Evidence map›Paper›PMID 31555554›Full record

ArticleTranslational andrology and urology2019

Efficacy and safety of novel low-intensity pulsed ultrasound (LIPUS) in treating mild to moderate erectile dysfunction: a multicenter, randomized, double-blind, sham-controlled clinical study.

Wanshou Cui, Huixi Li, Ruili Guan, Meng Li, Bicheng Yang, Zhanwei Xu, Maofan Lin, Long Tian, Xiaodong Zhang, Bao Li and 8 more

Abstract read
In one paragraph

Article in Translational andrology and urology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

26 citing papers in PubMed.

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  12. Age-related testosterone decline: mechanisms and intervention strategies.Reproductive biology and endocrinology : RB&E · 2024
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors.

Wanshou CuiAndrology Center, Peking University First Hospital, Beijing 100034, China.
Huixi LiAndrology Center, Peking University First Hospital, Beijing 100034, China.
Ruili GuanAndrology Center, Peking University First Hospital, Beijing 100034, China.
Meng LiAndrology Center, Peking University First Hospital, Beijing 100034, China.
Bicheng YangAndrology Center, Peking University First Hospital, Beijing 100034, China.
Zhanwei XuWanbeili Medical instrument Co., Ltd., Beijing 102200, China.
Maofan LinWanbeili Medical instrument Co., Ltd., Beijing 102200, China.
Long TianDepartment of Urology, Beijing Chaoyang Hospital, Beijing 100020, China.
Xiaodong ZhangDepartment of Urology, Beijing Chaoyang Hospital, Beijing 100020, China.
Bao LiDepartment of Urology, Affiliated Hospital of Weifang Medical University, Weifang 261031, China.
Weiguang LiuDepartment of Urology, Affiliated Hospital of Weifang Medical University, Weifang 261031, China.
Zhilong DongDepartment of Urology, Lanzhou University Second Hospital, Lanzhou 730030, China.
Zhiping WangDepartment of Urology, Lanzhou University Second Hospital, Lanzhou 730030, China.
Tao ZhengDepartment of Urology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, China.
Weixing ZhangDepartment of Urology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, China.
Guiting LinKnuppe Molecular Urology Laboratory, Department of Urology, School of Medicine, University of California, San Francisco, CA, USA.
Yinglu GuoAndrology Center, Peking University First Hospital, Beijing 100034, China.
Zhongcheng XinAndrology Center, Peking University First Hospital, Beijing 100034, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn our previous study, a novel low-intensity pulsed ultrasound (LIPUS) therapeutic device has been shown to improve erectile function non-invasively in a diabetic-induced erectile dysfunction (ED) animal model.

methodsIn order to investigate the efficacy and safety of LIPUS in the clinical treatment of patients with ED, a multicenter, randomized, double-blind, sham-treated, controlled clinical study was conducted at five medical centers, and 120 patients with mild to moderate ED were enrolled in the study. Patients were randomized into a sham-treated control group (40 patients) or a LIPUS-treated group (80 patients). LIPUS or sham treatment was applied to both sides of the penis shaft and crus for 5 min in each area, twice a week for four weeks. Assessment of efficacy and safety were evaluated using IIEF-5, Sexual Encounter Profile (SEP)-questionnaires 2/3, Global Assessment Question (GAQ), Erectile Hardness Score (EHS), Erection Quality Scale (EQS) score, and pain assessment [Visual Analogue Scale/Score (VAS)].

resultsTen patients in LIPUS treatment group and 6 patients in sham treatment control group were excluded and the dropout rate is 13.33%. Response to treatment was identified as IIEF-5 score increased more than 2/3/4 points of post-treatment (12W) compared to pre-treatment (0W). The response rate in treatment group was 54/80 (67.50%), which was significantly higher than control group 8/40 (20.00%) at 12 weeks (FAS analysis). The percentage of patients with positive answers to SEP-3 (successful vaginal intercourse) were 58.97%, 64.1%, and 73.08% 4, 8, and 12 weeks after treatment which were significantly higher than 28.95%, 31.58%, and 28.95% respectively in control group (FAS, P<0.05). The positive responsive rates for GAQ in treatment group were about 2 to 3 times of that in control group (P<0.05). No treatment-related adverse events (AEs) were found, including local petechia or ecchymosis and hematuria.

conclusionsCurrent study indicates that LIPUS can safely and effectively treat patients with mild to moderate ED without significant AEs, which is related to the mechanical force of LIPUS and can restore the pathological changes of the corpus cavernosum. LIPUS is a promising alternative treatment for ED treatment in the near future, while further research is remanded.

Indexed as

erectile dysfunction (ED)IIEF-5 scoreLow-intensity pulsed ultrasound (LIPUS)pain assessmenttreatment

Identifiers

PMID31555554
PMCPMC6732092

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.