Lingze tablets plus tamsulosin to improve sleep and nighttime urination after prostate enucleation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, parallel-group study will enroll about 136 men who remain symptomatic after transurethral holmium laser enucleation of the prostate (HoLEP) and have at least two nightly voids. Participants are assigned to tamsulosin sustained-release capsules alone or tamsulosin plus Lingze tablets for an 8-week treatment period, with follow-up visits and symptom questionnaires. Primary outcomes focus on nocturia frequency, sleep disturbance, and other urinary symptoms, with safety monitoring for medication intolerance and adverse events. Key eligibility includes age ≥50, documented bladder outlet obstruction and postoperative urinary symptoms, while exclusions include severe cancer, multi-organ failure, known drug hypersensitivity, or inability to comply with study procedures.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Where it's running

• The Fourth Affiliated Hospital of School of Medicine, and International School of Medicine, International Institutes of Medicine，Zhejiang University
  Yiwu, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Guangyi Huang, MD
• Email: patri7k@126.com
• Phone: 15958911425

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.