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Completed

NCT Number: NCT01799902

Treatment of Symptoms in Male Patients With Lower Urinary Tract Symptoms (LUTS) Predominant Storage Symptoms (Overactive Bladder Syndrome)

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.

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Key information

Conditions

Lower Urinary Tract Predominant Storage Symptoms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

ASZ, Aalst, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

solifenacin

Drug

Oral

Other names: YM905, Vesicare®

Primary outcomes

  1. Change in I-PSS storage scores (frequency, urgency, nocturia)

    Time frame: Baseline, Week 6 and 12

    To evaluate the effect of solifenacin monotherapy or combination with an α receptor blocker on storage symptoms measured by the patient I-PSS (International Prostate Symptom Score questionnaire)

Secondary outcomes

  1. Change in Storage symptoms assessed in the patient bladder diary by Mean number of micturitions per 24 hours

    Time frame: Baseline, Week 6 and 12

  2. Change in Storage symptoms assessed in the patient bladder diary by Mean number of incontinence episodes per 24 hours

    Time frame: Baseline, Week 6 and 12

  3. 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

    Time frame: Baseline, Week 6 and 12

  4. Change in Storage symptoms assessed in the patient bladder diary by Mean number of urge incontinence (grade 4, PPIUS) episodes per 24 hours

    Time frame: Baseline, Week 6 and 12

  5. Voiding scores (incomplete emptying, intermittency, weak stream and straining)

    Time frame: Week 1, 6 and 12

  6. Total and individual I-PSS item scores

    Time frame: Week 1, 6 and 12

  7. Quality Of Life assessed by the patient I-PSS questionnaire

    Time frame: Week 1, 6 and 12

  8. Treatment satisfaction and treatment benefit for investigator using a visual analogue scale (VAS)

    Time frame: Week 1, 6 and 12

  9. Treatment satisfaction and treatment benefit for patient using a visual analogue scale (VAS)

    Time frame: Week 1, 6 and 12

Sponsors and collaborators

Lead sponsor

Astellas Pharma Europe B.V.

Industry

Collaborators

  • Veeda Clinical Research

Registry information

Official study 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

Acronym: VENICE

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Feb 27, 2013
Registry last updated
Dec 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.