Adding Desmopressin to Tamsulosin for Treatment of BPH

NCT ID: NCT05945420

Last Updated: 2023-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-20

Study Completion Date

2024-02-10

Brief Summary

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

Detailed Description

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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

Conditions

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Nocturnal Polyurea in Patients With BPH

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Desmopressin arm

This arm will receive tamsulosin and desmopressin

Group Type ACTIVE_COMPARATOR

Desmopressin Acetate

Intervention Type DRUG

This arm will receive tamsulosin and desmopressin acetate daily a

Placebo arm

This arm will receive tamsulosin and placepo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

This arm will receive tamsulosin and placebo

Interventions

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Desmopressin Acetate

This arm will receive tamsulosin and desmopressin acetate daily a

Intervention Type DRUG

Placebo

This arm will receive tamsulosin and placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Urology and nephrology center

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

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ahmed Azmy, Resident

Role: CONTACT

+20 01010623936

Facility Contacts

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Ahmed M. Shoma, PhD

Role: primary

502202222

Other Identifiers

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MS.22.12.2245

Identifier Type: -

Identifier Source: org_study_id

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