A study to compare the ureteral stent with two loops with one loop ureteral stent after ureteroscopy in terms of stent related symptoms
- Conditions
- Urinary calculus, unspecified,
- Registration Number
- CTRI/2020/02/023191
- Lead Sponsor
- Kasturba Medical College and Hospital
- Brief Summary
1. Title of the project : A Randomized, Prospective Study to compare the Efficacyand Safety of Complete Intraureteral Stent Placement versus Conventional StentPlacement in Relieving Ureteral Stent Related Symptoms
2. Type of Study : Randomized, Prospective, single center study
3. Aims & objectives: -To compare the Efficacy andSafety of Complete Intraureteral Stent Placement versus Conventional StentPlacement in Relieving Ureteral Stent Related Symptoms-To study the poststenting ureteral symptom score in patients having undergone completeIntraureteral Stent Placement and Conventional Stent Placement
4. Justification for study:- More than 80% of urologistsroutinelyplace ureteral stents afterUreteroscopyfor urolithiasis toreducepostoperative complications.-Stent related discomfort,including pain or urinarysymptoms, is considered to be caused by ureteral spasm or trigonalirritationdue to the presence of stents.-Agents such asantimuscarinic drugs or alpha-1 blockers are used to improve these symptoms.However, these drugs areassociated with sideeffects and they cannot be easily administered in patients with comorbidities.-The concept of reducing the stent related symptoms usingnovel stents and without using drugs seems convincing. However, well-designedstudies are missing and no conclusion can be drawn in terms of potentially lower morbidity.-Therefore, need of this study is toknow whether complete intraureteral stent, in which the distal end of the ureteralstent is placed proximal tothe ureteral orifice, would more effectively relieve stent relateddiscomfort than conventional stent placement, in which the distal end oftheureteral stent is placed atthe bladder. 5. Departments involved : Department Of Urology andRenal Transplant
6. Study period : September 2019 to October 2019
7. Sample size : 100 cases 8. Materials and methods :
**Inclusion criteria**
Adult patients 18 years old or older who needunilateral ureteroscopy for urolithiasis with planned ureteral stent insertion(stone breaking/removal by inserting scope in the ureter and inserting a pipefrom kidney to the bladder) are eligible for study.
**Exclusion criteria**
Patients having 1) distal ureteralstones (stones below the sacroiliac joint on NCCT KUB)
2) preoperative ureteral stenting (inserting stent before procedure)
3) pregnancy or breast feeding
4) bilateral URS surgery (ureteroscopyon both sides)
5) a solitary kidney ( only one kidney)
6) a potential requirement for a ureteralstent more than 14 days postoperatively ( required to keep stent for more than14 days)
7) difficulty in obtaining consent orother issues such as rating the degree of pain
b)Biological materials required (type - blood, tissue etc and quantity) : Nil
Detaileddescription of procedure / processes :
-The present study shall be conducted on 100cases diagnosed with ureteric calculus getting admitted to Kasturba MedicalCollege, Manipal
-Patients shall be selected for studyaccording to the inclusion and exclusion criteria
-The purpose of the study will be explained tothe patient and informed consent will be obtained for collection of data inpatient’s own vernacular language.
-Patients will be randomized into 2 groups byusing computer generated randomization, as per group 1 and 2.
-As per the standard of care a detailedhistory, clinical, laboratory and imaging data of these patients at admissionand then on daily basis will be recorded as per proforma
-Group 1 will undergo standard conventional stentplacement under cystoscopic or fluoroscopic guidance after ureteroscopy isperformed for urolithiasis and group 2will undergo placement of complete intra ureteral stents with extractionstrings at the end which will also be under cystoscopic or fluoroscopicguidance.
-Ureteroscpoy for stone disease shall be performed with rigid/semi-rigidureteroscope of size 6/7.5 Fr or 8/9.8 Fr for patients of both the groups.
-After URS a conventional ureteral stent without string (a 5Fr, 18 cm/6Fr, 20cm/6Fr, 22 cm/6Fr or 24 cm/6fr or 26cm/6Fr BLUENEEM STENTS) or completeintraureteral stents with string shall be inserted under cystoscopic orfluoroscopic guidance according to actual ureteral length in group 1 and group2 respectively.The accuracy of the correct stent location will be confirmed bycystoscopy and fluoroscopy at surgery.
-Both group patients shall be provided these stents free of cost.
Finallythe stent string will be cut approximately 10 cm from the tip of the urethra.
-Intraoperativedata shall be collected as per proforma.
-Onpost-operative day 2 patient shall be asked to fill the Ureteral stent symptomscore questionnaire ( English/ Kannada)
-Patient shall be asked to follow up after 2 weeks on post op day 14 for stentremoval where he/she shall be asked to fill the questionnaire again beforeextraction of the stent.
-Patient shall also undergo X-ray KUB before stent removal to know the positionof stent as per standard routine protocol.
- Based on the Questionnaire filled by patients we shall assess thesafety and efficacy of the complete intra ureteral stent in terms of stentrelated symptoms in comparison to conventional stent .
10. Outcome measures : Comparing the efficacy of conventional stent andcomplete intraureteral stent in lowering stent related symptoms .
11. Potential risks and benefits***:***
Risks: The risks associated with usingconventional stents may be pain, increased frequency of micturition,incontinence, retention of urine, dysuria, fever, hematuria, urinary tractinfection which may be more than those associated with complete intraureteralstenting. Both the groups carry the same risk however the intra ureteralstents have shown to have lesser risk.
- In patients with completeintraureteral stent placement, there will be a string hanging out of the urethrawhich can be used to pull the stent out at the time of stent removal. The maybe associated risk of accidental pull out of stent or migration of stentassociated with this group.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 100
Adult patients 18 years old or older who need unilateral ureteroscopy for urolithiasis with planned ureteral stent insertion.
Patients having 1) distal ureteral stones (stones below the sacroiliac joint on NCCT KUB) 2) preoperative ureteral stenting ( inserting stent before procedure) 3) pregnancy or breast feeding 4) bilateral URS surgery (ureteroscopy on both sides) 5) a solitary kidney ( only one kidney) 6) a potential requirement for a ureteral stent more than 14 days postoperatively ( required to keep stent for more than 14 days) 7) difficulty in obtaining consent or other issues such as rating the degree of pain.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the Efficacy and Safety of Complete Intraureteral Stent Placement versus Conventional Stent Placement in Relieving Ureteral Stent Related Symptoms 14 days( 2 weeks)
- Secondary Outcome Measures
Name Time Method To study the post stenting ureteral symptom score in patients having undergone complete Intraureteral Stent Placement and Conventional Stent Placement USSQ score checked at time of stent removal at 2 weeks
Trial Locations
- Locations (1)
Kasturba Medical College and Hospital
🇮🇳Udupi, KARNATAKA, India
Kasturba Medical College and Hospital🇮🇳Udupi, KARNATAKA, IndiaMilap ShahPrincipal investigator08141200532drmilapshah@gmail.com