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

Not Applicable

Completed

• Conditions: Ureteral Calculi; Masturbation
• Interventions: Procedure: Endoscopic ureterolitotripsy

• Registration Number: NCT04550559
• Lead Sponsor: Avrasya University

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.

Study Timeline

• Study Start: 2018-02-01
• Primary Completion: 2020-03-31
• Study Completion: 2020-03-31
• Status Verified: 2020-09
• Study First Submitted: 2020-09-01
• Study First Submitted QC: 2020-09-15
• Last Update Submitted: 2020-09-15
• Study First Posted: 2020-09-16
• Last Update Posted: 2020-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 149

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	Endoscopic ureterolitotripsy	The patients in group 2 were prescribed oral tamsulosin 0.4 mg once daily
Group 1	Endoscopic ureterolitotripsy	The patients in group 1 were instructed to masturbate at least 3-4 times a week

Primary Outcome Measures

Name	Time	Method
The rates of spontaneous distal ureteral stone (5-10 mm size) passage after 4 weeks masturbation	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.

Trial Locations

Locations (1)

Hasan Turgut; 🇹🇷 Trabzon, Turkey