- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07596537
The Effect of Detrusor Underactivity in Determining Outcomes After Transurethral Resection of the Prostate for Treatment of Benign Prostatic Hyperplasia
The aim of this clinical trial is to evaluate the effect of detrusor underactivity on the functional and symptomatic outcomes following transurethral resection of the prostate (TURP) in benign prostatic hyperplasia patients presenting with chronic urinary retention.
The main questions it aims to answer are:
Will they restore spontaneous voiding?
They will be divided into 2 comparative groups (each group 45 patients) based on detrusor contractility.
- Group (A) consists of patients with normal detrusor (bladder contractility index more than 100).
- Group (B) consists of patients with underactive detrusor (bladder contractility index less than 100).
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Samir Sherif Rizkallah, MBBCH
- Phone Number: +201226846005
- Email: 150278@med.asu.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age: more than 50-year-old
- Chronic urinary retention secondary to BPH
- Prostate size Above 30 and less than 100gm
Exclusion Criteria:
- Prostate size over 100 gm and less than 30 gm
- Prostatic carcinoma
- Urinary bladder carcinoma
- Acute urinary retention
- Urethral stricture.
- Previous bladder, urethral or prostate surgery.
- Acute urinary tract infection.
- Neurogenic bladder
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: consists of patients with underactive detrusor (bladder contractility index less than 100).
• Group (B) - Underactive Detrusor
|
Standard TURP
|
|
Active Comparator: consists of patients with normal detrusor (bladder contractility index more than 100).
• Group (A) - Normal detrusor
|
Standard TURP
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Restore spontaneous voiding
Time Frame: 3 months
|
All the included patients in this study are urethral catheter-dependant pre-operatively and have very bad voiding parameters.
we will assess how they will benefit after TURP by regaining spontaneous voiding without the need for urethral catheters any more.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Flow rate improvement
Time Frame: 3 months
|
uroflowmetry will be done to all patients 3 months post operative and results will be compared
|
3 months
|
|
Post voiding residual urine volume decrease
Time Frame: 3 months
|
Post voiding residual urine volume will be calculated using ultrasound and results will be compared
|
3 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Male Urogenital Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Urinary Bladder Diseases
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Urinary Bladder, Underactive
- Surgical Procedures, Operative
- Urologic Surgical Procedures
- Urogenital Surgical Procedures
- Urologic Surgical Procedures, Male
- Prostatectomy
- Transurethral Resection of Prostate
Other Study ID Numbers
- Detrusor Underactivity & TURP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Study Data/Documents
-
Clinical Study Report
Information identifier: 33645847
-
Clinical Study Report
Information identifier: 24184024
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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