Clinical trial NCT05598710: Ureteral Stent Related Lower Urinary Tract Symptoms- A Comparative Study
Official title: Ureteral Stent Related Lower Urinary Tract Symptoms- A Comparative Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ureteral Stent-Related Symptom
Keywords: pigtail
ureteral stent
USSQ
pigtail size
pigtail length
LUTS
hematuria
pain
sexual performance
daily activity
professional performance
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
First posted: 2022-10-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Correlation of Ureteral Stent related symptoms with pigtail physical characteristics
timeFrame: 2 years
Secondary outcomes:
measure: Correlation of Ureteral Stent related symptoms with patients characteristics (height)
timeFrame: 2 years
Other outcomes:
Locations:
city: Marathon
country: Greece
facility: Themistoklis Bellos
state: Attica
Study officials:
References:
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