Efficacy of Parasacral Transcutaneous Electrical Nerve Stimulation in the Treatment of Patients with Overactive Bladder Syndrome: A Single Blinded Randomized Controlled Trial
Comparison of quality of life improvement related to OAB in the group treated with parasacral TENS compared to the SHAM group and pharmacological treatment, categorized by time periods before and after treatment
Design
A clinical trial with a control group, parallel groups, single-blind, randomized involving 75 patients.
Settings and conduct
Al-Zahra Women's Hospital, Tabriz - Women's Fertility Health Research Center
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Individuals aged 18 years or older with OAB.
Participants must have experienced symptoms for at least three months and provide informed consent.
Exclusion Criteria:
Individuals with neurological disorders affecting bladder function.
Patients currently receiving other pharmacological treatments for OAB or those who have recently undergone bladder surgery.
Pregnant or breastfeeding women.
Individuals with stress or mixed incontinence.
Intervention groups
In this study, pelvic floor muscle training exercises will be implemented for both groups using the PFMT protocol. This will last for 6 to 8 weeks, where each set includes three exercises with ten repetitions each. Additionally, Transcutaneous Electrical Nerve Stimulation (TENS) will be employed, utilizing two surface electrodes placed on the S3 and S2 areas. The study will include 24 TENS sessions conducted three times a week for 8 weeks. TENS will operate at a frequency of 10 Hz and pulse durations of 500 to 700 microseconds. In the experimental group, only the parasacral electrodes will be active, while in the SHAM group, the device will be used without current.
Main outcome variables
Changes in the severity of overactive bladder (OAB) symptoms are assessed using the following validated questionnaires:
ICIQ-OAB Questionnaire -ICIQ-UI SF Questionnaire -Voiding Diary Form -LUTS-QoL Questionnaire
FSFI Questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20241122063802N1
Registration date:2025-02-09, 1403/11/21
Registration timing:prospective
Last update:2025-02-09, 1403/11/21
Update count:0
Registration date
2025-02-09, 1403/11/21
Registrant information
Name
Reza Sattarpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3553 9161
Email address
rezasattarpour.tums@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-02-19, 1403/12/01
Expected recruitment end date
2026-02-20, 1404/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Parasacral Transcutaneous Electrical Nerve Stimulation in the Treatment of Patients with Overactive Bladder Syndrome: A Single Blinded Randomized Controlled Trial
Public title
Efficacy of Parasacral Transcutaneous Electrical Nerve Stimulation in the Treatment of Patients with Overactive Bladder Syndrome: A Single Blinded Randomized Controlled Trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Individuals aged 18 or older with Overactive Bladder (OAB) who have experienced urinary urgency, frequency (more than eight times a day), nocturia (waking up more than twice at night), and/or urgency urinary incontinence (an average of eight or more urinations in 24 hours and three or more urgencies, with severity levels of 3—severe urgency or 4—urgency incontinence) with or without incontinence over a period of three days.
Participants must have experienced symptoms for at least three months and provide informed consent.
Exclusion criteria:
- Individuals with neurological disorders affecting bladder function
- Patients currently receiving other medications for OAB or those who have recently undergone bladder surgery.
Pregnant or breastfeeding women
Individuals with stress or mixed incontinence
Presence of a urinary catheter
Evidence of a symptomatic urinary tract infection, chronic bladder inflammation, or stones
Previous pelvic radiation therapy, or current malignancy
Patients with implanted electronic devices (such as pacemakers)
Those with active skin infections or lesions at the electrode placement site.
Individuals with epilepsy or a history of seizures
Patients with severe cardiac conditions or other serious systemic diseases
High blood pressure is defined as systolic blood pressure (SBP) greater than 180 mmHg or diastolic blood pressure (DBP) greater than 110 mmHg.
