EFFICACY AND SAFETY OF USING TAMSULOSIN THERAPY IN WOMEN WITH LOWER URINARY TRACT SYMPTOMS (NON-NEUROGENIC CAUSE)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20250714006

Enrollment

150

Registered

2025-07-14

Start date

2023-05-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lower Urinary Tract Symptoms (LUTS) in women, specifically those without urinary tractinfections (UTI). Urinary Tract Symptoms Lower Urinary Tract Symptoms Tamsulosin Adrenergic alpha-1Receptor Antagonists Bladder Neck Urinary Flow Rate Urinary Retention Quality of Life Randomized Controlled Trials Female Urinary Incontinence

Interventions

administration of Tamsulosin 0.4 mg once daily at bedtime (HS),administration of Diclofenac Sodium 75 mg as needed (SOS).

Active Comparator Drug,Active Comparator Drug

Eligibility

Sex/Gender

Female

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1 Female patients aged 18-80 years. 2 Presence of Lower Urinary Tract Symptoms (LUTS) without urinarytract infections (UTI). 3 Normal urine study analysis (Urine R/M and C/S). 4 Minimum InternationalProstate Symptom Score (IPSS) of 8 or above.

Exclusion criteria

Exclusion criteria: 1 Patients with confirmed urinary tract infections based on Urine RM and CS. 2 Discontinuation ofmedical treatment by the patient. 3 Patients with mental disorders or illnesses unable to understand orcomply with the study protocol. 4 Known drug allergy or contraindications to Tamsulosin. 5 Pregnant orlactating women. 6 Conditions like stress urinary incontinence, post-radiation pelvic treatment, bladdercancer, vault prolapse. 7 Patients with urethral stricture. 8 Previous allergy to alpha-adrenoreceptorantagonists or sulpha drugs. 9 Hepatic or renal insufficiency.

Design outcomes

Primary

Measure	Time frame
Change in Peak Uroflow Rate (Qmax). Baseline, 2nd visit (week 2), 3rd visit (week 4), 4th visit (week 6), follow-up visit (week 8). ml/min	—

Secondary

Measure	Time frame
Improvement in urine flow (Qmax increase by 2.5 mL/s). Baseline, 2nd visit (week 2), 3rd visit (week 4), 4th visit (week 6), follow-up visit (week 8). Uroflowmetry (measuring the peak flow rate during voiding).,Change in International Prostate Symptom Score (IPSS) by 10% or 2-3 points. Baseline, 2nd visit (week 2), 3rd visit (week 4), 4th visit (week 6), follow-up visit (week 8). IPSS questionnaire.,Improvement in Quality of Life (QOL). Baseline, 2nd visit (week 2), 3rd visit (week 4), 4th visit (week 6), follow-up visit (week 8). Quality of life questionnaire.,Decrease in Post-Void Residual (PVR) volume. Baseline, 2nd visit (week 2), 3rd visit (week 4), 4th visit (week 6), follow-up visit (week 8). Bladder scan or ultrasound to measure post-void residual urine.	—

Measure

Time frame

Improvement in urine flow (Qmax increase by 2.5 mL/s). Baseline, 2nd visit (week 2), 3rd visit (week 4), 4th visit (week 6), follow-up visit (week 8). Uroflowmetry (measuring the peak flow rate during voiding).,Change in International Prostate Symptom Score (IPSS) by 10% or 2-3 points. Baseline, 2nd visit (week 2), 3rd visit (week 4), 4th visit (week 6), follow-up visit (week 8). IPSS questionnaire.,Improvement in Quality of Life (QOL). Baseline, 2nd visit (week 2), 3rd visit (week 4), 4th visit (week 6), follow-up visit (week 8). Quality of life questionnaire.,Decrease in Post-Void Residual (PVR) volume. Baseline, 2nd visit (week 2), 3rd visit (week 4), 4th visit (week 6), follow-up visit (week 8). Bladder scan or ultrasound to measure post-void residual urine.

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Countries

India

Contacts

Public ContactHimanshu Agrawal

UCMS and GTB Hospital, Delhi

himagr1987@gmail.com09999472790

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026