Comparison of the Effects of Transcutaneous Electrical Nerve Stimulation Protocols in Women With Overactive Bladder

January 3, 2023 updated by: seyda toprak celenay, Ankara Yildirim Beyazıt University
The aim of our study is a comparison of the effects of transcutaneous electrical nerve stimulation (TENS) protocols in women with overactive bladder (OAB).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

OAB is a condition defined by the International Continence Society as the presence of urinary urgency, usually accompanied by frequency and nocturia, with or without urgency urinary incontinence, in the absence of urinary tract infection or other obvious pathology. TENS has positive effects on OAB. However, there are not enough studies on how often this stimulation is applied. Studies are needed on this subject.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Being in the age range of 18-65 ,
  • Having diagnosed with OAB,
  • Being a volunteer

Exclusion Criteria:

  • Being pregnant,
  • presence of severe pelvic organ prolapse,
  • malignant disease,
  • urinary infection,
  • neurological disease,
  • have electronic and metal implant,
  • loss of sensation,
  • lumbosacral peripheral nerve lesion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
Group 1 will be applied TENS three days per week
Other: TENS 1
Parasacral TENS will be applied for 30 minutes 3 days a week during 6 weeks.
Active Comparator: Group 2
Group 2 will be applied TENS one day per week
Other: TENS 2
Parasacral TENS will be applied for 30 minutes one day a week during 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overactive bladder symptoms
Time Frame: change from baseline at 3 weeks and 6 weeks
Overactive bladder symptoms will be assessed with the Overactive Bladder-V8 Questionnaire
change from baseline at 3 weeks and 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urgency severity
Time Frame: change from baseline at 3 weeks and 6 weeks
Urgency severity will be assessed with Patients' Perception of Intensity of Urgency Scale
change from baseline at 3 weeks and 6 weeks
Bladder functions
Time Frame: change from baseline at 3 weeks and 6 weeks
Bladder functions will be assessed with voiding diary
change from baseline at 3 weeks and 6 weeks
Life quality
Time Frame: change from baseline at 3 weeks and 6 weeks
Life quality will be assessed with the King's Health Questionnaire
change from baseline at 3 weeks and 6 weeks
Strength of pelvic floor muscle
Time Frame: change from baseline at 3 weeks and 6 weeks
Strength of pelvic floor muscle will be assessed with Modified Oxford Scale
change from baseline at 3 weeks and 6 weeks
Perception of recovery
Time Frame: change from baseline at 3 weeks and 6 weeks
Perception of recovery will be assessed with a 4-point Likert scale
change from baseline at 3 weeks and 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara Yildirim Beyazıt University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 15, 2023

Primary Completion (Anticipated)

June 15, 2023

Study Completion (Anticipated)

February 15, 2024

Study Registration Dates

First Submitted

January 3, 2023

First Submitted That Met QC Criteria

January 3, 2023

First Posted (Actual)

January 5, 2023

Study Record Updates

Last Update Posted (Actual)

January 5, 2023

Last Update Submitted That Met QC Criteria

January 3, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023/01/02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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