Actively Recruiting
A Clinical Observation Study of a Chinese Patent Medicine Combined With Tamsulosin in Improving Sleep and Nocturia Symptoms After Enucleation of the Prostate
Led by The Fourth Affiliated Hospital of Zhejiang University School of Medicine · Updated on 2026-01-22
136
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate whether adding a traditional Chinese medicine called Lingze tablets to the standard drug tamsulosin can better improve sleep quality and reduce nighttime urination problems in men who have undergone transurethral holmium laser enucleation of the prostate, a minimally invasive surgery for enlarged prostate. Many men continue to experience bothersome urinary symptoms and poor sleep after surgery, which can significantly affect their quality of life. This trial compares standard treatment to a combination approach to see if the addition of Lingze tablets offers added benefits. Participants will be randomly assigned to one of two groups. One group will take tamsulosin sustained-release capsules (0.2 mg) orally once daily at bedtime for 8 weeks. The other group will take the same tamsulosin dose plus Lingze tablets (4 tablets, three times daily) for 8 weeks. Lingze tablets are herbal-based and thought to support kidney function and clear bodily dampness and heat according to traditional Chinese medicine. Both groups will receive standard postoperative care guidance on diet, fluid intake, and activity. During the study, participants will visit the clinic at the start, 4 weeks, and 8 weeks for assessments. They will complete questionnaires on urinary symptoms, sleep quality, anxiety, and quality of life. Non-invasive urine flow tests and bladder ultrasounds will measure urinary function. Medication adherence and any side effects will be monitored. The primary outcome is the change in nighttime urination frequency over 8 weeks, with secondary outcomes including sleep quality and symptom severity. Safety and privacy are carefully maintained throughout the study.
CONDITIONS
Brief Title
A Clinical Observation Study of a Chinese Patent Medicine Combined With Tamsulosin in Improving Sleep and Nocturia Symptoms After Enucleation of the Prostate
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male patients aged 50 years or older
- History of transurethral holmium laser enucleation of the prostate (HoLEP)
- Nocturia frequency at least 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment before enrollment
Duration - 8 weeks
Participants take either tamsulosin alone or tamsulosin combined with Lingze tablets for 8 weeks following prostate surgery to improve urinary symptoms and sleep quality.
3 in-person visits: baseline (Week 0), Week 4, and Week 8 final visit
Duration - 8 weeks concurrent with treatment
Participants are monitored through phone, text, or email contacts as needed for side effects, medication adherence, and symptom progress during the 8-week treatment period.
Ongoing remote contacts between in-person visits
Trial Site Locations
Total: 1 location
1
The Fourth Affiliated Hospital of School of Medicine, and International School of Medicine, International Institutes of Medicine，Zhejiang University
Yiwu, Zhejiang, China, 322000
Actively Recruiting
Research Team
G
Guangyi Huang, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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