Adding Desmopressin to Tamsulosin for Treatment of BPH

July 11, 2023 updated by: Mansoura University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Investigators will give a group of patients tamsulosin and desmopressin and the other group will take tamsulosin and placepo and compare the outcome regarding symptoms of being prostatic hyperplasia especially nocturia and the effect on nocturnal polyurea in patients

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Outside U.S./Canada
      • Mansoura, Outside U.S./Canada, Egypt, 35516
        • Recruiting
        • Urology and nephrology center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Desmopressin arm
This arm will receive tamsulosin and desmopressin
Drug: Desmopressin Acetate
This arm will receive tamsulosin and desmopressin acetate daily a
Placebo Comparator: Placebo arm
This arm will receive tamsulosin and placepo
Drug: Placebo
This arm will receive tamsulosin and placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of symptoms and nocturia disappears or improve
Time Frame: Follow up for 6 months
Investigators will compare symptoms in the pretreatment period and follow up symptoms following treatment and record the outcome
Follow up for 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 20, 2023

Primary Completion (Estimated)

January 10, 2024

Study Completion (Estimated)

February 10, 2024

Study Registration Dates

First Submitted

May 31, 2023

First Submitted That Met QC Criteria

July 11, 2023

First Posted (Actual)

July 14, 2023

Study Record Updates

Last Update Posted (Actual)

July 14, 2023

Last Update Submitted That Met QC Criteria

July 11, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS.22.12.2245

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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