Urinary Bladder, OveractiveNCT03520166
Use of Medium Frequency Electrotherapy in the Treatment of OAB, LUTS and Pelvic Pain
A study testing Medium frequency electrotherapy (interferential currents) and No treatment in people with Urinary Bladder, Overactive and Lower Urinary Tract Symptoms, run by Fisioterapia Pélvica Avanzada Madrid, SRL.
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 Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Bladder, Overactive, Lower Urinary Tract Symptoms, Pelvic Pain
- What is being tested?
- Medium frequency electrotherapy (interferential currents) and No treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2014to 30 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Increased bladder sensation Urgency Overactive bladder Lower urinary tract symptoms Pelvic pain
Who cannot join
- Neurogenic bladder Acute urinary infection Pelvic floor surgery Congenital urological malformations Age less than 18 years Bladder organic pathology Pelvic radiotherapy
About this study
Official title: Treatment of Overactive Bladder, Lower Urinary Tract Symptoms and Pelvic Pain With Medium Frequency Electrotherapy (Interferential Currents)
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
Read the detailed 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
- Being tested
- Medium frequency electrotherapy (interferential currents), No treatment
- Keywords
- urgency, frequency, overactive bladder, LUTS, pelvic pain, electrostimulation
- Medical subject headings
- Urinary Bladder, Overactive, Lower Urinary Tract Symptoms, Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 treatmentOther
No treatment
| Study group | Role | What they receive |
|---|---|---|
| Group-A | Placebo comparator | No treatment Receives: Other: No treatment |
| Group-B | Experimental | Medium frequency electrotherapy (interferential currents) Receives: Other: Medium frequency electrotherapy (interferential currents) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Secondary outcomes (8)
urge urinary incontinence
is the complaint of involuntary leakage accompanied by or immediately preceded by urgency. Measured with 24 hour voiding diary.
Measured: 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.
Measured: 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.
Measured: 24 hours
increased bladder sensation
the individual feels an early and persistent desire to void. Measured with 24 hour voiding diary.
Measured: 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.
Measured: 24 hours
nocturnal enuresis
is the complaint of loss of urine occurring during sleep. Measured with 24 hour voiding diary.
Measured: 24 hours
incontinence
is the complaint of any involuntary leakage of urine. Measured with 24 hour voiding diary.
Measured: 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.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2018
- Study start10 Jan 2014
- Primary completion15 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Urinary Bladder, OveractiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Quasi-experimental, longitudinal, pre-/post-. Level of evidence II/III.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fisioterapia Pélvica Avanzada Madrid, SRL
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristina Naranjo Ortiz, Fisioterapia Pélvica Avanzada Madrid, SRL
- Investigators
- Cristina Naranjo-Ortiz, Ph.D, Principal investigator, Fisioterapia Pelvica Avanzada Madrid, SRL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03520166
- Sponsor's protocol ID
- FPA01/2014
- Other IDs
- 1.010.817
- Status last verified
- Apr 2018
- First submitted
- 16 Apr 2018
- Last updated
- 9 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers
Publications
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.
PubMed 29426587Abrams 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.
PubMed 12559262
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Overactive Bladder, Lower Urinary Tract Symptoms and Pelvic Pain With Medium Frequency Electrotherapy (Interferential Currents)
- ClinicalTrials.gov ID
- NCT03520166
- Acronym / sponsor ID
- FPA01/2014
- Keywords
- urgency, frequency, overactive bladder, LUTS, pelvic pain, electrostimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Fisioterapia Pélvica Avanzada Madrid, SRLUniversity, hospital or other
- Study start
- 10 Jan 2014 (actual)
- Primary completion
- 15 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 9 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Quasi-experimental, longitudinal, pre-/post-. Level of evidence II/III.
| Arm | Type | Receives |
|---|---|---|
| Group-A | Placebo comparator | Other: No treatmentNo treatment |
| Group-B | Experimental | Other: Medium frequency electrotherapy (interferential currents)Medium frequency electrotherapy (interferential currents) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Increased bladder sensation Urgency Overactive bladder Lower urinary tract symptoms Pelvic pain
Key exclusion criteria (1 listed)
- Neurogenic bladder Acute urinary infection Pelvic floor surgery Congenital urological malformations Age less than 18 years Bladder organic pathology Pelvic radiotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Group-B |
| No treatmentNo treatment | Other | Group-A |
Primary outcome
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.
8 secondary outcomes
urge urinary incontinence
Time frame: 24 hours
increased daytime frequency
Time frame: 24 hours
nocturia
Time frame: 24 hours
increased bladder sensation
Time frame: 24 hours
feeling of incomplete emptying
Time frame: 24 hours
nocturnal enuresis
Time frame: 24 hours
incontinence
Time frame: 24 hours
pelvic pain
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2018.
- Background: PubMed 29426587Almeida 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.
- Results publication: PubMed 12559262Abrams 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers
Related trials for Urinary Bladder, Overactive
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Urinary Incontinence, Overactive Bladder Syndrome
Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary Incontinence, Urge Incontinence
Active, not recruitingObservational study
Overactive Bladder Symptoms and Urinary Incontinence In Women With Rheumatoid Arthritis
Rheumatoid Arthritis, Rheumatoid Arthritis (RA)
RecruitingObservational study
Predictive Value of Inflammatory Biomarkers for Mirabegron Response in Women With Overactive Bladder
Overactive Bladder (OAB)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cristina Naranjo-Ortiz, Ph.D principal investigator
Fisioterapia Pelvica Avanzada Madrid, SRL
Questions about this trial
What is this clinical trial studying?
A study testing Medium frequency electrotherapy (interferential currents) and No treatment in people with Urinary Bladder, Overactive and Lower Urinary Tract Symptoms, run by Fisioterapia Pélvica Avanzada Madrid, SRL.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
urgency (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03520166, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2018.