NCT05598710

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 25, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 28, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2023

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

2 years

First QC Date

October 25, 2022

Last Update Submit

November 9, 2023

Conditions

Ureteral Stent-Related Symptom

Keywords

pigtailureteral stentUSSQpigtail sizepigtail lengthLUTShematuriapainsexual performancedaily activityprofessional performance

Outcome Measures

Primary Outcomes (1)

  • Correlation of Ureteral Stent related symptoms with pigtail physical characteristics

    Correlation of Ureteral Stent related symptoms with pigtail physical characteristics

    2 years

Secondary Outcomes (1)

  • Correlation of Ureteral Stent related symptoms with patients characteristics (height)

    2 years

Study Arms (4)

Group 1

Group who have pigtail 5-26

Procedure: Pigtail Insertion

Group 2

Group who have pigtail 6-26

Procedure: Pigtail Insertion

Group 3

Group who have pigtail 5-28

Procedure: Pigtail Insertion

Group 4

Group who have pigtail 6-28

Procedure: Pigtail Insertion

Interventions

Pigtail InsertionPROCEDURE

Pigtail is inserted for any reason of ureteral obstruction except for malignant

Group 1Group 2Group 3Group 4

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Patients with inserted pigtails

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Themistoklis Bellos

Marathon, Attica, 19007, Greece

Location

Related Publications (13)

  • Finney RP. Experience with new double J ureteral catheter stent. J Urol. 1978 Dec;120(6):678-81. doi: 10.1016/s0022-5347(17)57326-7.

    PMID: 731804RESULT

  • Beiko DT, Knudsen BE, Denstedt JD. Advances in ureteral stent design. J Endourol. 2003 May;17(4):195-9. doi: 10.1089/089277903765444294.

    PMID: 12816579RESULT

  • Hepperlen TW, Mardis HK, Kammandel H. Self-retained internal ureteral stents: a new approach. J Urol. 1978 Jun;119(6):731-4. doi: 10.1016/s0022-5347(17)57613-2.

    PMID: 77917RESULT

  • Gibbons RP, Mason JT, Correa RJ Jr. Experience with indwelling silicone rubber ureteral catheters. J Urol. 1974 May;111(5):594-9. doi: 10.1016/s0022-5347(17)60023-5. No abstract available.

    PMID: 4823967RESULT

  • Mardis HK, Hepperlen TW, Kammandel H. Double pigtail ureteral stent. Urology. 1979 Jul;14(1):23-6. doi: 10.1016/0090-4295(79)90205-x.

    PMID: 452213RESULT

  • Lam JS, Gupta M. Tips and tricks for the management of retained ureteral stents. J Endourol. 2002 Dec;16(10):733-41. doi: 10.1089/08927790260472881.

    PMID: 12542876RESULT

  • Dellis A, Joshi HB, Timoney AG, Keeley FX Jr. Relief of stent related symptoms: review of engineering and pharmacological solutions. J Urol. 2010 Oct;184(4):1267-72. doi: 10.1016/j.juro.2010.06.043. Epub 2010 Aug 17.

    PMID: 20723923RESULT

  • Liu Q, Liao B, Zhang R, Jin T, Zhou L, Luo D, Liu J, Li H, Wang K. Combination therapy only shows short-term superiority over monotherapy on ureteral stent-related symptoms - outcome from a randomized controlled trial. BMC Urol. 2016 Nov 15;16(1):66. doi: 10.1186/s12894-016-0186-y.

    PMID: 27846839RESULT

  • Giannarini G, Keeley FX Jr, Valent F, Manassero F, Mogorovich A, Autorino R, Selli C. Predictors of morbidity in patients with indwelling ureteric stents: results of a prospective study using the validated Ureteric Stent Symptoms Questionnaire. BJU Int. 2011 Feb;107(4):648-54. doi: 10.1111/j.1464-410X.2010.09482.x.

    PMID: 20590539RESULT

  • Cubuk A, Yanaral F, Ozgor F, Savun M, Ozdemir H, Erbin A, Yuksel B, Sarilar O. Comparison of 4.8 Fr and 6 Fr ureteral stents on stent related symptoms following ureterorenoscopy: A prospective randomized controlled trial. Kaohsiung J Med Sci. 2018 Dec;34(12):695-699. doi: 10.1016/j.kjms.2018.07.001. Epub 2018 Jul 21.

    PMID: 30527204RESULT

  • Thomas R. Indwelling ureteral stents: impact of material and shape on patient comfort. J Endourol. 1993 Apr;7(2):137-40. doi: 10.1089/end.1993.7.137.

    PMID: 8518826RESULT

  • Ahallal Y, Khallouk A, El Fassi MJ, Farih MH. Risk factor analysis and management of ureteral double-j stent complications. Rev Urol. 2010 Spring;12(2-3):e147-51.

    PMID: 20811552RESULT

  • Betschart P, Zumstein V, Piller A, Schmid HP, Abt D. Prevention and treatment of symptoms associated with indwelling ureteral stents: A systematic review. Int J Urol. 2017 Apr;24(4):250-259. doi: 10.1111/iju.13311. Epub 2017 Feb 25.

    PMID: 28236323RESULT

MeSH Terms

Conditions

HematuriaPain

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Urology Intern

Study Record Dates

First Submitted

October 25, 2022

First Posted

October 28, 2022

Study Start

September 1, 2021

Primary Completion

September 15, 2023

Study Completion

September 15, 2023

Last Updated

November 13, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)