In previous studies, in which the perception threshold and / or sensory evoked potentials at different points of the lower urinary tract were examined and measured by means of electrical stimulation, a clear increase in the volume of the bladder and thus the urine excretion under the stimulation could be observed. This observation is now to be investigated more closely in a separate study, in order to strengthen the observation with further measured data and to find possible physiological connections. A detectable influence of electrical stimulation in the lower urinary tract on renal urine production would have a significant relevance both therapeutically and for the neurophysiological understanding of interactions between the lower and upper urinary tracts.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Balgrist University Hospital
Zurich, Switzerland
Change in urine output (ml/s)
Time frame: 10 minutes
Systolic and diastolic blood pressure
Blood pressure is measured using Finometer® device (Finapres Medical Systems, the Netherlands). Unit: mmHg.
Time frame: Immediately before, during and immediately after the intervention
Heart rate
Finometer® device (Finapres Medical Systems, the Netherlands). Unit: beats per minute.
Time frame: Immediately before, during and immediately after the intervention
Sympathetic skin response
The sympathetic skin response is measured using Finometer® device (Finapres Medical Systems, the Netherlands). Unit: mVs.
Time frame: Immediately before, during and immediately after the intervention
Renal restistance index
The resistive index (RI) is measured using Doppler ultrasound
Time frame: Immediately before, during and immediately after the intervention
International Consultation on Incontinence Questionnaire-Female Lower Urinary Tract Symptoms (ICIQ-FLUTS)
The ICIQ-FLUTS ("International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms Module") questionnaire assesses female lower urinary tract symptoms and impact on quality of life. It consists of 12 items covering 3 domains, namely filling symptoms, voiding symptoms and incontinence symptoms. The filling symptoms subscale is the sum of is the sum of item 2 to 5, the voiding symptom subscale is the sum of item 6 to 8 and the incontinence symptoms subscale is the sum of item 9 to 13. The lowest possible score is 0 for all subscales, while the highest possible score is 16 for the filling symptoms subscale, 12 for the voiding symptoms subscale and 20 for the incontinence symptoms subscale. The higher the score, the more symptomatic.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Once at screening visit
International Consultation on Incontinence Questionnaire-Male Lower Urinary Tract Symptoms (ICIQ-MLUTS)
The ICIQ-MLUTS ("International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms Module") questionnaire assesses male lower urinary tract symptoms and impact on quality of life. It consists of 13 items covering 2 domains, namely voiding symptoms and incontinence symptoms. The voiding symptoms subscale is the sum of item 2 to 6, while the incontinence symptoms subscale is the sum of item 7-12. The lowest possible score is 0 for both subscales, while the highest possible score is 20 for voiding symptoms subscale and 24 for incontinence symptoms subscale. The higher the score, the more symptomatic
Time frame: Once at screening visit
International Prostate Symptom Score (IPSS)
The IPSS ("International Prostate Symptom Questionnaire") score is based on questions concerning urinary symptoms and quality of life (QoL). It consists of 8 items covering 7 urinary symptoms related dimensions (subscales) and 1 additional item assessing quality of life. Each item is rated on a 6-point scale (0=not at all; 5=almost always). The lowest possible score in the total IPSS score is 0 (asymptomatic); the highest possible score is 35 (symptomatic). The QoL index is rated on a 7-point scale, with 0 indicating "delighted" and 6 "terrible."
Time frame: Once at screening visit
International Index of Erectile Function (IIEF) questionnaire
The IIEF ("International Index of Erectile Function") is based on questions concerning erectile dysfunction. It consists of 15 items covering 5 domains, namely erectile functioning, orgasmic functioning, sexual desire, and intercourse satisfaction along with a fifth component which encompasses the concept of overall sexual satisfaction. While items 1-10 are rated on a 6-point Likert-type scale from 0 to 5, items 11-15 are rated on a 5-point Likert-type scale from 1 to 5. Higher scores are reflecting less dysfunction. Domain scores are computed by summing the sores for individual items in each domain.
Time frame: Once at screening visit
Female Sexual Functioning Index (FSFI) questionnaire
The FSFI ("Female Sexual Function Index") is based on questions concerning female sexual functions. It consists of 19 items covering 6 domains, namely sexual desire, arousal (both subjective and physiologic), lubrication, orgasm, satisfaction, and pain. The lowest possible score in the total FSFI is 2 (asymptomatic); the highest possible score is 36 (symptomatic).
