An interventional study of medical expulsive therapy (tamsulosin) and Acupuncture in Ureter Calculi, sponsored by Hitit University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Hitit University · Not applicable, Interventional, and Treatment
Ureteral stones are a common condition, especially small and distal stones, and can cause renal colic pain. Medical expulsive therapy (MET) is widely used to facilitate stone passage. In this prospective, non-randomized, controlled study, the effect of acupuncture administered in addition to MET on the spontaneous passage of ureteral stones will be evaluated. A total of 40 patients with ureteral stones are planned to be included in the study. Patients will be followed in two groups: MET and acupuncture administered in addition to MET. During the ten-day follow-up period, the stone passage rate, time to stone passage, pain severity, and need for analgesic use will be evaluated. The aim of the study is to investigate the effect of adding acupuncture to MET on ureteral stone passage and symptoms.
This study is a prospective, non-randomized, controlled clinical trial designed to evaluate the efficacy of acupuncture administered in addition to medical expulsive therapy (MET) in patients diagnosed with ureteral stones. A total of 40 patients are planned to be included in the study.
Patients will be divided into two groups. Patients in the control group will receive standard medical expulsive therapy. Patients in the intervention group will receive acupuncture administered by a trained practitioner at predetermined standard acupuncture points in addition to the same medical expulsive therapy. Group assignment will not be performed using a randomization method, and the non-randomized method predetermined in the study protocol will be used.
Patients will be followed up for a total of 10 days. During the follow-up period, whether the stone has passed, the time to stone passage, pain severity and the need for analgesic use will be recorded. Stone passage will be confirmed by patient report and, when necessary, appropriate imaging methods.
The primary aim of the study is to evaluate the effect of adding acupuncture to MET on the spontaneous passage of ureteral stones. Secondary assessments will compare the time to stone passage, pain severity and the need for analgesic use. The data obtained will be compared between the two groups using appropriate statistical methods.
50 studies on the registry are indexed under Ureteral Calculi; 14 are open to participants now.
This study's planned enrollment of 40 is below the median of 100 across 42 interventional studies indexed under Ureteral Calculi.
Browse Ureteral Calculi studies →Hitit University is the lead sponsor of 87 studies on the registry; 29 are open to participants now.
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Exclusion Criteria:
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive standard medical expulsive therapy. Treatment will include the use of an alpha blocker (for example tamsulosin) in clinically appropriate patients and analgesic therapy when necessary. This group will not receive acupuncture. Participants will be followed for 10 days to assess stone passage status, time to stone passage, pain level and need for analgesic use.
Drug: medical expulsive therapy (tamsulosin)
Participants will receive standardized acupuncture in addition to standard medical expulsive therapy. Acupuncture will be administered by a trained practitioner at predetermined acupuncture points. Participants will be followed for 10 days to assess stone passage status, time to stone passage, pain level, and need for analgesic use.
Drug: medical expulsive therapy (tamsulosin) · Procedure: Acupuncture
Medical expulsive therapy with tamsulosin will be administered to patients with ureteral stones according to the study protocol. Tamsulosin will be used to facilitate stone passage and reduce ureteral colic symptoms. The treatment will be continued during the 10-day follow-up period.
Acupuncture will be administered as an adjunct to medical expulsive therapy in the intervention group. Acupuncture will be performed by a trained practitioner using predefined acupuncture points according to the study protocol. The intervention will be applied at predetermined intervals during the 10-day follow-up period. Patients will continue to receive standard medical expulsive therapy.
stone passage rate within10 days
the proportion of patientswho achieve spontaneous ureteral stone passage durıng the 10-day follow- up period. stone passage will be confirmed by patient report and, when clinially indicated, by imaging
Time frame: baseline to 10 days after initiation of treatment
Time to ureteral stone expulsion
Time from initiation of medical expulsive therapy to spontaneous ureteral stone expulsion, measured in days.
Time frame: From treatment initiation through 10 days
Change in pain intensity assessed using the Visual Analog Scale (VAS)
Change in pain intensity assessed using the Visual Analog Scale (VAS), with scores ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate greater pain intensity. Pain intensity will be assessed during the 10-day follow-up period.
Time frame: Baseline to 10 days
Analgesic use during follow-up
The amount and frequency of analgesic medication use during the 10-day follow-up period will be compared between the treatment groups.
Time frame: From treatment initiation through 10 day
Treatment-related adverse events
The incidence and type of adverse events associated with medical expulsive therapy and acupuncture during the 10-day follow-up period.
Time frame: From treatment initiation through 10 days
Plan to share: No
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