be inserted by needles of 0.30×25mm or 0.30×40mm size to a depth of 2-3mm till the needles can stand still. No manipulations will be conducted, and the sensation of deqi will not be induced. The electronic acupuncture apparatus (Yingdi KWD 808I electro pulse acupuncture therapeutic apparatus, Changzhou Yingdi Electronic Medical Device Co., Ltd) will be connected to the four pairs of needles transversally, with a continuous wave of 5 Hz and a minimal electric current (ideally at a degree which participant can just percept). In about 30 seconds, the electric current will be turned down, leaving the indicator light and ticking sound on. |
|
|
| weeks 4, 8, 12, 20, 32 |
| The proportion of participants with at least 30% reduction in the total score of IPSS from baseline | The IPSS is a valid, reliable, and sensitive measure tool frequently used to evaluate the severity of lower urinary tract symptoms, including incomplete bladder emptying, frequency of urination, intermittency, urgency, weak urine stream, straining, and nocturia. The score of IPSS ranges from 0 to 35, with scores of 0 to 7 indicating mild symptoms; 8 to 19 indicating moderate symptoms; and 20 to 35 indicating severe symptoms. | weeks 4, 12, 32 |
| The proportion of participants with at least 50% reduction in the total score of IPSS from baseline | The IPSS is a valid, reliable, and sensitive measure tool frequently used to evaluate the severity of lower urinary tract symptoms, including incomplete bladder emptying, frequency of urination, intermittency, urgency, weak urine stream, straining, and nocturia. The score of IPSS ranges from 0 to 35, with scores of 0 to 7 indicating mild symptoms; 8 to 19 indicating moderate symptoms; and 20 to 35 indicating severe symptoms. | weeks 4, 8, 12, 20, 32 |
| The change from baseline in the voiding and storage subscale scores of IPSS | The IPSS is a valid, reliable, and sensitive measure tool frequently used to evaluate the severity of lower urinary tract symptoms, including incomplete bladder emptying, frequency of urination, intermittency, urgency, weak urine stream, straining, and nocturia. The score of IPSS ranges from 0 to 35, with scores of 0 to 7 indicating mild symptoms; 8 to 19 indicating moderate symptoms; and 20 to 35 indicating severe symptoms. | weeks 4, 8, 12, 20, 32 |
| The change from baseline in the number of nocturia | Participants will be asked: During the last month, how many times did you most typically get up to urinate from the time you went to bed at night until the time you got up in the morning? | weeks 4, 8, 12, 20, 32 |
| The change from baseline in the quality of life (QOL) item of IPSS | Participants will be asked the question: If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that? The response categorized into 7 degrees scoring 0 to 6, respectively: 0 (delighted), 1 (pleased), 2 (mostly satisfied), 3 (mixed about equally satisfied and dissatisfied), 5 (mostly dissatisfied), 5 (unhappy), and 6 (terrible). | weeks 4, 8, 12, 20, 32 |
| The change from baseline in the BPH Impact Index (BPH-II) | The BPH-II measures the interference of LUTS in patients' mental health and activity. The total score of BPH-II ranges from 0 to 13, with higher scores indicating poorer quality of life. | weeks 4, 8, 12, 20, 32 |
| The change from baseline in the International Index of Erectile Function 5 (IIEF-5) | The IIEF-5 is a valid and reliable instrument for detecting treatment effects in patients with erection dysfunction, ranging from 1 to 25, with lower scores indicating more severe dysfunction. | weeks 8, 20, 32 |
| The change from baseline in the hours of undisturbed sleep (HUS) | HUS is defined as the duration from falling asleep till awake in the morning, or till the first nocturia if any. | weeks 4, 8, 12, 20, 32 |
| The change from baseline in the Hospital Anxiety and Depression Scale (HADS) | The HADS score ranges from 0 to 42, with higher scores indicating greater anxiety and depression. | weeks 8, 20, 32 |
| The change from baseline in the volume of prostate | The prostate volume will be measured by transabdominal ultrasound. | week 8 |
| The change from baseline in the post-void residual urine volume | The post-void residual urine volume will be measured by transabdominal ultrasound. | week 8 |
| The change from baseline in the urinary peak and average flow rate | The urinary peak and average flow rate will be measured by uroflowmetry. | week 8 |
| The proportion of responders per the Patient Global Index of Improvement (PGI-I) | The PGI-I evaluates the overall treatment effect perceived by patients themselves. The change can be rated in 7 levels, including "very much better", "much better", "a little better", "no change", "a little worse", "much worse" or "very much worse". | weeks 8, 20, 32 |
| Baseline assessment (week 0) and week 8 |
| Blinding assessment | Participants will be asked the question: Do you think you have received traditional electroacupuncture in the past 8 weeks? | Within 5 minutes after either treatment at week 8 |
| Safety assessment | Adverse events and severe adverse events will be recorded in the case report form, whether related to interventions or not. | Throughout the trial |
| Adherence assessment | Adherence will be assessed via counting treatment sessions. Those who complete over 80% treatment sessions will be defined as of good adherence. | weeks 1-8 |
| D052801 |
| Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004599 |
| Electric Stimulation Therapy |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D004561 | Transcutaneous Electric Nerve Stimulation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
| D000758 | Anesthesia |