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

NCT07357324 | Recruiting Phase 4 DMC

• 1 other identifier: KY-2025-144
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Benign Prostatic Hyperplasia; Nocturia Associated With Nocturnal Polyuria

Keywords

Benign Prostatic Hyperplasia; Transurethral Holmium Laser Enucleation of Prostate; Tamsulosin; Lingze Tablets

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline (Week 0) to Week 8

Secondary Outcomes (1)

• Change in Sleep Quality from Baseline to Week 8

  Baseline (Week 0) to Week 8

Study Arms (2)

Tamsulosin Monotherapy Group

ACTIVE COMPARATOR

Participants in this arm will receive tamsulosin hydrochloride sustained-release capsules (0.2 mg) orally once daily at bedtime for 8 weeks. This represents the standard postoperative pharmacological treatment following transurethral holmium laser enucleation of the prostate. The medication (National Drug Approval Number: H20000681) is manufactured by Jiangsu Hengrui Medicine Co., Ltd. Participants will be instructed to take the capsule with water and avoid crushing or chewing it. Regular monitoring for adverse events, medication adherence, and urinary/sleep symptom progression will be conducted at baseline, Week 4, and Week 8 visits.

Drug: Tamsulosin Hydrochloride Sustained-Release Capsules

Lingze Tablets Combined with Tamsulosin Group

EXPERIMENTAL

Participants in this arm will receive combination therapy consisting of Lingze tablets plus tamsulosin hydrochloride sustained-release capsules for 8 weeks. Lingze tablets (National Drug Approval Number: Z20110050), manufactured by Zhejiang Conba Pharmaceutical Co., Ltd., will be administered orally at a dose of 4 tablets three times daily. Tamsulosin hydrochloride sustained-release capsules (0.2 mg) will be administered orally once daily at bedtime. This experimental intervention aims to evaluate whether the addition of Lingze tablets, a traditional Chinese patent medicine with kidney-tonifying and dampness-clearing properties, to standard tamsulosin therapy provides superior improvement in postoperative nocturia and sleep quality compared to tamsulosin monotherapy. Participants will be monitored for medication adherence, adverse events, and clinical outcomes at baseline, Week 4, and Week 8 visits.

Drug: Tamsulosin Hydrochloride Sustained-Release Capsules; Drug: Lingze Tablets

Interventions

Tamsulosin Hydrochloride Sustained-Release Capsules DRUG

Tamsulosin 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).

Also known as: Tamsulosin, α1-adrenergic receptor antagonist

Lingze Tablets Combined with Tamsulosin Group; Tamsulosin Monotherapy Group

Lingze Tablets DRUG

Lingze 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.

Lingze Tablets Combined with Tamsulosin Group

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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 may not qualify if:

• 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

Sponsors & Collaborators

• The Fourth Affiliated Hospital of Zhejiang University School of Medicine: lead

Study Sites (1)

The Fourth Affiliated Hospital of School of Medicine, and International School of Medicine, International Institutes of Medicine，Zhejiang University

Yiwu, Zhejiang, 322000, China

RECRUITING

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Tamsulosin

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Central Study Contacts

Guangyi Huang, MD

CONTACT

15958911425; patri7k@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This is a single-blind study. Due to the different dosing regimens between the two groups (tamsulosin once daily vs. tamsulosin once daily plus Lingze tablets three times daily), it is not possible to blind participants or care providers. However, the outcomes assessors responsible for collecting questionnaire data (IPSS, PSQI, HAMA) and urodynamic measurements will be blinded to group allocation. Additionally, the statistician/data analyst will remain blinded to treatment assignments during data processing and analysis to minimize bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two-arm parallel randomized controlled trial

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: January 22, 2026
• Study Start: December 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)