Time frame: Once at screening visit
Qualiveen questionnaire
Qualiveen-30 assesses the Specific Impact of Urinary Problems (SIUP) on Quality of Life. It consists of 30 items covering 4 domains, namely inconvenience (9 questions), restrictions (8 questions), fears (8 questions), and impact on daily life (5 questions). Each item is rated on a 5-point ordinal scale (0=asymptomatic; 4=symptomatic). The index of the SIUP on Quality of Life is the mean of the four individual scores. The lowest possible overall score in the Qualiveen-30 is 0 (Urinary problems have no specific impact on QoL); the highest possible score is 30 (Urinary problems have a huge specific impact on QoL).
Time frame: Once at screening visit
Lower Urinary Tract Symptoms Quality of Life (LUTS-qol) questionnaire
The LUTS-qol ("International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life Module") questionnaire assesses the impact of lower urinary tract symptoms on quality of life. It consists of 20 items. The lowest possible score is 19, while the highest possible score is 76. Greater values are indicating increasing impact on quality of life.
Time frame: Once at screening visit
Swiss German Overactive Bladder (OAB) questionnaire
The Swiss German OAB (Swiss German Overactive Bladder) questionnaire assesses to what extent certain bladder symptoms complicated life. It consists of 19 items covering 2 domains, namely symptom bother and health-related quality of life. Each item is rated on an ordinal scale (1-6). The symptom bother score is the sum of item 1 to 6, while the health-related quality of life score is the sum of 13 items. For both domains, the lowest possible score is 0 (no problem), while the highest possible score is 36 for the symptom bother score and 78 for the health-related quality of life score.
Time frame: Once at screening visit
Hospital Anxiety and Depression Scale (HADS) questionnaire
The HADS assesses anxiety and depression. It consists of 14 items covering 2 domains, namely anxiety (7 items) and depression (7 items). Each item is rated on an ordinal scale (0-3). An index is separately calculated for the anxiety and depression items. The lowest possible score for anxiety and depression is 0, the highest possible score is 21. A score \<8 is considered as normal.
Time frame: Once at screening visit
MoCA test
The MoCA ("Montreal Cognitive Assessment") is a screening assessment for detecting cognitive impairment. The lowest possible score is 0, the highest possible score is 31. A score \>26 is considered as normal.
Time frame: Once at screening visit
Safety outcomes: Incidence of side effects as well as number and intensity/severity (mild/moderate/severe) of adverse events (AE) and serious adverse events (SAE) (Follow-up)
Assessed by a 3-day bladder diary
Time frame: Through study completion until two weeks after last measurement
Mean oral fluid intake in mL
Assessed by a 3-day bladder diary
Time frame: Once at screening visit
Number of voids per 24 hours
Assessed by a 3-day bladder diary
Time frame: Once at screening visit
Number of daytime voids
Assessed by a 3-day bladder diary
Time frame: Once at screening visit
Number of nighttime voids
Assessed by a 3-day bladder diary
Time frame: Once at screening visit
Number of intermittent catheterizations per 24h
Assessed by a 3-day bladder diary
Time frame: Once at screening visit
Number of daytime, intermittent catheterizations per 24h
Assessed by a 3-day bladder diary
Time frame: Once at screening visit
Number of nighttime, intermittent catheterizations per 24h
Assessed by a 3-day bladder diary
Time frame: Once at screening visit
Mean voided volume in mL
Assessed by a 3-day bladder diary
Time frame: Once at screening visit
Mean catheterized post void residual volume in mL
Assessed by a 3-day bladder diary
Time frame: Once at screening visit
Pain level score (0 none - 10 worst possible)
Assessed by a 3-day bladder diary
Time frame: Once at screening visit
Level of urgency (0 none - 4 severe with incontinence)
Assessed by a 3-day bladder diary
Time frame: Once at screening visit
Number of leakages per 24 hours
Assessed by a 3-day bladder diary
Time frame: Once at screening visit
Urine leakage (none-heavy)
Assessed by a 3-day bladder diary
Time frame: Once at screening visit
Number of used pads per 24 hours
Assessed by a 3-day bladder diary
Time frame: Once at screening visit
Wetness of pads (dry-soaked)
Assessed by a 3-day bladder diary
Time frame: Once at screening visit