A Clinical Observation Study of a Chinese Patent Medicine Combined With Tamsulosin in Improving Sleep and Nocturia Symptoms After Enucleation of the Prostate
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 136
研究概览
简要总结
This study will test whether a traditional Chinese medicine called Lingze tablets, when added to the standard drug tamsulosin, can better improve sleep and nighttime urination problems in men after prostate surgery.
Who can participate? Men aged 50 years or older who have had transurethral holmium laser enucleation of the prostate (a minimally invasive surgery for enlarged prostate) and continue to have bothersome nighttime urination (at least 2 times per night) and other urinary symptoms may be eligible.
Who cannot participate? Men who cannot tolerate the study medications, have severe cancer, serious organ failure, or have conditions that prevent them from understanding or following the study requirements.
What will participants do?
About 136 participants will be randomly assigned (by chance, like a coin flip) to one of two groups:
Group 1: Take tamsulosin sustained-release capsule once daily for 8 weeks Group 2: Take tamsulosin sustained-release capsule once daily PLUS Lingze tablets (4 tablets, three times daily) for 8 weeks Participants will visit the hospital clinic at the start of the study, at 4 weeks, and at 8 weeks for assessments.
What will be measured?
Researchers will measure:
How many times you wake up at night to urinate Overall sleep quality using standard questionnaires Prostate symptom scores and quality of life Urine flow tests (non-invasive) Anxiety levels Any side effects or adverse events from the medications Why is this study important? Many men continue to have nighttime urination and poor sleep even after prostate surgery, which can greatly reduce quality of life. This study will help determine if combining Lingze tablets with standard treatment provides better relief than standard treatment alone.
Risks and Benefits:
Potential benefits: Improved sleep, fewer nighttime bathroom trips, better urinary symptoms, and enhanced quality of life.
Potential risks: Possible side effects include dizziness, headache, nausea, or stomach upset from the medications. All participants will be closely monitored for any problems and can contact the study team 24/7 with concerns.
Privacy:
All personal and medical information will be kept confidential and used only for research purposes in accordance with hospital and national regulations.
详细描述
This study is designed to test whether adding a traditional Chinese medicine called Lingze tablets to the standard treatment (tamsulosin) can better relieve nighttime urination and sleep problems in men who have recently undergone a minimally invasive prostate surgery.
Why This Study Is Needed Many men develop an enlarged prostate (benign prostatic hyperplasia, or BPH) as they age, which can cause bothersome urinary symptoms. The standard surgical treatment is transurethral holmium laser enucleation of the prostate, a procedure that removes part of the prostate to improve urine flow. While this surgery is effective, up to half of men continue to experience significant urinary symptoms afterward, particularly needing to wake up frequently at night to urinate (nocturia). Poor sleep due to nocturia leads to daytime fatigue, reduced quality of life, and emotional distress. Current medications like tamsulosin (which relaxes the bladder and prostate muscles) help some men but don't fully resolve symptoms for everyone. Lingze tablets are a Chinese patent medicine made from herbal ingredients that, according to traditional Chinese medicine theory, work by strengthening kidney function and clearing dampness and heat from the body. Previous small studies suggest Lingze tablets may help with urinary symptoms, but this has not been tested in men after prostate surgery or combined with standard treatment.
Study Design
This is a randomized, parallel-group, controlled clinical trial meaning:
Randomized: Participants are assigned by chance (like flipping a coin) to one of two treatment groups. This helps ensure the groups are similar and the results are fair.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
This is a single-blind study. Due to the different dosing regimens between the two groups (tamsulosin once daily vs. tamsulosin once daily plus Lingze tablets three times daily), it is not possible to blind participants or care providers. However, the outcomes assessors responsible for collecting questionnaire data (IPSS, PSQI, HAMA) and urodynamic measurements will be blinded to group allocation. Additionally, the statistician/data analyst will remain blinded to treatment assignments during data processing and analysis to minimize bias.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients aged 50 years or older
- •History of transurethral holmium laser enucleation of the prostate (HoLEP)
- •Nocturia frequency ≥2 times per night
- •Documented bladder outlet obstruction
- •Presence of postoperative urinary incontinence and urgency symptoms
- •Ability to understand study procedures and provide written informed consent
- •Willingness to complete all scheduled follow-up visits and assessments
排除标准
- •Known hypersensitivity or intolerance to tamsulosin hydrochloride, Lingze tablets, or any component of these medications
- •Active malignancy or severe cancer requiring treatment
- •Cognitive impairment, psychiatric disorder, or language barrier that prevents understanding of study requirements or completion of questionnaires
- •Severe multi-organ failure or dysfunction that would interfere with study participation
- •Previous enrollment in conflicting clinical trials within the past 30 days
- •Inability to comply with the medication regimen or study protocol