Ureter CalculiNCT07893431
The Effect of Acupuncture on Passing Ureteral Stones
A study testing medical expulsive therapy (tamsulosin) and Acupuncture in people with Ureter Calculi, run by Hitit University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Ureter Calculi
- What is being tested?
- medical expulsive therapy (tamsulosin) and Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2026to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged 18-65 years.
- Patients with a radiologically confirmed unilateral ureteral stone.
- Stone size between 3 and 10 mm.
- Patients with a distal or mid-ureteral stone.
- Patients with a clinical condition suitable for conservative treatment.
- Patients who provide written informed consent to participate in the study.
Who cannot join
- Stone size >10 mm or clinical conditions requiring surgical/endoscopic intervention.
- Fever, urinary tract infection, or signs of sepsis.
- Severe hydronephrosis or renal dysfunction.
- Pregnancy.
- Solitary kidney or bilateral urinary tract obstruction.
- Previous intervention for the current ureteral stone.
Show all 9Show fewer
- Bleeding diathesis or anticoagulant therapy that constitutes a contraindication to acupuncture.
- Dermatological or systemic diseases that prevent acupuncture application.
- Patients who are unable to comply with the study protocol or follow-up.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hitit university
Çorum, Çorum, 19030
Mustafa Serdar Caglayan, 05074311951, serdar.09.09@hotmail.com
About this study
Official title: Evaluation of the Effectiveness of Acupuncture Application in Addition to Medical Expulsive Therapy for Ureteral Stones
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.
Read the detailed description
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.
- Conditions
- Ureter Calculi
- Being tested
- medical expulsive therapy (tamsulosin), Acupuncture
- Keywords
- Ureteral calculi, medical expulsive therapy, acupuncture, stone passage, Ureteral stone passage, ureteral stone
- Medical subject headings
- Ureteral Calculi, Ureterolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medical expulsive therapy (tamsulosin)Drug
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.
AcupunctureProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| MET group | Active comparator | 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. Receives: Drug: medical expulsive therapy (tamsulosin) |
| MET + Akupunktur gruoup | Experimental | 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. Receives: Drug: medical expulsive therapy (tamsulosin); Procedure: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline to 10 days after initiation of treatment
Secondary outcomes (4)
Time to ureteral stone expulsion
Time from initiation of medical expulsive therapy to spontaneous ureteral stone expulsion, measured in days.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From treatment initiation through 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start1 Aug 2026
- Primary completion8 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ureter CalculiStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, non-randomized, two-arm, parallel-group controlled clinical trial. One group will receive only medical expulsive therapy, while the other group will receive acupuncture in addition to medical expulsive therapy.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hitit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Serdar CAGLAYAN, Hitit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07893431
- Sponsor's protocol ID
- 2026-09
- Status last verified
- Oct 2026
- First submitted
- 24 Sep 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Acupuncture Application in Addition to Medical Expulsive Therapy for Ureteral Stones
- ClinicalTrials.gov ID
- NCT07893431
- Acronym / sponsor ID
- 2026-09
- Conditions
- Ureter Calculi
- Keywords
- Ureteral calculi, medical expulsive therapy, acupuncture, stone passage, Ureteral stone passage, ureteral stone
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hitit UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- 8 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 26 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, non-randomized, two-arm, parallel-group controlled clinical trial. One group will receive only medical expulsive therapy, while the other group will receive acupuncture in addition to medical expulsive therapy.
| Arm | Type | Receives |
|---|---|---|
| MET group | Active comparator | Drug: medical expulsive therapy (tamsulosin)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. |
| MET + Akupunktur gruoup | Experimental | Drug: medical expulsive therapy (tamsulosin), Procedure: AcupunctureParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients aged 18-65 years.
- Patients with a radiologically confirmed unilateral ureteral stone.
- Stone size between 3 and 10 mm.
- Patients with a distal or mid-ureteral stone.
- Patients with a clinical condition suitable for conservative treatment.
Key exclusion criteria (9 listed)
- Stone size >10 mm or clinical conditions requiring surgical/endoscopic intervention.
- Fever, urinary tract infection, or signs of sepsis.
- Severe hydronephrosis or renal dysfunction.
- Pregnancy.
- Solitary kidney or bilateral urinary tract obstruction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| medical expulsive therapy (tamsulosin)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. | Drug | MET + Akupunktur gruoup, MET group |
| AcupunctureAcupuncture 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. | Procedure or surgery | MET + Akupunktur gruoup |
Primary outcome
stone passage rate within10 days
Time frame: baseline to 10 days after initiation of treatment
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
4 secondary outcomes
Time to ureteral stone expulsion
Time frame: From treatment initiation through 10 days
Change in pain intensity assessed using the Visual Analog Scale (VAS)
Time frame: Baseline to 10 days
Analgesic use during follow-up
Time frame: From treatment initiation through 10 day
Treatment-related adverse events
Time frame: From treatment initiation through 10 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing medical expulsive therapy (tamsulosin) and Acupuncture in people with Ureter Calculi, run by Hitit University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mustafa Serdar Caglayan (05074311951, serdar.09.09@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stone passage rate within10 days (time frame: baseline to 10 days after initiation of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.