The Efficacy of Nano-water in Combination With Tamsulosin- Dutasteride for Lower Urinary Tract Symptoms

NCT06677177 | Completed DMC

• 1 other identifier: 574
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if nano-water combined with tamsulosin and dutasteride can relieve the symptoms of lower urinary tract symptoms in adults with benign prostatic hyperplasia . The main questions it aims to answer are: Does nano-water improve the results of treating patients with lower urinary tract symptoms? What is the difference between the medications alone and the medications with nano-water? Researchers will compare nano-water to a placebo (an ordinary bottled drinking water) to see if nano-water works to treat lower urinary tract symptoms . Participants will: Take (nano-water combined with Tamsulosin and Dutasteride) or a placebo an (ordinary bottled drinking water) combined with Tamsulosin and Dutasteride every day for 3 months Visit the clinic once every 4 weeks for checkups Keep a diary of their symptoms and the frequency of these symptoms

Conditions

Lower Urinary Tract Symptoms

Keywords

Lower urinary tract symptoms; benign Prostate Hyperplasia; Tamsulosin; Dutasteride; Nano-water; International Prostate Symptom Score IPSS

Outcome Measures

Primary Outcomes (3)

• International Prostate Symptoms Score IPSS

  International Prostate Symptoms Score IPSS include 7 questions , to which each question is given a number of 1-5 , these questions include: Frequency, Urgency, Hesitancy, Nocturia, Incomplete emptying, Weak stream, Straining.

  From enrollment to the end of treatment at 3 months

• Qmax

  Qmax is the maximum flow rate of urine measure by a Flowmetry device and expressed in ml/second

  From enrollment to the end of treatment at 3 months

• Residual Urine

  Residual Urine is the post-voiding residual volume of urine remaining in the urinary bladder after voiding, measure by an ultrasound machine and expressed in ml.

  From enrollment to the end of treatment at 3 months

Study Arms (2)

Patients with LUTS due to BPH/ nano-water

EXPERIMENTAL

Patients with Lower Urinary Tract Symptoms due to Benign Prostatic Hyperplasia receiving nano-water combined with tamsulosin and Dutasteride

Dietary Supplement: Nano-water, Tamsulosin Dutasteride

Patients with LUTS due to BPH/regular water

ACTIVE COMPARATOR

Patients with Lower Urinary Tract Symptoms due to Benign Prostatic Hyperplasia receiving regular water combined with tamsulosin and Dutasteride

Drug: Regular water, tamsulosin, Dutasteride

Interventions

Nano-water, Tamsulosin Dutasteride DIETARY_SUPPLEMENT

Nano-water, given in a dose of 20 ml/kg daily for a period of 3 months Tamsulosin capsule in a dose of 0.4mg daily for a period of 3 months Dutasteride tablet in a dose of 0.5mg daily for a period of 3 months

Also known as: Tamsulosin, Dutasteride

Patients with LUTS due to BPH/ nano-water

Regular water, tamsulosin, Dutasteride DRUG

Regular water, given in a dose of 20 ml/kg daily for a period of 3 months Tamsulosin capsule in a dose of 0.4mg daily for a period of 3 months Dutasteride tablet in a dose of 0.5mg daily for a period of 3 months

Also known as: Tamsulosin, Dutasteride

Patients with LUTS due to BPH/regular water

Eligibility Criteria

• Age: 50 Years+
• Gender Eligibility Details: male with benign prostatic hyperplasia
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• prostate size \>30 cc and \< 80 cc
• IPSS \>13

You may not qualify if:

• High serum PSA
• Urinary tract infections

Sponsors & Collaborators

• ALI KAMAL M. SAMI: lead
• University of Sulaimani: collaborator

Study Sites (1)

College of Medicine

Sulaymaniyah, Kurdistan Region, 46001, Iraq

Location

MeSH Terms

Conditions

Lower Urinary Tract Symptoms; Prostatic Hyperplasia

Interventions

Tamsulosin; Dutasteride

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Azasteroids; Steroids, Heterocyclic; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Ali K M. Sami

  College of Medicine, University of Sulaimani

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer , Urology , Department of Surgery, College of Medicine, Medical Doctor

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 6, 2024
• Study Start: February 16, 2016
• Primary Completion: November 19, 2022
• Study Completion: November 19, 2022
• Last Updated: November 6, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)