Age
From 18 years old to 75 years old
Gender
Female
Phase
N/A
Groups that have been masked
Investigator
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Patients with overactive bladder will be randomly assigned to two separate groups using a method called Balanced Block Randomization. This method allows for random assignment in such a way that the study groups are balanced in terms of baseline characteristics, clinical variables, and all potential confounding variables. In this study, the number of blocks will be ... and the size of each block will consist of 4 patients. Essentially, the arrangement within each block indicates the type of group/intervention for each patient. Random allocation was performed using STATA software version 14 by an epidemiologist. The list of blocks and their random allocation order is attached in the Excel file (Rand).
Blinding (investigator's opinion)
Single blinded
Blinding description
This study will be conducted as a randomized, single-blind, controlled clinical trial. Participants will include at least 75 patients diagnosed with overactive bladder, who will be randomly assigned by a methodologist (who will have no role in the final analysis) at the Al-Zahra Clinical Trial Center in Tabriz to one of three treatment groups: parasacral treatment, TENS, SHAM, and pharmacological treatment. The study will be blinded for the providers assessing the outcomes, while those administering the treatments will be aware of the type of treatment being given. Randomization will be carried out using a sealed, opaque envelope.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Azadi Street Golgasht Street Central Building of the University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2025-01-13, 1403/10/24
Ethics committee reference number
IR.TBZMED.REC.1403.894
Health conditions studied
1
Description of health condition studied
Overactive bladder
ICD-10 code
N32.81
ICD-10 code description
Overactive bladder
Primary outcomes
1
Description
ICIQ-OAB Score: A 4-item questionnaire with a score range of 0-16, where higher scores indicate greater severity of overactive bladder symptoms.Mild OAB: Total score of 5 or lessModerate OAB: Total score between 6 and 11Severe OAB: Total score of 12 or more.
Timepoint
Initially, 2 months and 4 months after treatment
Method of measurement
Using the valid and reliable Persian ICIQ-OAB questionnaire
2
Description
The score of the ICIQ-UI SF questionnaire: It is a 4-item questionnaire with a scoring range of 0-21. This questionnaire is used to evaluate the frequency, severity, and impact on quality of life of urinary incontinence in men and women in research and clinical practice worldwide. 0: No urinary incontinence exists. 1-5: Mild incontinence; may not have a significant impact on quality of life. 6-12: Moderate incontinence; likely affects daily activities. 13-21: Severe incontinence; has a significant impact on quality of life and daily functioning.
Timepoint
Initially, 2 months and 4 months after treatment
Method of measurement
Using the valid and reliable Persian ICIQ-UI SF questionnaire
3
Description
The LUTS-QoL questionnaire score: A 20-item questionnaire for evaluating the quality of life in individuals with urinary incontinence. The minimum and maximum scores on this questionnaire are 19 and 76, respectively, with lower scores indicating better quality of life.
Timepoint
Initially, 2 months and 4 months after treatment
Method of measurement
Using the valid and reliable Persian LUTS-QoL questionnaire
4
Description
The Female Sexual Function Index (FSFI) is a valid 19-question questionnaire that evaluates female sexual function in six domains. Higher scores indicate better sexual function. The total FSFI score is calculated by summing the scores of individual domains, with a maximum possible score of 36. Scores below 26.55 are typically considered indicative of sexual dysfunction.
Timepoint
Initially, 2 months and 4 months after treatment
Method of measurement
Using the valid and reliable Persian FSFI questionnaire
5
Description
The Voiding Diary form contains information such as the number of urination instances, the volume of urine passed, and the volume of fluids consumed by the patient over a period of at least 24 hours. The Voiding Diary form will be given to patients and they will be asked to complete it 72 hours before starting treatment (before the first therapy session) and 72 hours after completing treatment (after the last therapy session).
Timepoint
Initially, 2 months and 4 months after treatment
Method of measurement
Using the valid and reliable Persian Voiding diary
Secondary outcomes
1
Description
The occurrence and severity of any side effects related to treatment with parasacral TENS will be recorded and evaluated at the same time intervals (initially, 3 months, and 6 months after treatment). Therefore, the primary outcome of this study is the change in the severity of OAB symptoms, which will be measured using standard tools. Secondary outcomes will also include changes in quality of life and the occurrence of potential side effects resulting from the treatment.
