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

September 15, 2020 updated by: Hasan Turgut, Avrasya University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

149

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Trabzon, Turkey, 61000
        • Hasan Turgut

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The rates of spontaneous distal ureteral stone (5-10 mm size) passage after 4 weeks masturbation
Time Frame: 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.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Avrasya University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2018

Primary Completion (Actual)

March 31, 2020

Study Completion (Actual)

March 31, 2020

Study Registration Dates

First Submitted

September 1, 2020

First Submitted That Met QC Criteria

September 15, 2020

First Posted (Actual)

September 16, 2020

Study Record Updates

Last Update Posted (Actual)

September 16, 2020

Last Update Submitted That Met QC Criteria

September 15, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • masturbation and stone

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ureteral Calculi

Clinical Trials on Endoscopic ureterolitotripsy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe