Lower Urinary Tract Symptoms, Overactive Bladder Syndrome
Conditions
Keywords
Ureteral stent, OAB
Brief summary
This is a prospective randomized clinical trial, evaluating the effect of the intra-ureteral placement of the stent's distal end versus the conventional stent placement on the postoperative LUTS and pain.
Detailed description
Intravesical stent mass has been considered to cause stent-related symptoms, such as LUTS and pain. The current study hypothesized that the total intra-ureteral placement of the stent's distal end could decrease postoperative LUTS and pain. We proposed a prospective randomized trials, investigating the effect of intra-ureteral stent placement versus conventional stent placement. The primary end point was postoperative LUTS. The secondary end points were postoperative pain and quality of life. We used USSQ questionnaire as the assessing tool.
Interventions
DEVICEUreteral Stent of 5-16 or 5-18
Boston Scientific Polaris™ Ultra Ureteral Stent
DEVICEUreteral Stent of 5-22 or 5-24
Boston Scientific Polaris™ Ultra Ureteral Stent
Sponsors
Taipei Medical University Shuang Ho Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
Patients were not informed the allocation until the stent was removed.
Intervention model description
Arm 1: Intra-ureteral placement of double-J stent Arm 2: Conventional placement of double-J stent
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* Clinical diagnosis of unilateral ureteral stone * Plan to undergo unilateral URS lithotripsy * Adult patients (\>18 years old)
Exclusion criteria
* Pre-stented cases * Distal ureteral stones * Preoperative urinary tract infection * With medications known to influence stent-related symptoms, including alpha-blockers, antimuscarinics, beta3-agonist * Pregnancy * Other procedures required during the procedure of lithotripsy * A stent was expected to be indwelled for more than 10 days (ureteral stricture, ureteral tumors/polyps, ureteral trauma, and a large amount of stone fragments)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lower urinary tract symptom after placement of D-J stent | Before removal of D-J stent | The symptoms are evaluated by a complete USSQ (Ureteral Stent Symptom Questionnaire) urinary index. The minimum and maximum values are 11 and 53, and the higher scores mean a worse outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain after placement of D-J stent | Before removal of D-J stent | The symptoms are evaluated by a complete USSQ (Ureteral Stent Symptom Questionnaire) pain index and general health index. The minimum and maximum values of the body pain index are 2 and 43. The minimum and maximum values of the general health index are 4 and 28. The higher scores of both mean a worse outcome. |
Countries
Taiwan
Outcome results
None listed