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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

About this trial

This is an interventional treatment trial for Ureteral Calculi

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Studies a U.S. FDA-regulated Device Product

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

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

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

Learn more about this trial

Rate of Spontaneous Stone Passage as Assessed Using Urinary Ultrasonography and Direct Urinary System Radiography

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