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

NCT ID: NCT04550559

Last Updated: 2020-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 149 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-01
• Study Completion Date: 2020-03-31

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.

Conditions

Ureteral Calculi; Masturbation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group 1

The patients in group 1 were instructed to masturbate at least 3-4 times a week

Group Type: ACTIVE_COMPARATOR

Endoscopic ureterolitotripsy

Intervention Type: PROCEDURE

Endoscopic ureterolithotripsy

Group 2

The patients in group 2 were prescribed oral tamsulosin 0.4 mg once daily

Group Type: OTHER

Endoscopic ureterolitotripsy

Intervention Type: PROCEDURE

Endoscopic ureterolithotripsy

Group 3

The patients in group 3 acted as controls and received only standard medical therapy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Endoscopic ureterolitotripsy

Endoscopic ureterolithotripsy

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Avrasya University

OTHER

Sponsor Role: lead

Responsible Party

Hasan Turgut

urolog dr ,Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hasan Turgut, Dr

Role: PRINCIPAL_INVESTIGATOR

Avrasya University Health Science Faculty

Locations

Hasan Turgut

Trabzon, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

masturbation and stone

Identifier Type: -

Identifier Source: org_study_id