Ureteral CalculiNCT04550559
Rate of Spontaneous Stone Passage as Assessed Using Urinary Ultrasonography and Direct Urinary System Radiography
A study testing Endoscopic ureterolitotripsy in people with Ureteral Calculi and Masturbation, run by Avrasya University at 1 site in Turkey (Türkiye).
Trial summary
To evaluate the effect of masturbation on the spontaneous expulsion of distal ureteral stones 5-10 mm in size. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Ureteral Calculi, Masturbation
- What is being tested?
- Endoscopic ureterolitotripsy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2018to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age ≥18 years
- presenting with renal colic and inguinal or lumbar pain
- being diagnosed as having distal ureteral stones ≥5 mm and <10 mm in size
Who cannot join
- age <18 years,
- stones <5 mm or ≥10 mm in size,
- intermediate (stones on the ureter-iliac artery cross)
- proximal ureteral stones, multiple ureteral stones,
- presence of urinary infection,
- renal insufficiency,
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- high creatinine level,
- severe hydroureteronephrosis,
- history of open or endoscopic ureteral surgery,
- vesicoureteral reflux,
- neurogenic bladder,
- erectile dysfunction,
- inability or refusal to masturbate for any reason (such as religious beliefs)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of Masturbation on Distal Ureteral Stones: A Prospective Randomized Controlled Study
To evaluate the effect of masturbation on the spontaneous expulsion of distal ureteral stones 5-10 mm in size.
Read the detailed description
This prospective randomized controlled study was performed between February 2018 and March 2020 after obtaining ethics committee approval.A total of 128 men with distal ureteral stones were randomly divided into 3 groups. All patients received standard medical therapy. Patients in group 1 (n=43) were instructed to masturbate at least 3-4 times a week, patients in group 2 (n=41) received tamsulosin 0.4 mg/day, and patients in group 3 (controls, n=44) received standard medical therapy alone. Rates of expulsion, need for analgesic, and ureterorenoscopic lithotripsy were compared between the groups.
- Conditions
- Ureteral Calculi, Masturbation
- Being tested
- Endoscopic ureterolitotripsy
- Medical subject headings
- Ureteral Calculi, Masturbation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic ureterolitotripsyProcedure or surgery
Endoscopic ureterolithotripsy
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | The patients in group 1 were instructed to masturbate at least 3-4 times a week Receives: Procedure: Endoscopic ureterolitotripsy |
| Group 2 | Other | The patients in group 2 were prescribed oral tamsulosin 0.4 mg once daily Receives: Procedure: Endoscopic ureterolitotripsy |
| Group 3 | No intervention | The patients in group 3 acted as controls and received only standard medical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rates of spontaneous distal ureteral stone (5-10 mm size) passage after 4 weeks masturbation
The rates of spontaneous distal ureteral stone (5-10 mm size) passage of patients who were instructed to masturbate at least 3-4 times a week (Group1); received tamsulosin 0.4 mg/day (Group2); received standard medical therapy alone Group3.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start1 Feb 2018
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ureteral 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avrasya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasan Turgut, Avrasya University
- Investigators
- Hasan Turgut, Dr, Principal investigator, Avrasya University Health Science Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04550559
- Sponsor's protocol ID
- masturbation and stone
- Status last verified
- Sep 2020
- First submitted
- 1 Sep 2020
- Last updated
- 16 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Masturbation on Distal Ureteral Stones: A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04550559
- Acronym / sponsor ID
- masturbation and stone
- Conditions
- Ureteral Calculi, Masturbation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Avrasya UniversityUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 16 Sep 2020 (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.
To evaluate the effect of masturbation on the spontaneous expulsion of distal ureteral stones 5-10 mm in size.
Detailed description
This prospective randomized controlled study was performed between February 2018 and March 2020 after obtaining ethics committee approval.A total of 128 men with distal ureteral stones were randomly divided into 3 groups. All patients received standard medical therapy. Patients in group 1 (n=43) were instructed to masturbate at least 3-4 times a week, patients in group 2 (n=41) received tamsulosin 0.4 mg/day, and patients in group 3 (controls, n=44) received standard medical therapy alone. Rates of expulsion, need for analgesic, and ureterorenoscopic lithotripsy were compared between the groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Procedure: Endoscopic ureterolitotripsyThe patients in group 1 were instructed to masturbate at least 3-4 times a week |
| Group 2 | Other | Procedure: Endoscopic ureterolitotripsyThe patients in group 2 were prescribed oral tamsulosin 0.4 mg once daily |
| Group 3 | No intervention | –The patients in group 3 acted as controls and received only standard medical therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age ≥18 years
- presenting with renal colic and inguinal or lumbar pain
- being diagnosed as having distal ureteral stones ≥5 mm and <10 mm in size
Key exclusion criteria (13 listed)
- age <18 years,
- stones <5 mm or ≥10 mm in size,
- intermediate (stones on the ureter-iliac artery cross)
- proximal ureteral stones, multiple ureteral stones,
- presence of urinary infection,
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 |
|---|---|---|
| Endoscopic ureterolitotripsyEndoscopic ureterolithotripsy | Procedure or surgery | Group 1, Group 2 |
Primary outcome
The rates of spontaneous distal ureteral stone (5-10 mm size) passage after 4 weeks masturbation
Time frame: 4 weeks
The rates of spontaneous distal ureteral stone (5-10 mm size) passage of patients who were instructed to masturbate at least 3-4 times a week (Group1); received tamsulosin 0.4 mg/day (Group2); received standard medical therapy alone Group3.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
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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. This study is not recruiting at the moment.
Hasan Turgut, Dr principal investigator
Avrasya University Health Science Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic ureterolitotripsy in people with Ureteral Calculi and Masturbation, run by Avrasya 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 3 inclusion and 13 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: finished, as of the sponsor's last update on 16 Sep 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rates of spontaneous distal ureteral stone (5-10 mm size) passage after 4 weeks masturbation (time frame: 4 weeks). 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 16 Sep 2020.