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

Overview

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.

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. Parallel-group: Both groups are treated at the same time and followed for the same duration. Controlled: One group receives the standard treatment alone, while the other receives standard treatment plus the study medication. This allows researchers to see if the combination is truly better. Treatment Groups and Medications Group 1 (Control, about 68 participants): Takes one capsule (0.2 mg) of tamsulosin sustained-release orally once daily at bedtime for 8 weeks. This is the standard medication commonly prescribed after prostate surgery to help with urinary symptoms. The specific product is manufactured by Jiangsu Hengrui Medicine Co., Ltd. (National Drug Approval Number: H20000681). Group 2 (Experimental, about 68 participants): Takes the same dose of tamsulosin once daily at bedtime PLUS Lingze tablets (4 tablets, three times daily) for 8 weeks. Lingze tablets are manufactured by Zhejiang Conba Pharmaceutical Co., Ltd. (National Drug Approval Number: Z20110050). Each Lingze tablet contains herbal extracts including Rhizoma Alismatis, Poria, Radix Rehmanniae Preparata, Rhizoma Curculiginis, and Herba Epimedii. The combination aims to both relax the urinary tract (tamsulosin) and address underlying imbalances that traditional Chinese medicine associates with urinary problems (Lingze). All participants will receive standard postoperative care instructions, including guidance on diet, fluid intake, and activity levels. Participant Journey: What to Expect If you decide to participate, here is what will happen: Visit 0 (Baseline, Week 0): You will meet with the study doctor and nurse to review the study details and ask questions. If you agree to participate, you will sign the informed consent form. The team will collect basic information about you (age, medical history, how long you've had symptoms, other health conditions). You will complete several questionnaires that ask about your urinary symptoms, sleep quality, and anxiety levels (these take about 20-30 minutes total). You will undergo a non-invasive urine flow test where you urinate into a special device that measures how fast and how much you urinate. This helps measure bladder function. You will be randomly assigned to one of the two treatment groups and receive your first 4-week supply of medications with detailed instructions. The research team will explain how to take the medications, what side effects to watch for, and how to contact them with any concerns (a 24-hour hotline will be provided). Visit 1 (Week 4): You will return to the clinic with your medication bottles so the team can check how well you have been taking the medications (adherence check). You will complete the same questionnaires as at baseline to track any changes in your symptoms, sleep, and quality of life. You will report any side effects or problems you have experienced. The doctor will answer your questions and provide health education about managing urinary symptoms. You will receive your second 4-week supply of medications. Visit 2 (Final Visit, Week 8): You will return to the clinic for your final assessment. You will repeat all the questionnaires and the urine flow test. You will return all medication bottles for a final adherence check. The team will review your overall experience, any side effects, and your symptom improvement. You will receive advice on continuing your treatment plan with your regular doctor after the study ends. Throughout the 8-week period, you are encouraged to contact the study team at any time if you have questions, concerns about side effects, or any health issues. The team will also contact you by phone, text message, or email between visits as needed to check on your progress. How We Will Measure Success: Outcome Measures The study will evaluate several key areas: Urinary Symptom Severity (IPSS): The International Prostate Symptom Score is a 7-question survey that asks how often you experience symptoms like incomplete emptying, frequent urination, weak stream, and nighttime urination. Each question is scored from 0 (not at all) to 5 (almost always), for a total score of 0-35. Lower scores mean fewer symptoms. This is the most common tool used worldwide to assess prostate-related urinary problems. Quality of Life Impact (QOL): A single question asks: "If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?" You rate your answer from 0 (delighted) to 6 (terrible). This helps us understand how much your symptoms truly bother you. Nighttime Urination (Nocturia): Specifically, we will count how many times you wake up each night to urinate. The IPSS questionnaire includes this as one item, but we will also track it separately as a primary focus of this study. Sleep Quality (PSQI): The Pittsburgh Sleep Quality Index asks 19 questions about your sleep over the past month, covering 7 areas: sleep quality, how long it takes you to fall asleep, total sleep time, sleep efficiency (time in bed vs. time asleep), sleep disturbances (like waking up at night), use of sleep medications, and daytime sleepiness. Each area is scored 0-3, for a total score of 0-21. A lower score means better sleep quality. This is a well-validated tool used internationally. Bladder Function (Urodynamic Parameters): We will perform simple, non-invasive tests: Maximum Urine Flow Rate (Qmax): Measures the fastest speed of your urine stream (in milliliters per second). A higher number means better flow. Average Urine Flow Rate (Qave): Measures the average speed throughout your urination. Residual Urine Volume (RUV): Uses ultrasound to measure how much urine remains in your bladder after you urinate. Less residual urine means your bladder is emptying more completely. Anxiety Level (HAMA): The Hamilton Anxiety Rating Scale includes 14 items about anxiety symptoms (like tension, fear, insomnia, muscle aches). Each item is rated from 0 (not present) to 4 (severe). The total score helps us understand if urinary and sleep problems are affecting your emotional health. Safety and Side Effects: At every contact, we will ask about any health problems, symptoms, or concerns you have experienced. We will record details about any adverse events: what happened, when it started, how severe it was, how long it lasted, what was done about it, and what the outcome was. Common potential side effects from these medications include dizziness (especially when standing up), headache, nasal congestion, fatigue, nausea, or stomach discomfort. Most side effects are mild and temporary. Sample Size and Statistics We calculated that we need 136 participants (68 in each group) to have enough statistical power to detect a meaningful difference between the two treatments. This calculation assumes that the combination therapy will reduce nighttime urination by at least 1 fewer episode per night compared to tamsulosin alone, with a 90% chance of detecting this difference if it truly exists. We added extra participants to account for an estimated 20% who might drop out or be lost to follow-up. Data will be analyzed using SPSS 20.0 software. For continuous measures (like scores and urine flow rates), we will compare the average changes between groups using t-tests. For categorical data (like percentages of people with side effects), we will use chi-square tests. A p-value less than 0.05 will be considered statistically significant, meaning the difference is unlikely to be due to chance. Quality Control and Data Integrity To ensure reliable results, we will: Verify that all participants meet strict inclusion and exclusion criteria before enrollment. Use a random number table generated by computer to assign participants to groups, preventing any bias. Check medication adherence at each visit by counting remaining pills and asking participants about missed doses. Monitor for adverse events continuously and have a physician available 24/7 for urgent concerns. Keep the data analysts "blinded" to which participant is in which group until the final analysis is complete, to prevent unconscious bias in interpreting results. Use standardized, validated questionnaires and measurement techniques at all time points. Privacy and Confidentiality All information collected about you will be kept strictly confidential. Your data will be assigned a unique study ID number, and your name and other direct identifiers will be stored separately in a password-protected database accessible only to essential study staff. Any information published or presented will not identify you personally. All data collection, storage, and analysis comply with hospital policies and national regulations protecting research participants. Participation Rights Your participation is completely voluntary. You have the right to: Ask questions about the study at any time Refuse to participate without any penalty or loss of medical care Withdraw from the study at any time for any reason Receive a copy of your signed consent form Be informed of any new information that might affect your willingness to continue Contact Information For questions about the study, your rights as a participant, or to report problems, you can contact: Principal Investigator: Dr. Guangyi Huang 24-Hour Study Hotline: \[To be provided at enrollment\] Institutional Review Board: \[Hospital Ethics Committee contact information will be provided\] Results Sharing After the study is completed, we plan to publish the findings in a medical journal and present them at scientific conferences. A summary of results will be made available to all participants who request it.