Nocturnal Polyurea in Patients With BPHPhase 4NCT05945420
Adding Desmopressin to Tamsulosin for Treatment of BPH
A Phase 4 study testing Desmopressin Acetate in people with Nocturnal Polyurea in Patients With BPH, run by Mansoura University at 1 site in Egypt.
Trial summary
In this study investigators will add desmopressin for treatment of patients with benign prostatic hyperplasia and nocturnal polyurea Read more about this study
- Who is it for?
- Ages 50 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Nocturnal Polyurea in Patients With BPH
- What is being tested?
- Desmopressin Acetate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jul 2023to 10 Feb 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- men with BPH with : Acute urine retention Neurogenic bladder dysfunction Cardiovascular disease Hyponatremia Urethral stricture Bladder calculi Prostate cancer
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Urology and nephrology center
Al Mansurah, Outside U.S./Canada, 35516
Ahmed M. Shoma, PhD, 502202222, ahmed.shoma@hotmail.com
About this study
Official title: 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
Read the 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
- Conditions
- Nocturnal Polyurea in Patients With BPH
- Being tested
- Desmopressin Acetate, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Desmopressin AcetateDrug
This arm will receive tamsulosin and desmopressin acetate daily a
PlaceboDrug
This arm will receive tamsulosin and placebo
| Study group | Role | What they receive |
|---|---|---|
| Desmopressin arm | Active comparator | This arm will receive tamsulosin and desmopressin Receives: Drug: Desmopressin Acetate |
| Placebo arm | Placebo comparator | This arm will receive tamsulosin and placepo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Follow up for 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start20 Jul 2023 (estimated)
- Primary completion10 Jan 2024 (estimated)
- Study completion10 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nocturnal Polyurea in Patients With BPHStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05945420
- Sponsor's protocol ID
- MS.22.12.2245
- Status last verified
- Jul 2023
- First submitted
- 31 May 2023
- Last updated
- 14 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Adding Desmopressin to Tamsulosin for Treatment of Nocturnal Polyurea in Patients With Benign Prostatic Obstruction
- ClinicalTrials.gov ID
- NCT05945420
- Acronym / sponsor ID
- MS.22.12.2245
- Conditions
- Nocturnal Polyurea in Patients With BPH
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 20 Jul 2023 (estimated)
- Primary completion
- 10 Jan 2024 (estimated)
- Study completion
- 10 Feb 2024 (estimated)
- First posted
- 14 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study investigators will add desmopressin for treatment of patients with benign prostatic hyperplasia and nocturnal polyurea
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Desmopressin arm | Active comparator | Drug: Desmopressin AcetateThis arm will receive tamsulosin and desmopressin |
| Placebo arm | Placebo comparator | Drug: PlaceboThis arm will receive tamsulosin and placepo |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- men with BPH with : Acute urine retention Neurogenic bladder dysfunction Cardiovascular disease Hyponatremia Urethral stricture Bladder calculi Prostate cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Desmopressin AcetateThis arm will receive tamsulosin and desmopressin acetate daily a | Drug | Desmopressin arm |
| PlaceboThis arm will receive tamsulosin and placebo | Drug | Placebo arm |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Desmopressin Acetate in people with Nocturnal Polyurea in Patients With BPH, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Azmy, Resident (+20 01010623936, dr.a.azmy93@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of symptoms and nocturia disappears or improve (time frame: Follow up for 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2023; AzTrials last refreshed its copy on 8 Nov 2026.