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.
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
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
Parallel
Tamsulosin Hydrochloride Sustained-Release Capsules
DrugTamsulosin is an alpha-1 adrenergic receptor antagonist used as standard therapy to relieve lower urinary tract symptoms by relaxing the smooth muscle of the bladder neck and prostate. This study uses 0.2 mg sustained-release capsules administered orally once daily at bedtime for 8 weeks. The medication (National Drug Approval Number: H20000681) is manufactured by Jiangsu Hengrui Medicine Co., Ltd. It is administered to participants in both the control arm (monotherapy) and the experimental arm (combination therapy).
Lingze Tablets
DrugLingze tablets are a traditional Chinese patent medicine composed of herbal extracts including Rhizoma Alismatis, Poria, Radix Rehmanniae Preparata, Rhizoma Curculiginis, and Herba Epimedii. According to traditional Chinese medicine theory, it tonifies kidney qi, clears dampness and heat, and promotes blood circulation to alleviate urinary symptoms. In this study, it is administered orally at 4 tablets three times daily for 8 weeks, in combination with tamsulosin, to participants in the experimental arm only. The product (National Drug Approval Number: Z20110050) is manufactured by Zhejiang Conba Pharmaceutical Co., Ltd.
Change in Nocturia Frequency from Baseline to Week 8
The co-primary outcomes are: (1) Change in nocturia frequency, measured by Question 7 of the International Prostate Symptom Score (IPSS) which asks "Over the past 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?" (score range 0-5).
Change in Sleep Quality from Baseline to Week 8
Change in sleep quality, measured by the Pittsburgh Sleep Quality Index (PSQI) total score (range 0-21, higher scores indicate worse sleep quality)
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