A Randomized Placebo Controlled Trial of Mirabegron on Alleviating Stent-Related Symptoms among Patients with Indwelling Double J Stent

Sirisreetreerux P1, Siantong M1, Pattanaprateep O1

Research Type

Clinical

Abstract Category

Pharmacology

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Abstract 33
Overactive Bladder and Neuromodulation
Scientific Podium Short Oral Session 6
Wednesday 27th September 2023
15:00 - 15:07
Theatre 102
Female Quality of Life (QoL) Clinical Trial Pharmacology Urgency/Frequency
1. Faculty of Medicine Ramathibodi hospital, Mahidol University
Presenter
M

Mookdarat Siantong

Links

Abstract

Hypothesis / aims of study
To evaluate the effects of Mirabegron 50 mg once daily on the stent-related symptoms in patients with indwelling double J stent by conducting a single center, randomized placebo-controlled study in Ramathibodi hospital.
Study design, materials and methods
A total of 49 patients underwent DJ stent insertion or exchange during June 2020 to June 2021 were randomized 1:1 into control ( taking placebo 1 tab once daily ) and treatment group ( Mirabegron 50 mg once daily ) for the duration of 30 days. These patients had their stents inserted due to several reasons: after urologic procedures i.e., Ureteroscopic lithotripsy (URSL) or Retrograde Intrarenal Surgery (RIRS), diverting ureteric obstruction from renal or ureteric calculi, correcting obstructive uropathy from colorectal malignancies, gynecological malignancies, bladder and prostate malignancies, and stenting ureteric strictures from other benign causes. At enrollment dates, both groups took OABSS (Overactive Bladder Symptoms Scores) and EQ5D5L questionnaires, for comparing their baseline urinary symptoms and general health. After one month of drugs administration, the patients then again took EQ5D5L questionnaire and USSQ (Urinary Stent Symptoms Questionnaire). All the questionnaires used are validated and translated into Thai language. The primary outcome is the difference of USSQ scores between the two groups.
Results
Among 49 patients, the median age in control group was 63 years old (P25,P75 = 56, 67.5) and 64 years old (P25,P75 = 50, 70) in treatment group. The genders, BMI, Glomerular filtration rates, underlying diseases including hypertension and diabetes mellitus, pre-intervention systolic and diastolic blood pressures, and the reasons for having stent inserted were the same in both groups. The pre-intervention OABSS and EQ5D5L scores in both groups were also similar. Patients in Mirabegron group responded that there is no difficulty performing light physical activities ( Median(P25, P75) = 1 (1, 1))*  while control group responded that they usually have some difficulty performing light physical activity ( Median (P25, P75) = 2 (1, 2)), with P value of 0.002 after the end of intervention. Both groups have relatively similar urinary symptoms scores, pain scores, work performance scores, sexual performance scores, additional problem scores and post-intervention EQ5D5L scores. Post-intervention systolic and diastolic blood pressures did not differ significantly. One patient (4%)  in Mirabegron group encountered tachycardia and one patient (4%) experienced dry mouth. Both have mild symptoms and could complete taking the medication for the required period of this research.
Interpretation of results
Compared to the control group, the Mirabegron group had significantly better general health symptoms regarding less difficulty in performing light physical activities. No serious side effect was found in Mirabegron group.
Concluding message
Among patients with indwelling double J stent, taking Mirabegron once daily could reduce difficulty in performing light physical activities. Mirabegron performed equally to placebo regarding improving bothersome urinary symptoms and reducing body pain scores in this single center study.
References
  1. Joshi HB, Stainthorpe A, Keeley FX Jr, Timoney AG. Characterization of urinary symptoms in patients with ureteral stents. Urology. 2002;59(4):511-6.
  2. oshi HB, stainethorpe A, MacDagh RP, Keeley FX Jr, Timoney AG, Barry MJ. Indwelling ureteral stents: evaluation of symptoms, quality of life and utility. J Urol 2003; 169:1065-9.
  3. Al-Kandari AM, et al. Effects of proximal and distal ends of double-J stent position on postprocedural symptoms and quality of life: a randomized clinical trial. J Endourol.2007;21 (7):698-702
Disclosures
Funding Faculty of Medicine Ramathibodi Hospital, Mahidol university Clinical Trial Yes Registration Number Thai Clinical Trials Registration ID TCTR20210420005 RCT Yes Subjects Human Ethics Committee Human Research Wthics Committee, Faculty of Medicine Ramathibodi Hospital, Mahidol university Helsinki Yes Informed Consent Yes
Citation

Continence 7S1 (2023) 100751
DOI: 10.1016/j.cont.2023.100751

05/05/2024 06:11:10