Timepoint
Initially and at 2 and 4 months after treatment.
Method of measurement
The treatment is defined using treatment-emergent adverse events (TEAEs). A TEAE is defined as a side effect that begins after the start of the experimental drug treatment; or if the event has been ongoing from the beginning and has become serious, it is related to the experimental drug or has resulted in death, discontinuation, interruption, or reduction of the experimental treatment.
Intervention groups
1
Description
Intervention group: Intervention 1) Pelvic Floor Exercises This intervention will be the same for all groups to ensure that neither group is deprived of primary and supportive treatment. Both groups in the study will use pelvic floor muscle strengthening exercises following the protocol below. The exercises will follow the Progressive Supervised Pelvic Floor Muscle Training (PFMD) protocol, consisting of three sets throughout the day, with each set including three exercises and ten repetitions of each exercise for a duration of 6 to 8 weeks. Intervention 2) Parasacral Electrical Stimulation In this study, a device will be used for Transcutaneous Electrical Nerve Stimulation (TENS). Two surface electrodes, 3.5 centimeters in size, will be placed on each side of S3 and S2. The electrical energy will be generated by a generator. This method will consist of 24 TENS sessions. TENS will be performed three times a week for 8 weeks, with each session lasting 20 minutes. The frequency used will be 10 Hz, with pulse durations of 500-700 microseconds. The current intensity will be increased to the maximum level tolerable by the individual. In the experimental group, only the active parasacral electrodes will be used, while in the SHAM group, the device will be connected similarly without establishing current flow.
Category
Treatment - Other
2
Description
Control group: Intervention 1) Pelvic Floor Exercises This intervention will be the same for both groups to ensure that neither group is deprived of primary and supportive treatment. Both groups in the study will use pelvic floor muscle strengthening exercises following the protocol below. The exercises will follow the Progressive Supervised Pelvic Floor Muscle Training (PFMD) protocol, consisting of three sets throughout the day, with each set including three exercises and ten repetitions of each exercise for a duration of 6 to 8 weeks.
Category
Treatment - Other
3
Description
Intervention group: Mirabegron therapy group: Participants will receive a standard dose of Mirabegron (50 mg) daily."
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Women's Hospital Tabriz - Women's Reproductive Health Research Center
Full name of responsible person
Parvin Bastani
Street address
Al-Zahra Educational and Treatment Center, Baghshamal Intersection, South Army Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138663134
Phone
+98 41 3553 9161
Email
alzahrahospital@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parviz Shahabi
Street address
Tabriz University of Medical Sciences, Central Building No. 2 / Third Floor, Deputy of Research and Technology, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
۹۵۵۷۳۱۴۳۱۶
Phone
+98 41 3335 7311
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Reza Sattarpour
Position
Research assisstant
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Al-Zahra Educational and Treatment Center, Baghshamal Intersection, South Army Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138663134
Phone
+98 41 3553 9161
Email
rezasattarpour.tums@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Reza Sattarpour
Position
Research Assisstant
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Al-Zahra Educational and Treatment Center, Baghshamal Intersection, South Army Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138663134
Phone
+98 41 3553 9161
Email
rezasattarpour.tums@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Reza Sattarpour
Position
Research Assisstant
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Al-Zahra Educational and Treatment Center, Baghshamal Intersection, South Army Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138663134
Phone
+98 41 3553 9161
Email
rezasattarpour.tums@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The published data will include all the measured variables in the study while fully adhering to anonymization principles, presented in an Excel file.
When the data will become available and for how long
Access to the data will begin immediately after the publication and printing of the results.
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Researchers working in academic and scientific institutions have no specific restrictions on data analysis.
From where data/document is obtainable
To obtain study data, correspondence should be made to the following email address: rezasattarpour.tums@gmail.com.
What processes are involved for a request to access data/document
If there is a request for study data, the requester should send a proposal or details of their project via email to the responsible person. If the other researchers agree, the requested data will be provided within a maximum of two months.