Duloxetine for Mild to Moderate Postprostatectomy Incontinence: Preliminary Results of a Randomised, Placebo-Controlled Trial
Abstract
Background
Duloxetine is effective in the management of stress urinary incontinence (SUI) in women but has been poorly evaluated in the treatment of SUI following radical prostatectomy (RP).
Objective
To establish the superiority of duloxetine over placebo in SUI after RP.
Design, setting, and participants
We conducted a prospective, randomised, placebo-controlled, double-blind, monocentric superiority trial. After a placebo run-in period of 2 wk, patients with SUI after RP were randomised to receive either 80 mg of duloxetine daily or matching placebo for 3 mo.
Measurements
The primary outcome measure was the relative variation in incontinence episodes frequency (IEF) at the end of study compared to baseline. Secondary outcomes included quality of life (QoL) measures (Incontinence Impact Questionnaire Short Form [IIQ-SF], Urogenital Distress Inventory Short Form [UDI-SF], Incontinence Quality of Life [I-QoL]), symptom scores (Urinary Symptom Profile [USP] questionnaire, International Consultation on Incontinence/World Health Organisation Short Form questionnaire [ICIQ-SF], the Beck Depression Inventory [BDI-II] questionnaire), 1-h pad test, and assessment of adverse events.
Results and limitations
Thirty-one patients were randomised to either the treatment (n = 16) or control group (n = 15). Reduction in IEF was significant with duloxetine compared to placebo (mean ± standard deviation [SD] variation: −52.2% ± 38.6 [range: −100 to +46] vs +19.0% ± 43.5 [range: −53 to +104]; mean difference: 71.2%; 95% confidence interval [CI] for the difference: 41.0–101.4; p <>p = 0.006, p = 0.02, p = 0.0004, and p = 0.003, respectively). Both treatments were well tolerated throughout the study period.
Conclusions
Duloxetine is effective in the treatment of incontinence symptoms and improves QoL in patients with SUI after RP.
Keywords: Duloxetine, Urinary incontinence, Stress, Prostatectomy, Randomised controlled trial.
Abstrak
Latar belakang
Duloxetine efektif dalam pengelolaan stres inkontinensia urin (SUI) pada wanita tetapi telah buruk dievaluasi dalam pengobatan SUI berikut prostatektomi radikal (RP).
Tujuan
Untuk membangun keunggulan duloxetine atas plasebo pada SUI setelah RP.
Desain, pengaturan, dan peserta
Kami melakukan, prospektif acak, plasebo-terkontrol, buta ganda, sidang keunggulan monocentric. Setelah plasebo lari-dalam jangka waktu 2 minggu, pasien dengan SUI setelah RP secara acak untuk menerima 80 mg plasebo harian atau pencocokan duloxetine selama 3 mo.
Pengukuran
Ukuran hasil primer adalah variasi relatif pada frekuensi episode inkontinensia (IEF) pada akhir penelitian dibandingkan dengan baseline. Hasil sekunder termasuk kualitas hidup (kualitas hidup) mengukur (Inkontinensia Dampak Formulir Kuesioner Pendek [IIQ-SF], urogenital Distress Inventory Formulir Pendek [UDI-SF], Inkontinensia Kualitas Hidup [I-kualitas hidup]), skor gejala (urin Gejala Profil [USP] kuesioner, Internasional Konsultasi Inkontinensia Kesehatan / kuesioner Dunia Organisasi Short Form [ICIQ-SF], Beck Depression Inventory [BDI-II] kuesioner), uji pad 1-jam, dan penilaian efek samping.
Hasil dan keterbatasan
Tiga puluh satu pasien diacak untuk baik pengobatan (n = 16) atau kelompok kontrol (n = 15). Pengurangan IEF adalah signifikan dengan duloxetine dibandingkan dengan plasebo (rata-rata ± standar deviasi [SD] variasi: -52,2% ± 38,6 [range: -100 sampai 46] vs 19,0% ± 43,5 [jangkauan: -53 ke 104]; berarti perbedaan: 71,2%, 95% confidence interval [CI] untuk perbedaan tersebut: 41,0-101,4; p <0,0001).>IIQ-SF total skor, skor total UDI-SF, SUI subscore dari kuesioner USP, dan pertanyaan 3 dari kuesioner ICIQ-SF menunjukkan perbaikan pada kelompok duloxetine (p = 0,006, p = 0,02, p = 0,0004, dan p = 0,003, masing-masing). Kedua perlakuan ditoleransi dengan baik selama periode penelitian.
Kesimpulan
Duloxetine efektif dalam pengobatan gejala inkontinensia dan meningkatkan kualitas hidup pada pasien dengan SUI setelah RP.
Ambil pesan Depan
Duloxetine pada dosis harian 80 mg memperbaiki gejala dibandingkan dengan plasebo dalam pengelolaan stres inkontinensia urin setelah prostatektomi radikal.
Kata kunci: Duloxetine, inkontinensia urin, Stress, prostatectomy, acak controlled trial.
Pasal Outline
