Lingze tablets plus tamsulosin to improve sleep and nighttime urination after prostate enucleation
A Clinical Observation Study of a Chinese Patent Medicine Combined With Tamsulosin in Improving Sleep and Nocturia Symptoms After Enucleation of the Prostate
We will test whether adding the herbal Lingze tablets to tamsulosin helps men 50 and older who still wake two or more times per night to urinate after HoLEP.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 136 (estimated) |
| Ages | 50 Years and up |
| Sex | Male |
| Sponsor | The Fourth Affiliated Hospital of Zhejiang University School of Medicine Academic / other |
| Locations | 1 site (Yiwu, Zhejiang) |
| Trial ID | NCT07357324 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Men aged 50 or older who have undergone HoLEP, have at least two episodes of nocturia per night, documented bladder outlet obstruction, and can give informed consent and attend follow-up visits are ideal candidates.
Not a fit: Patients with severe active cancer, serious multi-organ failure, known intolerance to the study medications, significant cognitive impairment, or nocturia driven primarily by non-urologic causes (for example uncontrolled heart failure or sleep disorders) are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If effective, adding Lingze tablets to tamsulosin could reduce nighttime urination and improve sleep and quality of life for men who remain symptomatic after prostate enucleation.
How similar studies have performed: Small prior studies of Lingze or related Chinese patent medicines have reported symptom improvements, but combining Lingze with tamsulosin in post-HoLEP patients is novel and not previously proven.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Yiwu, Zhejiang
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.