NCT05945420

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2023

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 14, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

July 20, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2024

Completed
Last Updated

July 14, 2023

Status Verified

July 1, 2023

Enrollment Period

6 months

First QC Date

May 31, 2023

Last Update Submit

July 11, 2023

Conditions

Nocturnal Polyurea in Patients With BPH

Outcome Measures

Primary Outcomes (1)

  • Change of symptoms and nocturia disappears or improve

    Investigators will compare symptoms in the pretreatment period and follow up symptoms following treatment and record the outcome

    Follow up for 6 months

Study Arms (2)

Desmopressin arm

ACTIVE COMPARATOR

This arm will receive tamsulosin and desmopressin

Drug: Desmopressin Acetate

Placebo arm

PLACEBO COMPARATOR

This arm will receive tamsulosin and placepo

Drug: Placebo

Interventions

Desmopressin AcetateDRUG

This arm will receive tamsulosin and desmopressin acetate daily a

Desmopressin arm
PlaceboDRUG

This arm will receive tamsulosin and placebo

Placebo arm

Eligibility Criteria

Age50 Years - 80 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • men with BPH with : Acute urine retention Neurogenic bladder dysfunction Cardiovascular disease Hyponatremia Urethral stricture Bladder calculi Prostate cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology and nephrology center

Al Mansurah, Outside U.S./Canada, 35516, Egypt

RECRUITING

MeSH Terms

Interventions

Deamino Arginine Vasopressin

Intervention Hierarchy (Ancestors)

Arginine VasopressinVasopressinsPituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Central Study Contacts

Ahmed Azmy, Resident

CONTACT

+20 01010623936dr.a.azmy93@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2023

First Posted

July 14, 2023

Study Start

July 20, 2023

Primary Completion

January 10, 2024

Study Completion

February 10, 2024

Last Updated

July 14, 2023

Record last verified: 2023-07

Locations

EG(1)