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

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.

• Change in Sleep Quality from Baseline to Week 8 [Срок оценки: Baseline (Week 0) to Week 8]