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

NCT03520166 | Completed

• 2 other identifiers: FPA01/20141.010.817
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

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

Keywords

urgency; frequency; overactive bladder; LUTS; pelvic pain; electrostimulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• urge urinary incontinence

  24 hours

• increased daytime frequency

  24 hours

• nocturia

  24 hours

• increased bladder sensation

  24 hours

• feeling of incomplete emptying

  24 hours

Study Arms (2)

Group-A

PLACEBO COMPARATOR

No treatment

Other: No treatment

Group-B

EXPERIMENTAL

Medium frequency electrotherapy (interferential currents)

Other: Medium frequency electrotherapy (interferential currents)

Interventions

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.

Group-B

No treatment OTHER

No treatment

Group-A

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Increased bladder sensation Urgency Overactive bladder Lower urinary tract symptoms Pelvic pain

You may not qualify if:

• Neurogenic bladder Acute urinary infection Pelvic floor surgery Congenital urological malformations Age less than 18 years Bladder organic pathology Pelvic radiotherapy

Sponsors & Collaborators

• Fisioterapia Pélvica Avanzada Madrid, SRL: lead

Related Publications (2)

• Almeida CC, Silva VZMD, Junior 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 Sep-Oct;22(5):347-354. doi: 10.1016/j.bjpt.2017.12.005. Epub 2018 Feb 2.

  PMID: 29426587 BACKGROUND

• 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 standardisation sub-committee of the International Continence Society. Urology. 2003 Jan;61(1):37-49. doi: 10.1016/s0090-4295(02)02243-4. No abstract available.

  PMID: 12559262 RESULT

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations

Study Officials

• Cristina Naranjo-Ortiz, Ph.D

  Fisioterapia Pelvica Avanzada Madrid, SRL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Type inclusion was consecutively type
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Quasi-experimental, longitudinal, pre-/post-. Level of evidence II/III.

Study Record Dates

• First Submitted: April 16, 2018
• First Posted: May 9, 2018
• Study Start: January 10, 2014
• Primary Completion: June 15, 2017
• Study Completion: June 30, 2017
• Last Updated: May 9, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share