Silodosin in Females with Voiding Dysfunction: Safety and Efficacy, A Pilot Study.

Alenezi A1, Salem S2, Taleb S3, Almazeedi A3, Alfahad M3, Alkabbani M4, Alyousef R5, Al-Terki A4, Al-Shaiji T3

Research Type

Clinical

Abstract Category

Female Lower Urinary Tract Symptoms (LUTS) / Voiding Dysfunction

Abstract 382
Open Discussion ePosters
Scientific Open Discussion Session 5
Wednesday 27th September 2023
13:25 - 13:30 (ePoster Station 3)
Exhibit Hall
Female Quality of Life (QoL) Retrospective Study Voiding Dysfunction
1. Kuwait Urology Board, KIMS, Kuwait, 2. Menoufia University, Egypt, 3. Jaber Al-Ahmad Hospital, kuwait, 4. Amiri Hospital, Kuwait, 5. Al-Amiri Hospital, Kuwait
Presenter
Links

Poster

Abstract

Hypothesis / aims of study
Lower urinary tract symptoms (LUTS) have been increasingly reported among females attending urology outpatient department. In addition, they adversely affect the quality of life in multiple aspects including quality of sleep and job performance. The prevalence of LUTS in females is reported to be around 20% [1]. Silodosin has long been studied for safety and efficacy in male patients with benign prostatic hyperplasia [2].  Therefore, it might have a role in managing failure to empty symptoms in females. To our knowledge, there are no studies on silodosin in the treatment of female lower urinary tract symptoms. This study was conducted to determine the safety of silodosin in the treatment of female lower urinary tract symptoms, as well as efficacy.
Study design, materials and methods
This study is a retrospective analysis of 170 patients presenting with Lower urinary tract symptoms from the age of 18 to 75. Patients were evaluated with an IPSS score and uroflowmetry with post void residual. Only seventy patients agreed to participate in the study. Patients were managed with off label silodosin either alone or in combination with other medications. The patients were heterogenous in diagnosis ranging from female bladder outlet obstruction, true and pseudo DSD, overactive bladder associated with an element of decreased contractility, dysfunctional voiding or high post void residual. and under-active bladder diagnosed by urodynamics. Patients were then evaluated at one month post treatment for safety as primary endpoint and efficacy as secondary endpoint.
Results
Patients mean age was 43.5 ± 12.79 years. The study included a heterogenous group of patients with LUTS diagnosed by urodynamics with over-active bladder alone or in combination (61.79%), female bladder outlet obstruction (10%), true and pseudo DSD (5%), and dysfunctional voiding (18.37%). Patients mean IPSS score was 20.6 ± 7.13. 25% of the patients were started on silodosin in combination with solifenacin. 20% were on Silodosin alone, 11.76% were on Silodosin and mirabegron. 
 At 1 month follow up, 80% of the patients were compliant with silodosin. Fifty-nine patients (86.76%) were satisfied with the medication and did not report any side effects.  Only 5 patients (7.35%) reported dizziness and 3 patients (4.41%) developed Insomnia. Overall, 14 patients discontinued Silodosin, 4 of the patients stopped it due to the side effects mentioned (5.88%), and 10 patients (14.7%) stopped it due to ineffectiveness in improving their failure to empty symptoms.
As far as efficacy is concerned, fifty (73.5%) patients reported subjective improvement in their failure to empty symptoms. IPSS decreased by mean of 12.4 ± 7.4 and the difference was statistically significant with a P. value <0.001. However, due to the heterogeneity of the cohort, this improvement is most likely due to the combination of an anticholinergic or beta 3 agonist with Silodosin.
Interpretation of results
Our results demonstrate that silodosin is safe to use in females with failure to empty symptoms. 73.5% improvement in their symptoms in an indicator of silodosin safety. With reported side effects such as insomnia in 4.4% and dizziness in 7.35%, these results are comparable with the side effects reported in male patients receiving silodosin. Dizziness was reported in 13.3% of patients (N=93) receiving silodosin in a randomised controlled trial comparing tamsulosin, alfuzosin and silodosin [3].
Concluding message
Silodosin is a safe medication to use in females with LUTS, it helps with failure to void symptoms. Reported side effects were seen 11.76% of patients, mainly insomnia and dizziness and only 5.88% stopped the medication due to the side effects reported. Patients showed subjective improvement in both IPSS and quality of life. Further prospective studies are warranted to delineate the efficacy of silodosin.
References
  1. Moller LA, Lose G, Jorgensen T. The prevalence and bothersomeness of lower urinary tract symptoms in women 40-60 years of age. Acta Obstet Gynecol Scand. 2000;79:298-305.
  2. Yamanishi T, Mizuno T, Tatsumiya K, Watanabe M, Kamai T, Yoshida K.Urodynamic effects of silodosin, a new alpha 1A-adrenocept or selectiveantagonist, for the treatment of benign prostatic hyperplasia. Neurourol. Uro-dyn. 2010; 29: 558–62.
  3. Manohar CMS, Nagabhushana M, Karthikeyan VS, Sanjay RP, Kamath AJ, Keshavamurthy R. Safety and efficacy of tamsulosin, alfuzosin or silodosin as monotherapy for LUTS in BPH - a double-blind randomized trial. Cent European J Urol. 2017 Jun 30;70(2):148-153. doi: 10.5173/ceju.2017.924. Epub 2017 Jun 7. PMID: 28721281; PMCID: PMC5510335.
Disclosures
Funding None Clinical Trial No Subjects None
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