N/A
N=440
Acupuncture for Chronic Prostatitis/Chronic Pelvic Pain Syndrome
Chronic Prostatitis With Chronic Pelvic Pain Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT03213938 ↗Enrolled (actual)
440
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcome: Primary: Proportion of Responders at the End of 8-week — 60.6; 36.8 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Acupuncture (Device); Sham acupuncture (Device)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Responders at the End of 8-week |
60.6; 36.8 | — |
| PRIMARY Proportion of Responders at the End of 32-week |
61.5; 38.3 | — |
| SECONDARY Proportion of Responders at Other Time Points |
9.1; 8.3; 15.2; 13.9; 27.2; 19.8 | — |
| SECONDARY the Change From Baseline in NIH-CPSI Total Score |
-1.9; -1.3; -2.9; -2.4; -3.9; -3.0 | — |
| SECONDARY the Change From Baseline in NIH-CPSI Subscales |
-0.6; -0.5; -0.8; -0.8; -1.1; -0.8 | — |
| SECONDARY the Change From Baseline in the International Prostate Symptom Score (IPSS) |
-2.7; -1.7; -4.4; -2.7; -4.7; -3.0 | — |
| SECONDARY the Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) |
-1.9; -0.8; -2.4; -0.6; -2.8; -0.5 | — |
| SECONDARY the Change From Baseline in the International Index of Erectile Function 5 (IIEF-5) |
0.8; 0.3; 0.7; 0.2; 1.0; 0.4 | — |
| SECONDARY the Change From Baseline in the European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Questionnaire |
0.06; 0.03; 0.06; 0.03; 0.06; 0.03 | — |
| SECONDARY the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA) |
15.9; 7.5; 24.0; 14.6; 46.6; 50.7 | — |
| SECONDARY the Change for Peak and Average Urinary Flow Rate From Baseline |
0.6; 0.7; 0.5; -0.6; 0.6; 0.4 | — |
Summary
Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) refers to the presence of bothersome pelvic pain symptoms without an identifiable cause. Common symptoms of CP/CPPS include discomfort in the perineum, suprapubic region, and lower urinary tract symptoms. It affects men of all ages without apparent racial predisposition, among which, 36-50 years old are the most commonly influenced. Yet, few effective therapies are available for treating CP/CPPS.
Acupuncture may be an effective treatment option for CP/CPPS. However, effects of acupuncture on CP/CPPS remain uncertain because of the small sample sizes or other methodological limitations.
The objective of this multi-centre, randomized, sham acupuncture-controlled trial is to assess the effectiveness of acupuncture for relieving symptoms of CP/CPPS. The results will provide a robust conclusion with a high level of evidence.
Eligibility Criteria
Inclusion Criteria
- 1.History of pain perceived in the prostate region and absence of other lower urinary tract pathology for a minimum of three of the past 6 months. In addition, any associated lower urinary tract symptoms, sexual function, and psychological factors should be addressed. Physical examinations, urinary analyses, and urine cultures will be performed for all subjects;
- 2. Age 18 to 50 years.
- 3. NIH Chronic Prostatitis Symptom Index (NIH- CPSI) total score ≥ 15.
Exclusion Criteria
- 1. Prostate, bladder, or urethral cancer, seizure disorder in any medical history.
- 2. Inflammatory bowel disease, active urethral stricture, neurologic disease or disorder affecting the bladder, liver disease, neurologic impairment or psychiatric disorder preventing understanding of consent and self-report scale.
- 3. Urinary tract infection with a urine culture value of more than 100,000 CFU/mL, clinical evidence of urethritis, including urethral discharge or positive culture, diagnostic of sexually transmitted diseases (including gonorrhoea, chlamydia, mycoplasma or trichomonas, but not including HIV/AIDS), symptoms of acute or chronic epididymitis).
- 4. Residual urine volume≥100ML.
- 5. Qmax≤15ML/S.
- 6. Prior 4 weeks used androgen hormone inhibitors (finasteride), alpha-blockers (terazosin HCI, doxazosin mesylate, tamsulosin hydrochloride), antibiotics (ciprofloxacin hydrochloride), or any other prostatitis-specific medication (including herb and Chinese medicine).
Data sourced from ClinicalTrials.gov (NCT03213938). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.