Ureteral Stent Related Lower Urinary Tract Symptoms- A Comparative Study

NCT ID: NCT05598710

Last Updated: 2023-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-01

Study Completion Date

2023-09-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Ureteral Stent-Related Symptom

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Group who have pigtail 5-26

Pigtail Insertion

Intervention Type PROCEDURE

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

Group 2

Group who have pigtail 6-26

Pigtail Insertion

Intervention Type PROCEDURE

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

Group 3

Group who have pigtail 5-28

Pigtail Insertion

Intervention Type PROCEDURE

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

Group 4

Group who have pigtail 6-28

Pigtail Insertion

Intervention Type PROCEDURE

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

Interventions

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Pigtail Insertion

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

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National and Kapodistrian University of Athens

OTHER

Sponsor Role lead

Responsible Party

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Bellos Themistoklis

Urology Intern

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Themistoklis Bellos

Marathon, Attica, Greece

Site Status

Countries

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Greece

References

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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.

Reference Type RESULT
PMID: 731804 (View on PubMed)

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

Reference Type RESULT
PMID: 12816579 (View on PubMed)

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.

Reference Type RESULT
PMID: 77917 (View on PubMed)

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.

Reference Type RESULT
PMID: 4823967 (View on PubMed)

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.

Reference Type RESULT
PMID: 452213 (View on PubMed)

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.

Reference Type RESULT
PMID: 12542876 (View on PubMed)

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.

Reference Type RESULT
PMID: 20723923 (View on PubMed)

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.

Reference Type RESULT
PMID: 27846839 (View on PubMed)

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.

Reference Type RESULT
PMID: 20590539 (View on PubMed)

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.

Reference Type RESULT
PMID: 30527204 (View on PubMed)

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.

Reference Type RESULT
PMID: 8518826 (View on PubMed)

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.

Reference Type RESULT
PMID: 20811552 (View on PubMed)

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.

Reference Type RESULT
PMID: 28236323 (View on PubMed)

Other Identifiers

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14778

Identifier Type: -

Identifier Source: org_study_id

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