NCT07357324 A Clinical Observation Study of a Chinese Patent Medicine Combined With Tamsulosin in Improving Sleep and Nocturia Symptoms After Enucleation of the Prostate
| NCT ID | NCT07357324 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | The Fourth Affiliated Hospital of Zhejiang University School of Medicine |
| Condition | Benign Prostatic Hyperplasia |
| Study Type | INTERVENTIONAL |
| Enrollment | 136 participants |
| Start Date | 2024-12-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 136 participants in total. It began in 2024-12-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07357324 clinical trial?
This trial is open to male participants only, aged 50 Years or older, studying Benign Prostatic Hyperplasia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07357324 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07357324 currently recruiting?
Yes, NCT07357324 is actively recruiting participants. Contact the research team at patri7k@126.com for enrollment information.
Where is the NCT07357324 trial being conducted?
This trial is being conducted at Yiwu, China.
Who is sponsoring the NCT07357324 clinical trial?
NCT07357324 is sponsored by The Fourth Affiliated Hospital of Zhejiang University School of Medicine. The trial plans to enroll 136 participants.