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

Sponsor

Avrasya University (Other)

Overall Status

Completed

CT.gov ID

NCT04550559

Collaborator

(none)

149

Enrollment

Location

Arms

25.9

Actual Duration (Months)

5.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Ureteral Calculi Masturbation	Procedure: Endoscopic ureterolitotripsy	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

149 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Evaluation of the Effect of Masturbation on Distal Ureteral Stones: A Prospective Randomized Controlled Study

Actual Study Start Date :

Feb 1, 2018

Actual Primary Completion Date :

Mar 31, 2020

Actual Study Completion Date :

Mar 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group 1 The patients in group 1 were instructed to masturbate at least 3-4 times a week	Procedure: Endoscopic ureterolitotripsy Endoscopic ureterolithotripsy
Other: Group 2 The patients in group 2 were prescribed oral tamsulosin 0.4 mg once daily	Procedure: Endoscopic ureterolitotripsy Endoscopic ureterolithotripsy
No Intervention: Group 3 The patients in group 3 acted as controls and received only standard medical therapy

Arm

Intervention/Treatment

Active Comparator: Group 1

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

Procedure: Endoscopic ureterolitotripsy

Endoscopic ureterolithotripsy

Other: Group 2

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

Procedure: Endoscopic ureterolitotripsy

Endoscopic ureterolithotripsy

No Intervention: Group 3

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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hasan Turgut	Trabzon		Turkey	61000

Sponsors and Collaborators

Avrasya University

Investigators

Principal Investigator: Hasan Turgut, Dr, Avrasya University Health Science Faculty

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hasan Turgut, urolog dr ,Principal Investigator, Avrasya University

ClinicalTrials.gov Identifier:

NCT04550559

Other Study ID Numbers:

masturbation and stone

First Posted:

Sep 16, 2020

Last Update Posted:

Sep 16, 2020

Last Verified:

Sep 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Ureteral Calculi

Ureterolithiasis

Calculi

Study Results

No Results Posted as of Sep 16, 2020