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Completed

NCT Number: NCT03520166

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

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

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Key information

Conditions

Urinary Bladder, Overactive Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms Urinary Bladder Diseases Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medium frequency electrotherapy (interferential currents)

Other

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

Other

No treatment

Primary outcomes

  1. urgency

    Time frame: 24 hours

    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.

Secondary outcomes

  1. urge urinary incontinence

    Time frame: 24 hours

    is the complaint of involuntary leakage accompanied by or immediately preceded by urgency. Measured with 24 hour voiding diary.

  2. increased daytime frequency

    Time frame: 24 hours

    is the complaint by the patient who considers that he/she voids too often by day. Measured with 24 hour voiding diary.

  3. nocturia

    Time frame: 24 hours

    is the complaint that the individual has to wake at night one or more times to void. Measured with 24 hour voiding diary.

  4. increased bladder sensation

    Time frame: 24 hours

    the individual feels an early and persistent desire to void. Measured with 24 hour voiding diary.

  5. feeling of incomplete emptying

    Time frame: 24 hours

    is a self-explanatory term for a feeling experienced by the individual after passing urine. Measured with 24 hour voiding diary.

  6. nocturnal enuresis

    Time frame: 24 hours

    is the complaint of loss of urine occurring during sleep. Measured with 24 hour voiding diary.

  7. incontinence

    Time frame: 24 hours

    is the complaint of any involuntary leakage of urine. Measured with 24 hour voiding diary.

  8. pelvic pain

    Time frame: 24 hours

    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.

Sponsors and collaborators

Lead sponsor

Fisioterapia Pélvica Avanzada Madrid, SRL

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
May 9, 2018
Registry last updated
May 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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