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

NCT04550559 | Completed

• 1 other identifier: masturbation and stone
• Study Type: interventional
• Target: 149
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the effect of masturbation on the spontaneous expulsion of distal ureteral stones 5-10 mm in size.

Conditions

Ureteral Calculi; Masturbation

Outcome Measures

Primary Outcomes (1)

• 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.

  4 weeks

Study Arms (3)

Group 1

ACTIVE COMPARATOR

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

Procedure: Endoscopic ureterolitotripsy

Group 2

OTHER

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

Procedure: Endoscopic ureterolitotripsy

Group 3

NO INTERVENTION

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

Interventions

Endoscopic ureterolitotripsy PROCEDURE

Endoscopic ureterolithotripsy

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Avrasya University: lead

Study Sites (1)

Hasan Turgut

Trabzon, 61000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Ureteral Calculi; Masturbation

Condition Hierarchy (Ancestors)

Ureterolithiasis; Ureteral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Sexual Behavior; Behavior

Study Officials

• Hasan Turgut, Dr

  Avrasya University Health Science Faculty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: urolog dr ,Principal Investigator

Study Record Dates

• First Submitted: September 1, 2020
• First Posted: September 16, 2020
• Study Start: February 1, 2018
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: September 16, 2020

Record last verified: 2020-09

Locations

TU (1)