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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 50
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
The Fourth Affiliated Hospital of School of Medicine, and International School of Medicine, International Institutes of Medicine,Zhejiang University
RECRUITING
Yiwu
Contact Information
Primary
Guangyi Huang, MD
patri7k@126.com
15958911425
Time Frame
Start Date: 2024-12-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 136
Treatments
Active_comparator: Tamsulosin Monotherapy Group
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.
Experimental: Lingze Tablets Combined with Tamsulosin Group
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.
Related Therapeutic Areas
Sponsors
Leads: The Fourth Affiliated Hospital of Zhejiang University School of Medicine

This content was sourced from clinicaltrials.gov

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