Lower Urinary Tract Symptoms Clinical Trial
Official title:
Quantitative Comparison of Results Obtained by Self-administered IPSS, Sanitary Staff-supervised IPSS and Directed Medical History and Its Correlation With Clinical Parameters in the Assessment of Lower Urinary Tract Symptoms in Males
Descriptive prospective study carried out to compare the results obtained by self-administered IPSS (International Prostate Symptom Score), Sanitary staff-supervised IPSS and directed medical interview and its correlation with clinical parameters in the assessment of lower urinary tract symptoms in males.
The IPSS is a validated questionnaire (also in spanish language) widely used to evaluate
lower urinary tract symptoms (LUTS) in males. It contains 7 multiple-choice questions related
to urinary symptoms with a Likert response scale and 1 question assessing quality of life.
This test has been approved for self-administration and its purpose is quantifying and
monitoring symptoms severity.
The aim of this study is to compare the scores achieved in a self-administered IPSS
questionnaire with those obtained when the questionnaire is answered with the help and
supervision of a sanitary staff. These results will also be contrasted with the scores
retrieved in a standard directed medical interview and correlated with objective functional
parameters of lower urinary tract symptoms.
A descriptive prospective study will be carried out analysing lower urinary tract symptoms
from patients over 50 years old.
All patients will be provided with a IPSS to be fulfilled at home and after a short period of
time without any change in his LUTS treatment, the patient will repeat the questionnaire in
the hospital under the supervision of a sanitary staff.
A standard structured medical interview focusing in LUTS will be performed to every patient.
In order to compare the results achieved with both IPSS with those obtained during the
interview a Likert score was assigned to each question.
At the same time, objective lower urinary tract symptoms data will be collected and compared
to the results obtained previously with both the questionnaires and the medical interview.
Uroflowmetry and post physiological void residual volume measurement with ultrasonography
will be performed as evaluation of voiding symptoms. On the other hand, filling symptoms will
be evaluated with a validated 3-day voiding diary to be accomplished previously to the
medical visit.
Data to be collected includes Uroflowmetry parameters Qmax, Qm, curve shape type and time to
Qmax, ultrasonographic PVR (post-void residual) measurement and daytime and nightime number
of voids, medium volume of void, number of urgency and urge incontinence episodes and maximal
vesical functional volume wich will be extracted from the 3-day voiding diary.
A statistical analysis will be performed to compare the scores obtained through the
questionnaires and the medical interview and the correlation of each of them with the
objective clinical parameters obtained.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04856748 -
Nomogram to Diagnose Prostatic Inflammation (PIN) in Men With Lower Urinary Tract Symptoms
|
||
| Completed |
NCT03623880 -
Enhancing Behavioral Treatment for Women With Pelvic Floor Disorders
|
N/A | |
| Enrolling by invitation |
NCT06317116 -
Examining the Relationship Between Core Muscles and Bladder Issues in Children
|
||
| Completed |
NCT03625843 -
Mindfulness Exercises to Reduce Anxiety and Pain During Urodynamic Testing
|
N/A | |
| Recruiting |
NCT05814614 -
Bladder Complaints in Parkinson's Disease Effectiveness of Pelvic Floor Muscle Exercises and Electrical Stimulation
|
N/A | |
| Recruiting |
NCT04288427 -
5-Alpha Reductase 2 as a Marker of Resistance to 5ARI Therapy
|
N/A | |
| Not yet recruiting |
NCT06452927 -
EEP in Patients With Urodynamically Proven DU/DA
|
N/A | |
| Completed |
NCT03339609 -
Uroflow Measurement With Electromyography (EMG) to Identify Lower Urinary Tract Symptoms (LUTS): Conducted on Healthy Children
|
N/A | |
| Completed |
NCT02330107 -
Auriculotherapy on Lower Urinary Tract Symptoms in Elderly Men
|
N/A | |
| Terminated |
NCT02003742 -
Efficacy and Safety of a Single TRUS-guided Intraprostatic Injection of NX-1207 in Patients With LUTS Due to BPH
|
Phase 3 | |
| Terminated |
NCT01003249 -
Dysfunctional Voiding and Lower Urinary Tract Symptoms With Baclofen
|
Phase 4 | |
| Completed |
NCT01078545 -
Lucrin® Depot Efficacy and Safety Monitoring Study in Patients With Advanced Prostate Cancer and Lower Urinary Tract Symptoms (LUTS)
|
N/A | |
| Completed |
NCT02074644 -
Clinical Trial of Prostatic Arterial Embolization Versus a Sham Procedure to Treat Benign Prostatic Hyperplasia
|
N/A | |
| Recruiting |
NCT03802851 -
HoLEP Prior to Radiation Therapy for Patients With LUTS/Retention and Concurrent Prostate Cancer
|
N/A | |
| Active, not recruiting |
NCT05415748 -
Deprescribing Tamsulosin in Older Men
|
Phase 4 | |
| Recruiting |
NCT05702294 -
Electronic Urinary Flowmeter to Improve Accuracy of Bladder Diaries .
|
N/A | |
| Enrolling by invitation |
NCT05537272 -
The Efficacy of Tamsulosin and Tadalafil Compared to Placebo in the Treatment and Prevention of Urinary Disorders After Transperineal Prostate Biopsy
|
Phase 4 | |
| Recruiting |
NCT05826691 -
Benign Prostate Surgery and QOL and Sexual Function
|
||
| Completed |
NCT04104100 -
Prevalence and Risk Factor of NP in Women With LUTS
|
||
| Completed |
NCT04190641 -
Single-use Cystoscope System for Direct Visualization of the Urethra and Bladder
|
N/A |