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

Lower Urinary Tract Symptoms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03520166
• Other study ID #: FPA01/2014
• Secondary ID: 1.010.817
• Status: Completed
• Phase: N/A
• Start date: January 10, 2014
• Est. completion date: June 30, 2017

Study information

• Verified date: April 2018
• Source: Fisioterapia Pélvica Avanzada Madrid, SRL
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 30, 2017
• Est. primary completion date: June 15, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Medium frequency electrotherapy (interferential currents)
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.
• No treatment
No treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fisioterapia Pélvica Avanzada Madrid, SRL

References & Publications (2)

Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, Van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-Committee of the International Continence Society. The standardisation of terminology in lower urinary tract function: report from the — View Citation

Almeida CC, Silva VZMD, Júnior GC, Liebano RE, Durigan JLQ. Transcutaneous electrical nerve stimulation and interferential current demonstrate similar effects in relieving acute and chronic pain: a systematic review with meta-analysis. Braz J Phys Ther. 2018 Feb 2. pii: S1413-3555(17)30283-6. doi: 10.1016/j.bjpt.2017.12.005. [Epub ahead of print] Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	urge urinary incontinence	is the complaint of involuntary leakage accompanied by or immediately preceded by urgency. Measured with 24 hour voiding diary.	24 hours
Secondary	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
Secondary	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
Secondary	increased bladder sensation	the individual feels an early and persistent desire to void. Measured with 24 hour voiding diary.	24 hours
Secondary	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
Secondary	nocturnal enuresis	is the complaint of loss of urine occurring during sleep. Measured with 24 hour voiding diary.	24 hours
Secondary	incontinence	is the complaint of any involuntary leakage of urine. Measured with 24 hour voiding diary.	24 hours
Secondary	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