Ureteral Stent-Related SymptomNCT05598710
Ureteral Stent Related Lower Urinary Tract Symptoms- A Comparative Study
An observational study of Ureteral Stent-Related Symptom, run by National and Kapodistrian University of Athens at 1 site in Greece.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Ureteral Stent-Related Symptom
- What is being tested?
- Pigtail Insertion
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteGreece
- Study dates
- 1 Sep 2021to 15 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with inserted pigtails due to ureteral obstruction or due to procedures such as URS, RIRS and PCNL
Who may be able to join
- Patients with inserted pigtails
Who cannot join
- Mental disorder
- Ureteral obstruction due to malignant disease
- Patients with LUTS due to benign prostatic hyperplasia(BPH)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Ureteral Stent-Related Symptom
- Being tested
- Pigtail Insertion
- Keywords
- pigtail, ureteral stent, USSQ, pigtail size, pigtail length, LUTS, hematuria, pain, sexual performance, daily activity, professional performance
- Medical subject headings
- Hematuria, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pigtail InsertionProcedure or surgery
Pigtail is inserted for any reason of ureteral obstruction except for malignant
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Group who have pigtail 5-26 Receives: Procedure: Pigtail Insertion | |
| Group 2 | Group who have pigtail 6-26 Receives: Procedure: Pigtail Insertion | |
| Group 3 | Group who have pigtail 5-28 Receives: Procedure: Pigtail Insertion | |
| Group 4 | Group who have pigtail 6-28 Receives: Procedure: Pigtail Insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of Ureteral Stent related symptoms with pigtail physical characteristics
Correlation of Ureteral Stent related symptoms with pigtail physical characteristics
Measured: 2 years
Secondary outcomes (1)
Correlation of Ureteral Stent related symptoms with patients characteristics (height)
Correlation of Ureteral Stent related symptoms with patients characteristics (height)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study start1 Sep 2021
- Primary completion15 Sep 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Ureteral Stent-Related SymptomStudies of the same condition, open and under way.
- More trials run by National and Kapodistrian University of AthensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bellos Themistoklis, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05598710
- Sponsor's protocol ID
- 14778
- Status last verified
- Nov 2023
- First submitted
- 25 Oct 2022
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 731804Beiko DT, Knudsen BE, Denstedt JD. Advances in ureteral stent design. J Endourol. 2003 May;17(4):195-9. doi: 10.1089/089277903765444294.
PubMed 12816579Hepperlen 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.
PubMed 77917Gibbons 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.
PubMed 4823967Mardis HK, Hepperlen TW, Kammandel H. Double pigtail ureteral stent. Urology. 1979 Jul;14(1):23-6. doi: 10.1016/0090-4295(79)90205-x.
PubMed 452213Lam 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.
PubMed 12542876Dellis 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.
PubMed 20723923Liu 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.
PubMed 27846839Giannarini 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.
PubMed 20590539Cubuk 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.
PubMed 30527204Thomas 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.
PubMed 8518826Ahallal 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.
PubMed 20811552Betschart 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.
PubMed 28236323
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ureteral Stent Related Lower Urinary Tract Symptoms- A Comparative Study
- ClinicalTrials.gov ID
- NCT05598710
- Acronym / sponsor ID
- 14778
- Conditions
- Ureteral Stent-Related Symptom
- Keywords
- pigtail, ureteral stent, USSQ, pigtail size, pigtail length, LUTS, hematuria, pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 28 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Procedure: Pigtail InsertionGroup who have pigtail 5-26 |
| Group 2 | – | Procedure: Pigtail InsertionGroup who have pigtail 6-26 |
| Group 3 | – | Procedure: Pigtail InsertionGroup who have pigtail 5-28 |
| Group 4 | – | Procedure: Pigtail InsertionGroup who have pigtail 6-28 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with inserted pigtails due to ureteral obstruction or due to procedures such as URS, RIRS and PCNL
Key inclusion criteria (1 listed)
- Patients with inserted pigtails
Key exclusion criteria (3 listed)
- Mental disorder
- Ureteral obstruction due to malignant disease
- Patients with LUTS due to benign prostatic hyperplasia(BPH)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pigtail InsertionPigtail is inserted for any reason of ureteral obstruction except for malignant | Procedure or surgery | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
Correlation of Ureteral Stent related symptoms with pigtail physical characteristics
Time frame: 2 years
Correlation of Ureteral Stent related symptoms with pigtail physical characteristics
1 secondary outcome
Correlation of Ureteral Stent related symptoms with patients characteristics (height)
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Results publication: PubMed 731804Finney 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.
- Results publication: PubMed 12816579Beiko DT, Knudsen BE, Denstedt JD. Advances in ureteral stent design. J Endourol. 2003 May;17(4):195-9. doi: 10.1089/089277903765444294.
- Results publication: PubMed 77917Hepperlen 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.
- Results publication: PubMed 4823967Gibbons 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.
- Results publication: PubMed 452213Mardis HK, Hepperlen TW, Kammandel H. Double pigtail ureteral stent. Urology. 1979 Jul;14(1):23-6. doi: 10.1016/0090-4295(79)90205-x.
- Results publication: PubMed 12542876Lam 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.
- Results publication: PubMed 20723923Dellis 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.
- Results publication: PubMed 27846839Liu 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.
- Results publication: PubMed 20590539Giannarini 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.
- Results publication: PubMed 30527204Cubuk 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.
- Results publication: PubMed 8518826Thomas 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.
- Results publication: PubMed 20811552Ahallal 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ureteral Stent-Related Symptom, run by National and Kapodistrian University of Athens at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of Ureteral Stent related symptoms with pigtail physical characteristics (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05598710, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.