Use of Medium Frequency Electrotherapy in the Treatment of OAB, LUTS and Pelvic Pain

Study Overview
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Brief Summary
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The aim of this study is to assess the effectiveness of medium frequency electrotherapy (interferential currents) treatment for overactive bladder (OAB), lower urinary tract symptoms (LUTS) and pelvic pain

Detailed Description
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This study consists of 100 women, complaining of increased bladder sensation and urgency with or without incontinence as principal symptomatology and who had not received previous pharmacological treatment. Group-A was used as a control group (n = 50). Group-B patients received 18 sessions of medium frequency electrotherapy during 9 weeks, 2 weekly sessions

Official Title
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Treatment of Overactive Bladder, Lower Urinary Tract Symptoms and Pelvic Pain With Medium Frequency Electrotherapy (Interferential Currents)

Conditions
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Urinary Bladder, Overactive, Lower Urinary Tract Symptoms, Pelvic Pain

Intervention / Treatment
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* Other: Medium frequency electrotherapy (interferential currents)
* Other: No treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Increased bladder sensation Urgency Overactive bladder Lower urinary tract symptoms Pelvic pain Exclusion Criteria: Neurogenic bladder Acute urinary infection Pelvic floor surgery Congenital urological malformations Age less than 18 years Bladder organic pathology Pelvic radiotherapy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Quasi-experimental, longitudinal, pre-/post-. Level of evidence II/III.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group-A<br>No treatment | Other: No treatment<br>* No treatment<br>|
| Experimental: Group-B<br>Medium frequency electrotherapy (interferential currents) | Other: Medium frequency electrotherapy (interferential currents)<br>* Treatment with medium frequency electrotherapy, interferential currents between 5500 Hz and 8500 Hz (Combi-200®, Gymna®), was performed using transvaginal application. The frequency was increased progressively over the first six sessions (twice a week), starting with a frequency of 5500 Hz until reaching a frequency of 8500 Hz, which remained until the end of treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| urgency | with or without urge incontinence, usually with frequency and nocturia, can be described as the overactive bladder syndrome, urge syndrome or urgency-frequency syndrome. Measured with 24 hour voiding diary. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| urge urinary incontinence | is the complaint of involuntary leakage accompanied by or immediately preceded by urgency. Measured with 24 hour voiding diary. | 24 hours | 
| increased daytime frequency | is the complaint by the patient who considers that he/she voids too often by day. Measured with 24 hour voiding diary. | 24 hours | 
| nocturia | is the complaint that the individual has to wake at night one or more times to void. Measured with 24 hour voiding diary. | 24 hours | 
| increased bladder sensation | the individual feels an early and persistent desire to void. Measured with 24 hour voiding diary. | 24 hours | 
| feeling of incomplete emptying | is a self-explanatory term for a feeling experienced by the individual after passing urine. Measured with 24 hour voiding diary. | 24 hours | 
| nocturnal enuresis | is the complaint of loss of urine occurring during sleep. Measured with 24 hour voiding diary. | 24 hours | 
| incontinence | is the complaint of any involuntary leakage of urine. Measured with 24 hour voiding diary. | 24 hours | 
| pelvic pain | is less well defined than, for example, bladder, urethral or perineal pain and is less clearly related to the micturition cycle or to bowel function and is not localised to any single pelvic organ. Measured with pain visual analogic pain scale single-item scale. | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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urgency, frequency, overactive bladder, LUTS, pelvic pain, electrostimulation