Clinical trial NCT01799902: Treatment of Symptoms in Male Patients With Lower Urinary Tract Symptoms (LUTS) Predominant Storage Symptoms (Overactive Bladder Syndrome)
Official title: Belgian Observational Study to Evaluate Storage and Voiding Symptoms Improvement in Male Subjects With Lower Urinary Tract Predominant Storage Symptoms (Overactive Bladder Syndrome) Being Treated With Solifenacin in Monotherapy or Combination
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lower Urinary Tract Predominant Storage Symptoms
Keywords: Observational
Non-Interventional Prospective
Phase IV Treatment
Overactive Bladder Syndrome
Solifenacin
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Veeda Clinical Research
First posted: 2013-02-27
Enrollment: 86
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male patients in Belgium with lower urinary tract predominant storage symptoms (Overactive Bladder Syndrome) being treated with solifenacin in monotherapy or combination.

Brief summary: This study is a non interventional study where no investigational medicine is provided. Procedures and examination will follow the institution standard of care practice. The therapeutic approach will not be decided in advance by the protocol or influenced in any way by the protocol.

After standard evaluation the investigator will decide the treatment strategy and upon eligibility criteria met will propose subject to participate to the study. Informed consent will be collected for all subjects.

The study will consist of 3 possible observational visits; V1 (enrolment), V2 and V3 (follow up).

During all observational visits (V1, V2 and V3) the patient will complete the I-PSS (International Prostate Symptom Score) questionnaire including Quality Of Life (QOL) questionnaire and a Patient assessment of treatment benefit and satisfaction using a Visual Analogue Scale (VAS).

The patient will be asked to complete a voiding diary the first 3 days after Visit 1 (Baseline diary), 3 days before Visit 2 and again 3 days before Visit 3.

Prostate Specific Antigen (PSA) measurement- Uroflowmetry - Post Voiding Residual volume and Trans Rectal Ultra Sound data will be collected only if available.

During all observational visits (V1, V2 and V3) the investigator will complete the assessment of treatment benefit and satisfaction using a VAS.


Eligibility criteria: Inclusion Criteria:

The following subjects can be included in this study if they answer the following criteria:

* they have been prescribed solifenacin 5-10mg according to Summary of Product Characteristics (SmPC).
* Subjects with diagnosed Lower Urinary Tract Symptoms (LUTS) with substantial storage disorder defined as urgency, and/or frequency and/or Urge Urinary Incontinence (UUI) at the discretion of the investigator.
* IPSS storage sub-score \> 8
* Subject expected to require at least 3 months treatment with solifenacin.

Exclusion Criteria:

* Any reason which following current medical knowledge, physical condition of the patient and in the opinion of the investigator contraindicates administration of solifenacin to the subject, such as- signs and symptoms suggestive of urinary tract infection (confirmed by positive urine analysis).
* History of bladder obstruction not being adequately corrected.
* Anticipate or plan to participate in another study during study period of 12 weeks from study entry.

Primary outcomes:
measure: Change in I-PSS storage scores (frequency, urgency, nocturia)
timeFrame: Baseline, Week 6 and 12
Secondary outcomes:
measure: Change in Storage symptoms assessed in the patient bladder diary by Mean number of micturitions per 24 hours
timeFrame: Baseline, Week 6 and 12
measure: Change in Storage symptoms assessed in the patient bladder diary by Mean number of incontinence episodes per 24 hours
timeFrame: Baseline, Week 6 and 12
measure: Change in Storage symptoms assessed in the patient bladder diary by Mean number of urgency (grade 3 or 4, Patient Perception of Intensity of Urgency Scale (PPIUS)) episodes per 24 hours
timeFrame: Baseline, Week 6 and 12
measure: Change in Storage symptoms assessed in the patient bladder diary by Mean number of urge incontinence (grade 4, PPIUS) episodes per 24 hours
timeFrame: Baseline, Week 6 and 12
measure: Voiding scores (incomplete emptying, intermittency, weak stream and straining)
timeFrame: Week 1, 6 and 12
measure: Total and individual I-PSS item scores
timeFrame: Week 1, 6 and 12
measure: Quality Of Life assessed by the patient I-PSS questionnaire
timeFrame: Week 1, 6 and 12
measure: Treatment satisfaction and treatment benefit for investigator using a visual analogue scale (VAS)
timeFrame: Week 1, 6 and 12
measure: Treatment satisfaction and treatment benefit for patient using a visual analogue scale (VAS)
timeFrame: Week 1, 6 and 12
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: ASZ
city: Antwerpen
country: Belgium
facility: ZNA Stuyvenberg
city: Brussel
country: Belgium
facility: Erasme
city: Brussel
country: Belgium
facility: UZ Brussel
city: Brussel
country: Belgium
facility: Private practice
city: Deurne
country: Belgium
facility: AZ St. Monica
city: Edegem
country: Belgium
facility: UZ Antwerpen
city: Gent
country: Belgium
facility: Maria Middelares
city: Gent
country: Belgium
facility: Sint-Lucas
city: Gent
country: Belgium
facility: UZ Gent
city: Kortrijk
country: Belgium
facility: AZ Groeninge
city: Oostende
country: Belgium
facility: AZ Damiaan
city: Oudenaarde
country: Belgium
facility: AZ Oudenaarde
city: Roeselaere
country: Belgium
facility: H.Hart Roeselaere
city: Zottegem
country: Belgium
facility: AZ Sint Elisabeth
Study officials:
affiliation: Astellas Pharma Europe B.V.
name: Medical Director
role: STUDY_DIRECTOR
References: