Overactive Bladder Syndrome
Conditions
Interventions
Trade Name: Vesicare
Pharmaceutical Form: Tablet
INN or Proposed INN: SOLIFENACIN
CAS Number: 242478-38-2
Current Sponsor code: FFIS/2017/01/SLT
Other descriptive name: SOLIFENACIN SUCCINATE
Concentra
Sponsors
Fundación para la Formación e Investigación Sanitarias de la Región de Murcia
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Women> 18 years, diagnosed with SVHI for at least 6 months of evolution and who have taken Beta 3 agonists. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 46 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 70
Exclusion criteria
Exclusion criteria: 1) Patients who can contribute biased information: have previously consumed and abandoned anticholinergic drugs due to lack of efficacy or side effects; Suffering from overactive bladder of neurogenic origin (multiple sclerosis, Parkinson's, spinal cord injury); Present cystocele or any prolapse of pelvic organs grade> 2 according to POP-Q classification (39). 2) Patients who may become worse with the interventions envisaged in the study: being a pacemaker-ICD; Who can not take anticholinergics (for hypersensitivity, megacolon, myasthenia gravis, narrow-angle glaucoma); With cutaneous alterations in lower extremities that prevent the placement of electrodes on the surface; Pregnant women or who may be pregnant during the duration of the clinical trial ..
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: During three days the three following months;Main Objective: - To determine if the T-PTNS is not inferior in the short term (3 months) to one of the usual pharmacological treatments (Solifenacin) in the treatment of SVHI and with respect to the percentage of patients that improve 50% any of the 3 signs (Urinary frequency, diurnal / nocturnal frequency, urgency and urinary incontinence). - To determine prognostic factors associated with insufficient improvement (less than 50% in the 3 main signs of SVHI (urinary frequency, urgency and urinary incontinence frequency) after treatment with T-PTNS and Solifenacin.;Secondary Objective: - To determine the short-term (3-month) effectiveness of T-PTNS versus Solifenacin in patients with SVHI with respect to: quality of life associated with overactive bladder and incontinence, change in urodynamic parameters and perception Subjective change. - To determine the safety of the application of T-PTNS against Solifenacin in patients with SVHI with respect to the number of adverse effects produced. - To determine prognostic factors associated with insufficient subjective improvement (less moderate change) after treatment of SVHI with T-PTNS and Solifenacin.;Primary end point(s): Occurrence of a relevant reduction (equal or greater than 50%) in any of the 3 main signs of SVHI (urinary frequency, diurnal / nocturnal frequency, urgency and urinary incontinence). The three signs will be measured with a voiding diary of 3 days in the baseline study weeks and the completion of the first and third month. 3-day urination diaries are a reliable tool and have been shown to be sensitive to change. The 3-day voiding diary (DM3d) has been validated in Spain in the evaluation of STUI in women, and is available through the website of the Spanish Association of Urology | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Urodynamic changes occurring at 3 months in relation to the following parameters: (i) Mical volume at which the first uninhibited contraction originates, in case of detrusoric hyperactivity; (Ii) extent of uninhibited contractions; (Iii) Total bladder capacity (iv) Post-admixture; V) Flowmetry: Qmax, mean Q, time of urination. All these parameters will be measured with instruments calibrated and available in each center for urodynamic studies. 2. Perception of change in treatment over each of the 3 main signs of overactive bladder syndrome (frequency, nocturia, urinary incontinence), scored by the patient on a valid and reliable seven-point scale (markedly worse, moderately worse , Slightly worse, equal, slightly better, moderately better and markedly better). Change will be considered when the patient has moderately or markedly improved. Insufficient improvement in the rest of the answers. 3. Number of adverse effects related to the mouth per month and 3 months of follow-up. At each visit, a blind assessor will determine if there was any adverse effect during the previous month. The effects may be related to deterioration in dry mouth (or xerostomia), salivary flow and oral quality of life compared to basal. Xerostomia will be measured using a validated questionnaire (36) consisting of 7 items related to oral dryness and a last item where the patient scores overall their level of dryness, this questionnaire that allows us to measure the intensity of oral symptoms using Scales Analog Visuals (EVAs). The amount of saliva will be measured with the non-stimulated salivary flow test. This test allows to know changes in the secretion and if it performs a normal or low salivary secretion. Oral quality of life will be measured using the Oral Health Impact Profile (OHIP-14) test in its Spanish-validated version. It is presented in the form of questions about everyday situations that the patient must respond to as often as they happen. 4. Number | — |
Countries
Spain
Contacts
Public ContactUICEC
Fundación para la Formación e Investigación Sanitarias de la Región de Murcia
Outcome results
None listed