Rate of Spontaneous Stone Passage as Assessed Using Urinary Ultrasonography and Direct Urinary System Radiography
Primary Purpose
Ureteral Calculi, Masturbation
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Endoscopic ureterolitotripsy
Sponsored by
About this trial
This is an interventional treatment trial for Ureteral Calculi
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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,
- 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)
Sites / Locations
- Hasan Turgut
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Other
No Intervention
Arm Label
Group 1
Group 2
Group 3
Arm Description
The patients in group 1 were instructed to masturbate at least 3-4 times a week
The patients in group 2 were prescribed oral tamsulosin 0.4 mg once daily
The patients in group 3 acted as controls and received only standard medical therapy
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04550559
First Posted
September 1, 2020
Last Updated
September 15, 2020
Sponsor
Avrasya University
1. Study Identification
Unique Protocol Identification Number
NCT04550559
Brief Title
Rate of Spontaneous Stone Passage as Assessed Using Urinary Ultrasonography and Direct Urinary System Radiography
Official Title
Evaluation of the Effect of Masturbation on Distal Ureteral Stones: A Prospective Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
March 31, 2020 (Actual)
Study Completion Date
March 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Avrasya University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ureteral Calculi, Masturbation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
149 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
The patients in group 1 were instructed to masturbate at least 3-4 times a week
Arm Title
Group 2
Arm Type
Other
Arm Description
The patients in group 2 were prescribed oral tamsulosin 0.4 mg once daily
Arm Title
Group 3
Arm Type
No Intervention
Arm Description
The patients in group 3 acted as controls and received only standard medical therapy
Intervention Type
Procedure
Intervention Name(s)
Endoscopic ureterolitotripsy
Intervention Description
Endoscopic ureterolithotripsy
Primary Outcome Measure Information:
Title
The rates of spontaneous distal ureteral stone (5-10 mm size) passage after 4 weeks masturbation
Description
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.
Time Frame
4 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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,
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hasan Turgut, Dr
Organizational Affiliation
Avrasya University Health Science Faculty
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hasan Turgut
City
Trabzon
ZIP/Postal Code
61000
Country
Turkey
12. IPD Sharing Statement
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Rate of Spontaneous Stone Passage as Assessed Using Urinary Ultrasonography and Direct Urinary System Radiography
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