Clinical trial

Outcome of Adding Desmopressin to Tamsulosin for Treatment of Nocturnal Polyurea in Patients With Benign Prostatic Obstruction

Name

MS.22.12.2245

Description

In this study investigators will add desmopressin for treatment of patients with benign prostatic hyperplasia and nocturnal polyurea

Trial arms

Trial start

2023-07-20

Estimated PCD

2024-01-10

Trial end

2024-02-10

Status

Recruiting

Phase

Early phase I

Treatment

Desmopressin Acetate

This arm will receive tamsulosin and desmopressin acetate daily a

Arms:

Desmopressin arm

Placebo

This arm will receive tamsulosin and placebo

Arms:

Placebo arm

Size

160

Primary endpoint

Change of symptoms and nocturia disappears or improve

Follow up for 6 months

Eligibility criteria

Inclusion Criteria: Men with BPH Age more than 50years Patients with nocturia (2voids per night or More) Patients with nocturnal polyurea (urine volume More than 33%of urine allover the day) IPSS more than 12 Obstructed flow curve Post voiding residual less than 150 Exclusion Criteria: * men with BPH with : Acute urine retention Neurogenic bladder dysfunction Cardiovascular disease Hyponatremia Urethral stricture Bladder calculi Prostate cancer

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 160, 'type': 'ESTIMATED'}}

Updated at

2023-07-14

1 organization

1 product

1 drug

1 indication

Organization

Product

Indication

Drug