Study of Lingze Tablets Plus Tamsulosin to Improve Sleep and Nighttime Urination in Men After Prostate Surgery

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.

A Clinical Observation Study of a Chinese Patent Medicine Combined With Tamsulosin in Improving Sleep and Nocturia Symptoms After Enucleation of the Prostate