Female lower urinary tract symptoms (LUTS) Lower Urinary Tract Symptoms Urinary Incontinence Nocturia Urinary Frequency Urinary Urgency Urinary Retention Voiding Dysfunction
Conditions
Interventions
Baclofen tablet
1 tablet
per oral
once daily before bedtime
duration 4 weeks ,Tamsulosin tablet
0.4 mg
1 tab
per oral
once daily before bedtime
duration 4 weeks
Experimental Drug,Active Comparator Drug
Baclofen group,Alpha adrenergic antagonist group
Sponsors
Research Department Faculty of Medicine Siriraj Hospital Mahidol University
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Female 2. Age 18 years or older 3. Diagnosed with lower urinary tract symptoms (LUTS) according to ICS 2002 (The standardisation of terminology in lower urinary tract function). Symptoms can be during the storage phase, including urinary frequency, urgency, nocturia, and urinary incontinence, or during the voiding phase, including hesitancy, difficulty in emptying, poor stream, intermittency, straining to void, spraying of the urinary stream, and the sense of incomplete bladder emptying. The initial diagnosis must have been made at Siriraj Hospital, with symptoms persisting for more than 3 months.
Exclusion criteria
Exclusion criteria: 1. Patients with urinary retention. 2. Patients with pelvic organ prolapse, diagnosed by the presence of vaginal bulging or identified as stage 2 or higher pelvic organ prolapse upon examination. 3. Patients with a history of neurological diseases or conditions affecting lower urinary tract function, such as stroke or spinal diseases, within the past year. 4. Patients with a detected urethral tumor or cyst from a vaginal examination. 5. Patients with a history of pelvic radiation. 6. Patients with a history of anti-incontinence surgery or pelvic organ prolapse repair surgery. 7. Patients who have undergone urethral dilation, urethral surgery, or bladder augmentation surgery (augmentation cystoplasty). 8. Patients currently taking medications for bladder disorders, including antimuscarinics, beta3-adrenergic agonists, or bethanechol. 9. Elderly patients who are classified as frail, assessed by an ECOG performance status of more than or equal 2. 10. Patients who are pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in lower urinary tract symptoms (LUTS) 4 weeks after medication ICIQ-FLUTS 03/06 Questionnaire | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy of Baclofen in reducing lower urinary tract symptoms 4 weeks after medication ICIQ-FLUTS 03/06 Questionnaire | — |
Countries
Thailand
Contacts
Public ContactPatkawat Ramart
Siriraj Hospital, Faculty of Medicine, Mahidol University
Outcome results
None listed