Comparison of the Efficacy of Transcutaneos Nerve Stimulations in Women With Idiopathic Overactive Bladder

April 1, 2024 updated by: Necmettin Yildiz, Pamukkale University

Comparison of the Efficacy of Transcutaneos Medial Plantar Nerve and Tibial Nerve Stimulation in Women With Idiopathic Overactive Bladder: A Prospective Randomized Controlled Trial

Our study is the first prospective randomized controlled trial that compares the effectiveness of transcutaneous medial plantar nerve stimulation (T-MPNS) and transcutaneous tibial nerve stimulation (TTNS) added to bladder training (BT) in women with idiopathic overactive bladder (OAB). İn this study, we aimed to assess the efficacy of T-MPNS and TTNS added to BT on quality of life (QoL) and clinical parameters asssociated with idiopathic OAB. In addition, preparation time for stimulation, treatment satisfaction and discomfort levels of the patients were evaluated.

The main questions we aim to answer are:

Is T-MPNS as effective as TTNS in the treatment of idiopathic OAB? For this purpose, we planned to compare transcutaneous applications of the tibial and plantar medial nerve in women with idiopathic OAB. 60 women with OAB will be randomized to 3 groups by using random number generator: BT program alone to Group 1 (n=20), BT plus T-MPNS to Group 2 (n=20), BT plus TTNS to Group 3 (n=20) will be applied.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The main questions we aim to answer are:

Is T-MPNS as effective as TTNS in the treatment of idiopathic OAB? For this purpose, we planned to compare transcutaneous applications of the tibial and plantar medial nerve in women with idiopathic OAB. 60 women with OAB will be randomized to 3 groups by using random number generator: BT program alone to Group 1 (n=20), BT plus T-MPNS to Group 2 (n=20), BT plus TTNS to Group 3 (n=20) will be applied.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Denizli, Turkey
        • Pamukkale University

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Women over the age of 18 with clinical diagnosis of idiopathic OAB
  • Not tolerated or unresponsive to antimuscarinics and discontinued at least 4 weeks
  • Able to understand the procedures, advantages and possible side effects
  • Willing and able to complate the voiding diary and QoL questionnaire
  • The strength of PFM 3/5 and more

Exclusion Criteria:

  • Women with stress urinary incontinence
  • History of conservative therapy (BT, T-MPNS and TTNS/PTNS) within 6 months
  • Pregnancy or intention to become pregnant during the study
  • Current vulvovaginitis or urinary tract infections or malignancy
  • Anatomic or posttraumatic malformations/skin disorders of medial plantar/tibial nerve region on inner foot/ankle that cannot allow to apply the electrodes
  • More than stage 2 according to the pelvic organ prolapse quantification (POP-Q)
  • Cardiac pacemaker, implanted defibrillator
  • Previous urogyneceological surgery within 3 months
  • Neurogenic bladder, signs of neurologic abnormalities at objective examination; history of the peripheral or central neurologic pathology
  • Ultrasonographic evidence of PVR volume more than 100 ml

