Comparison of Two Forms of Transcutaneous Electrical Stimulation in Overactive Bladder

Overactive Bladder Clinical Trial

Official title:

Comparison of Parasacral Transcutaneous Electrical Stimulation With Transcutaneous Posterior Tibial Nerve Stimulation in Women With Overactive Bladder: a Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03742206
• Other study ID #: 17-0056
• Status: Recruiting
• Phase: N/A
• Start date: January 25, 2018
• Est. completion date: October 2019

Study information

• Verified date: October 2018
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Mallmann
• Phone: +5551996261820
• Email: suzana_mallmann[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Aim: To compare the effects of parasacral transcutaneous electrical stimulation with transcutaneous posterior tibial nerve stimulation on the symptoms of Overactive Bladder in women.

Study's hypothesis: The use of the parasacral transcutaneous electrical stimulation technique presents better results regarding the remission of overactive bladder symptoms in relation to transcutaneous posterior tibial nerve stimulation.

Description:

Search location: The data will collected at the Ambulatory of Urogynecology and Obstetrics of Porto Alegre Clinical Hospital (HCPA), where the activities of Pelvic Physiotherapy are performed

Main outcome: to measure changes in urinary urgency and quality of life.

Secondary outcome: to measure changes in the severity of urinary incontinence and the symptom bother.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: October 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of overactive bladder with or without the presence of urinary incontinence.

• Understand the instruments used in the research.

Exclusion Criteria:

• Urinary tract infection

• Neurological disease

• Other previous treatment in the last four weeks

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive
• Urinary Incontinence, Urge
• Urinary Urge Incontinence

Intervention

Device:
• Parasacral Transcutaneous Electrical Stimulation
Electrical stimulation with surface electrodes on the sacral roots of S3 that produce inferior urinary tract neuromodulation.
• Transcutaneous Posterior Tibial Nerve Stimulation
Electrical stimulation with surface electrodes through the activation of peripheral afferent nerves that produce inferior urinary tract neuromodulation

Locations

Country	Name	City	State
Brazil	Suzana Mallmann	Porto Alegre	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of treatment in quality of life	Application of the King's Health Questionnaire (KHQ). KHQ is an instrument for measuring quality of life in people diagnosed with urinary incontinence, consisting of 30 objective questions distributed in 9 domains. In each question, values are assigned according to the intensity of the patient's complaint (0 = not applicable, 1 = no; 2 = a little / sometimes, 3 = more or less / several times, 4 = a lot / always). The final score is calculated individually for each domain and ranges from 0 to 100, the highest score being related to a poorer quality of life.	six weeks
Secondary	Severity of urinary incontinence	Application of the Incontinence Severity Index. It is a brief instrument, consisting of two questions regarding the frequency and amount of urinary loss. The final score obtained by multiplying the frequency scores by the amount of urinary loss allows the incontinence urinary to be classified as mild (final score 1-2), moderate (final score 3-6 ), severe (final score 8-9) and very severe (final score 12).	six weeks
Secondary	Severity of overactive bladder symptoms	Application of the Symptom Bother Scale. It instrument asks how bothered the patient is by the 4 hallmark symptoms of overactive bladder: urinary frequency, urgency, nocturia, and urge incontinence. Patients respond on a 6-point Likert scale ranging from 0 (not at all) to 5 (a very great deal), with a maximum possible score of 40, calculated by adding all responses.	six weeks