Benign Prostatic HyperplasiaEABPHNCT05585450
Effect of Electroacupuncture on Benign Prostatic Hyperplasia
A study testing Electroacupuncture in people with Benign Prostatic Hyperplasia, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
Trial summary
The study aims to assess the efficacy and safety of electroacupuncture among men with benign prostatic hyperplasia (BPH), compared with sham electroacupuncture. Read more about this study
- Who is it for?
- Ages 40 to 80 years, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Electroacupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 306 participants
- Where
- 1 siteChina
- Study dates
- 9 Mar 2023to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of BPH in accordance with the European Association of Urology (EAU) guideline;
- Male participants aged between 40 and 80 years;
- Lower urinary tract symptoms (LUTS) for at least three months;
- IPSS total score ≥8;
- Prostate volume ≥20 mL;
- Urinary peak flow rate (Qmax) ≤15 mL/s;
- Voluntary participation in the trial and signed written informed content.
Who cannot join
- Post-void residual urine volume (PVR) ≥150 mL;
- Acute urinary retention or catheterization for outflow obstruction within the 3 months (Except for post-surgical disposable catheterization);
- Prostate cancer or prostate-specific antigen (PSA) level ≥4.0 ng/mL;
- Neurogenic lower urinary tract dysfunction; prostatitis; uncontrolled symptomatic urinary tract infections; urethral strictures; bladder diverticula; bladder stones; bladder cancer; history of genitourinary system surgery (prostate, bladder, urethra, etc.);
- Previous acupuncture treatment for BPH in the preceding one month, or α-blockers, 5α-reductase inhibitor, muscarinic receptor antagonists, or any other specific medication usage in the previous two weeks unless a stable 5α-reductase inhibitor usage of over three months;
- Severe lung, heart, liver, kidney, metabolic, or mental illness, coagulation dysfunction, or with obvious cognitive dysfunction;
- Installed cardiac pacemaker, allergy to metal, severe fear of acupuncture or unbearable to the stimulation of EA.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100053
Zhishun Liu, +861088002331, zhishunjournal@163.com
About this study
Official title: Effect of Electroacupuncture on Lower Urinary Tract Symptoms of Benign Prostatic Hyperplasia: a Randomized Controlled Trial
The study aims to assess the efficacy and safety of electroacupuncture among men with benign prostatic hyperplasia (BPH), compared with sham electroacupuncture.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Electroacupuncture, Sham electroacupuncture
- Keywords
- acupuncture, randomized controlled trial, lower urinary tract symptoms
- Medical subject headings
- Prostatic Hyperplasia, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroacupunctureDevice
Also called EA
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.
Sham electroacupunctureDevice
Also called SA
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Electroacupuncture |
| 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. Receives: Device: Sham electroacupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: week 20
Secondary outcomes (14)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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?
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: weeks 8, 20, 32
The change from baseline in the volume of prostate
The prostate volume will be measured by transabdominal ultrasound.
Measured: 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.
Measured: 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.
Measured: 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".
Measured: weeks 8, 20, 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start9 Mar 2023
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 306 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Zhishun, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Zhishun Liu, Principal investigator, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05585450
- Sponsor's protocol ID
- 2022-203-KY
- Acronym
- EABPH
- Status last verified
- Jul 2024
- First submitted
- 13 Oct 2022
- Last updated
- 18 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 39032929
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Electroacupuncture on Lower Urinary Tract Symptoms of Benign Prostatic Hyperplasia: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05585450
- Acronym / sponsor ID
- EABPH / 2022-203-KY
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- acupuncture, randomized controlled trial, lower urinary tract symptoms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 306 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- 9 Mar 2023 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 18 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to assess the efficacy and safety of electroacupuncture among men with benign prostatic hyperplasia (BPH), compared with sham electroacupuncture.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electroacupuncture (EA) group | Experimental | Device: ElectroacupunctureParticipants 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 | Device: Sham electroacupunctureParticipants 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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of BPH in accordance with the European Association of Urology (EAU) guideline;
- Male participants aged between 40 and 80 years;
- Lower urinary tract symptoms (LUTS) for at least three months;
- IPSS total score ≥8;
- Prostate volume ≥20 mL;
Key exclusion criteria (7 listed)
- Post-void residual urine volume (PVR) ≥150 mL;
- Acute urinary retention or catheterization for outflow obstruction within the 3 months (Except for post-surgical disposable catheterization);
- Prostate cancer or prostate-specific antigen (PSA) level ≥4.0 ng/mL;
- Neurogenic lower urinary tract dysfunction; prostatitis; uncontrolled symptomatic urinary tract infections; urethral strictures; bladder diverticula; bladder stones; bladder cancer; history of genitourinary system surgery (prostate, bladder, urethra, etc.);
- Previous acupuncture treatment for BPH in the preceding one month, or α-blockers, 5α-reductase inhibitor, muscarinic receptor antagonists, or any other specific medication usage in the previous two weeks unless a stable 5α-reductase inhibitor usage of over three months;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElectroacupunctureAlso: EABL32 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. | Device | Electroacupuncture (EA) group |
| Sham electroacupunctureAlso: SAThe 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. | Device | Sham Electroacupuncture (SA) group |
Primary outcome
The proportion of participants with at least 30% reduction in the total score of International Prostate Symptom Score (IPSS) from baseline
Time frame: week 8
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.
The proportion of participants with at least 30% reduction in the total score of International Prostate Symptom Score (IPSS) from baseline
Time frame: week 20
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.
14 secondary outcomes
The change from baseline in the total score of IPSS
Time frame: weeks 4, 8, 12, 20, 32
The proportion of participants with at least 30% reduction in the total score of IPSS from baseline
Time frame: weeks 4, 12, 32
The proportion of participants with at least 50% reduction in the total score of IPSS from baseline
Time frame: weeks 4, 8, 12, 20, 32
The change from baseline in the voiding and storage subscale scores of IPSS
Time frame: weeks 4, 8, 12, 20, 32
The change from baseline in the number of nocturia
Time frame: weeks 4, 8, 12, 20, 32
The change from baseline in the quality of life (QOL) item of IPSS
Time frame: weeks 4, 8, 12, 20, 32
The change from baseline in the BPH Impact Index (BPH-II)
Time frame: weeks 4, 8, 12, 20, 32
The change from baseline in the International Index of Erectile Function 5 (IIEF-5)
Time frame: weeks 8, 20, 32
The change from baseline in the hours of undisturbed sleep (HUS)
Time frame: weeks 4, 8, 12, 20, 32
The change from baseline in the Hospital Anxiety and Depression Scale (HADS)
Time frame: weeks 8, 20, 32
The change from baseline in the volume of prostate
Time frame: week 8
The change from baseline in the post-void residual urine volume
Time frame: week 8
The change from baseline in the urinary peak and average flow rate
Time frame: week 8
The proportion of responders per the Patient Global Index of Improvement (PGI-I)
Time frame: weeks 8, 20, 32
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
- Derived from this study: PubMed 39032929Zhu 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhishun Liu principal investigator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroacupuncture in people with Benign Prostatic Hyperplasia, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhishun Liu (+861088002331, zhishunjournal@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of participants with at least 30% reduction in the total score of International Prostate Symptom Score (IPSS) from baseline (time frame: week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05585450, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2024.