Therapy of the Overactive Bladder Syndrome

NCT01314781 | Completed Phase 4 DMC

• 1 other identifier: SOL-OAB-01-08
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the present study is to investigate in patients with overactive bladder syndrome (OABS) whether a combination treatment of solifenacin with pelvic floor muscle training and whole body vibration training achieves a better treatment outcome than a treatment with solifenacin alone.

Conditions

Overactive Bladder

Keywords

Overactive Bladder; urinary frequency

Outcome Measures

Primary Outcomes (1)

• Change of patient perception of bladder condition (PPBC)

  The primary efficacy parameter is the change from baseline in mean score of patient perception of bladder condition (PPBC). Between-treatment differences in changes from baseline to endpoint will formally be tested using an analysis of variance (ANOVA). For the primary efficacy parameter, statistically significant superiority of solifenacin combined with pelvic floor muscle training (PFMT) and whole body vibration training (WBVT) to solifenacin alone must be obtained.

  baseline and 16 weeks

Secondary Outcomes (5)

• Change in micturitions/24h based on a 3-day micturition diary

  baseline and 16 weeks

• Change of urgency episodes (grade ≥3) /24h

  baseline and 16 weeks

• Change in volume voided per micturition

  baseline and 16 weeks

• Change in number of incontinence and urge incontinence episodes/24h

  baseline and 16 weeks

• Change in number of pads used/24h

  baseline and 16 weeks

Study Arms (2)

solifenacin 5mg, PFMT and WBVT

EXPERIMENTAL

Patients randomized to group A will receive solifenacin 5mg tablet once daily and a training programme for PFMT and WBVT once a week.

Drug: solifenacin; Procedure: PFMT and WBVT

solifenacin 5mg

ACTIVE COMPARATOR

Subjects randomised to group B will receive solifenacin 5mg tablet once daily.

Drug: solifenacin

Interventions

solifenacin DRUG

solifenacin 5mg tablet once daily

Also known as: brand name: vesicare

solifenacin 5mg; solifenacin 5mg, PFMT and WBVT

PFMT and WBVT PROCEDURE

pelvic floor muscle and whole body vibration training once a week

Also known as: Pelvic Floor Muscle Training, Whole Body Vibration Training, Galileo

solifenacin 5mg, PFMT and WBVT

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients with symptoms of overactive bladder (urinary frequency and urgency with or without incontinence) for ≥ 3 months
• Age ≥ 18 years old
• Urinary frequency ≥ 8 micturitions on average per 24 hours during the 3-day micturition diary period
• At least 3 episodes of urgency with or without incontinence (≥ 3) during the 3-day micturition diary period
• Patient provides written informed consent
• Patient is willing to complete the micturition diary

You may not qualify if:

• Clinically significant bladder outflow obstruction at risk of urinary retention (at the discretion of the investigator)
• Significant post void residual volume (\> 200ml)
• Uncontrolled narrow angle glaucoma, urinary or gastric retention, severe ulcerative colitis, toxic megacolon, myasthenia gravis or any other medical condition which in the opinion of the investigator makes the use of anticholinergics contraindicated
• Neurological cause of abnormal detrusor activity
• Any clinically significant condition, which in the opinion of the investigator makes the subject unsuitable for the study
• Current non-drug treatment including pelvic floor muscle and whole body vibration training
• Known contraindications for whole body vibration training (cardiovascular, neurological or orthopaedic diseases, diabetes, tumor, pacemaker)
• Pregnant women or women who intend to become pregnant during the study
• Known or suspected hypersensitivity to solifenacin or lactose
• Concomitant use of a strong cytochrome P450 3A4 inhibitor (e.g. ketoconazole)

Sponsors & Collaborators

• Cantonal Hospital, Frauenfeld: lead
• Astellas Pharma Inc: collaborator

Study Sites (1)

Blasenzentrum, Cantonal Hospital

Frauenfeld, Thurgau, 8501, Switzerland

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Solifenacin Succinate

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Volker VV Viereck, physican

  Cantonal Hospital, Frauenfeld

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: January 21, 2011
• First Posted: March 15, 2011
• Study Start: January 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: March 1, 2015
• Last Updated: May 20, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)