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BT plus T-MPNS
T-MPNS sessions will be performed twice a week for 6 weeks. Each session will be lasted 30 minutes. The intervention will be included a 12-session BT plus T-MPNS treatment program
Other: Transcutaneous MPN stimulation (T-MPNS)
Transcutaneous MPN stimulation (T-MPNS) is the electrostimulation of the lumbosacral roots that produce an activation of the lumbosacral plexus that controls the visceral organs and the pelvic floor muscles, thereby improving bladder control.
Experimental: BT plus TTNS
TTNS sessions will be performed twice a week for 6 weeks. Each session will be lasted 30 minutes. The intervention will be included a 12-session BT plus TTNS treatment program
Other: Transcutaneous tibial nerve stimulation (TTNS)
Transcutaneous tibial nerve stimulation (TTNS) is the electrostimulation of the lumbosacral roots that produce an activation of the lumbosacral plexus that controls the visceral organs and the pelvic floor muscles, thereby improving bladder control.
Active Comparator: BT (Control group)
Information about BT will be explained to patients for 30 min. Then written form about BT will be given to be implemented as a home program.
Other: BT (Control group)
Conventional bladder training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in incontinence episodes (positive response rate)
Time Frame: Change from baseline positive response rate at the 6th week after the treatment
Reduction in incontinence episodes will be collected from the 3-day bladder diary. Woman with ≥50% reduction in incontinence episodes were considered positive responders
Change from baseline positive response rate at the 6th week after the treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The severity of incontinence
Time Frame: Change from baseline the 24-hour pad test at the 6th week after the treatment
The 24-hour pad test will be carried out to evaluate the severity of incontinence
Change from baseline the 24-hour pad test at the 6th week after the treatment
Symptom severity
Time Frame: Change from baseline Overactive Bladder Questionnaire (OAB-V8) at the 6th week after the treatment
Overactive Bladder Questionnaire (OAB-V8) was used to evaluate symptom severity in women with OAB
Change from baseline Overactive Bladder Questionnaire (OAB-V8) at the 6th week after the treatment
Frequency of voiding, nocturia, number of pads
Time Frame: Change from baseline voiding, nocturia, and the number of pads used will be collected from the 3-day bladder diary at the 6th week after the treatment
The frequency of voiding, nocturia, and the number of pads used will be collected from the 3-day bladder diary.
Change from baseline voiding, nocturia, and the number of pads used will be collected from the 3-day bladder diary at the 6th week after the treatment
Quality of life (IIQ7)
Time Frame: Change from baseline point of The Quality of Life-Incontinence Impact Questionnaire at the 6th week after the treatment
The Quality of Life-Incontinence Impact Questionnaire (IIQ7)
Change from baseline point of The Quality of Life-Incontinence Impact Questionnaire at the 6th week after the treatment
The Hospital Anxiety and Depression Scale (HAD)
Time Frame: Change from baseline point of The Hospital Anxiety and Depression Scale (HAD) at the 6th week after the treatment
The Hospital Anxiety and Depression Scale (HAD), developed by Zigmond and Snaith in 1983, with its validity and reliability study conducted in Turkey by Aydemir et al. in 1987, assesses anxiety and depression levels. It consists of 14 questions, seven for anxiety and seven for depression, scored on a four-point Likert scale. Scores are summed for each subscale: 1, 3, 5, 7, 9, 11, and 13 for anxiety, and 2, 4, 6, 8, 10, 12, and 14 for depression. In Turkey, cutoff scores are 10/11 for anxiety and 7/8 for depression, indicating risk.
Change from baseline point of The Hospital Anxiety and Depression Scale (HAD) at the 6th week after the treatment
FSFI
Time Frame: Change from baseline point of FSFI at the 6th week after the treatment
In the evaluation of sexual function, the FSFI questionnaire is used, consisting of 19 questions assessing six main factors: sexual desire, arousal, lubrication, orgasm, satisfaction, and pain/discomfort. The highest possible total raw score is 95, while the lowest is 4. After multiplying the coefficients, the highest score is 36, and the lowest is 2. Impact coefficients used for scoring are: 0.6 for sexual desire, 0.3 for arousal and lubrication, and 0.4 for orgasm, satisfaction, and pain/discomfort. An FSFI score below 26.55 is indicative of sexual dysfunction
Change from baseline point of FSFI at the 6th week after the treatment
Cure-improvement rates
Time Frame: Change from baseline cure and improvements at the 6th week after the treatment
Cure and improvement rates will be recorded in all groups at the end-of-treatment assessments. Values under 1.3 g in the 24-hour pad test will be considered as "cure", while a 50% or greater reduction in wet weight compared to baseline measurements at the end of treatment will be considered as "improvement"
Change from baseline cure and improvements at the 6th week after the treatment
Treatment satisfaction
Time Frame: Change from baseline of their urinary incontinence on a 5-point Likert scale at the 6th week after the treatment
The change of their urinary incontinence on a 5-point Likert scale (5, very satisfied; 1, very unsatisfied)
Change from baseline of their urinary incontinence on a 5-point Likert scale at the 6th week after the treatment

Collaborators and Investigators

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

Sponsor

Pamukkale University

Investigators

  • Study Director: Necmettin Yıldız, Prof., Pamukkale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

April 22, 2024

Primary Completion (Estimated)

January 31, 2025

Study Completion (Estimated)

February 28, 2025

Study Registration Dates

First Submitted

April 1, 2024

First Submitted That Met QC Criteria

April 1, 2024

First Posted (Actual)

April 5, 2024

Study Record Updates

Last Update Posted (Actual)

April 5, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PamukkaleU.ftr-NYıldız-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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