Ureteral Stent Related Lower Urinary Tract Symptoms- A Comparative Study

November 9, 2023 updated by: Bellos Themistoklis, National and Kapodistrian University of Athens

Pigtails are inserted to relieve of pelviureteral system independent of the underlying cause. Pain, Lower Urinary Tract Symptoms (LUTS), hematuria and fever can be some of the early complications after their insertion..More than 80% of the patients mention significant amount of pain limiting their daily activities while 78% mentions LUTS.

The local irritation from the pigtail in the kidney and the ureterovesical junction, the urine reflux through the pigtail, length and size of the pigtail are some of the factors that account for the Ureteral Stent Related Symptoms (USRS) .Important role also has the length of remaining pigtail within the bladder as well as the drainage capacity,the lack of elasticity and the migration within the bladder of the pigtail .Aim of this study is to correlate the physical properties of the pigtail (length,size) with the complications after the insertion.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Ureteral stents were first described by Finney and Hepperlen. Stenting of the upper urinary tract was initially used for relieving upper urinary tract obstruction and for ureteral alignment. The first self retaining ureteral catheters were described by Gibbons , Mardis , Finney and Hepperlen. Ureteral stents can be either open -end or close- end. The main materials used for manufacturing them are silicone, polyurethane and Percuflex.

Pigtail are placed to prevent ureteral obstruction from stone fragments, ureteral oedema, hepatoma, as well as to prevent urinomas.Some of the factors that influence Ureteral Stent Related Symptoms ( USSQ) are the irritation to the kidney and bladder trigone, the vesicoureteral reflux through the pigtail ,pigtail length and the remaining tail length within the bladder.Early complications after pigtail insertion include pain, LUTS (lower urinary tract symptoms )[ increased frequency (60%), hesitancy (60%) ,dysuria (40%)] , renal pain ,body pain, hematuria (54%) and fever. More than 80% of the patients mention pain limiting their daily activities while 78% mentions LUTS. Late complications following pigtail insertion include pigtail migration , renal obstruction , stone formation around the pigtail and automatic pigtail degradation.Pigtail can also affect sexual and professional life.

The purpose of this survey is to clarify the connection between the pigtail physical properties (length, size) with the complications arising from their use.The goal is to investigate if the use of one type of ureteral stent with particular characteristics is better than the others and the use of this knowledge in everyday clinical praxis.

In this survey will be included patients with inserted pigtails. In our clinic we have access to pigtail sizes 6 Fr 26 cm, 5 Fr 26 cm,6 Fr 28 cm και 5 Fr 28 cm.The patients will be divided into 4 groups depending on the pigtail size. All the patients will have signed a consent form prior to their inclusion in the study. Patients having pigtail due to malignant disease and patients not being in the mental state to cooperate will be excluded from this survey. The pigtail insertion will be correlated with the potential complications using the Ureteral Stent Related Symptoms Questionnaire ( USSQ) which was first described by Joshi in 2003. This questionnaire is answered by each patient the first and fourth week of pigtail insertion and the fourth week after pigtail removal. It includes questions covering six fields: urinary tract symptoms, body pain, overall health, professional performance , sexual performance and additional problems.

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Greece
    • Attica
      • Marathon, Attica, Greece, 19007
        • Themistoklis Bellos

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

16 years to 98 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with inserted pigtails due to ureteral obstruction or due to procedures such as URS, RIRS and PCNL

Description

Inclusion Criteria:

  • Patients with inserted pigtails

Exclusion Criteria:

  • Mental disorder
  • Ureteral obstruction due to malignant disease
  • Patients with LUTS due to benign prostatic hyperplasia(BPH)

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Group who have pigtail 5-26
Procedure: Pigtail Insertion
Pigtail is inserted for any reason of ureteral obstruction except for malignant
Group 2
Group who have pigtail 6-26
Procedure: Pigtail Insertion
Pigtail is inserted for any reason of ureteral obstruction except for malignant
Group 3
Group who have pigtail 5-28
Procedure: Pigtail Insertion
Pigtail is inserted for any reason of ureteral obstruction except for malignant
Group 4
Group who have pigtail 6-28
Procedure: Pigtail Insertion
Pigtail is inserted for any reason of ureteral obstruction except for malignant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of Ureteral Stent related symptoms with pigtail physical characteristics
Time Frame: 2 years
Correlation of Ureteral Stent related symptoms with pigtail physical characteristics
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of Ureteral Stent related symptoms with patients characteristics (height)
Time Frame: 2 years
Correlation of Ureteral Stent related symptoms with patients characteristics (height)
2 years

Collaborators and Investigators

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

Sponsor

National and Kapodistrian University of Athens

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

September 1, 2021

Primary Completion (Actual)

September 15, 2023

Study Completion (Actual)

September 15, 2023

Study Registration Dates

First Submitted

October 25, 2022

First Submitted That Met QC Criteria

October 25, 2022

First Posted (Actual)

October 28, 2022

Study Record Updates

Last Update Posted (Estimated)

November 13, 2023

Last Update Submitted That Met QC Criteria

November 9, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14778

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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