1. What data in particular will be shared?
   Response - All of the individual participant data collected during the trial, after de-identification.
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   
   
3. Who will be able to view these files?
   Response - Anyone
   


4. For what types of analyses will this data be available?
   Response - To achieve aims in the approved proposal.
   


5. By what mechanism will data be made available?
   Response (Others) -  Data will be available on request to primary investigator.


6. For how long will this data be available start date provided 01-01-2026 and end date provided 31-12-2030?
   Response - Beginning 3 months and ending 5 years following article publication.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

Background

In the traditional management of OAB TTNS, currently the physical therapists are using only TENS currents. However, TENS is very commonly replaced by diadynamic currents in the literature for various musculoskeletal pain syndromes. However, there is no literature available with regard to the usage of diadynamic currents for the TTNS procedure.

Aim of the study

Analyzing the Efficacy of Diadynamic Currents (DDC) versus Transcutaneous Electrical Nerve Stimulation (TENS) for Transcutaneous Tibial Nerve Stimulation (TTNS) in Overactive Bladder (OAB) Treatment.

Objectives of the study

1. To find out the effect of TENS usage in TTNS along with conventional physical therapy (CPT) in improving impairments, activity and quality of life among subjects with OAB
2. To find out the effect of DDC usage in TTNS along with conventional physical therapy (CPT) in improving impairments, activity and quality of life among subjects with OAB
3. To compare the effect of TENS versus DDC usage in TTNS along with conventional physical therapy (CPT) in improving impairments, activity and quality of life among subjects with OAB
4. To find out the correlation between patient-related factors like age, height, weight, BMI, duration of disease, predisposing disorders with impairments, activity and quality of life among subjects with OAB

Significance of the study

1. Demonstrating the efficacy of DDC usage in TTNS along with conventional physical therapy (CPT) in improving impairments, activity and quality of life among subjects with OAB
2. Providing the alternative treatment availability for subjects with OAB
3. Enhancing the patients’ quality of life by using electrical stimulation as an adjunct treatment for subjects with OAB

Methodology

This quasi-randomized controlled trial is conducted in accordance with Halinski’s ethical principles. The study obtained ethical committee approval from the Krishna Institute of Medical Sciences, with approval number KIMS/EC/BMHR/2024/95-01. The sample was collected using convenience sampling, and participants were distributed into two groups alternately as they were referred to our department. Subjects of the study were people suffering from overactive bladder disorder (OABD), and the population included in our study was adult females. The subjects of OABD who had undergone any surgical procedure for the same problem, had metal implants in the tibia and foot, lack of sensation in the foot, or had any other bladder disorder were excluded from the study process.

The sample size for the study was calculated by using the clincalc.com sample size calculation. (15) In this quasi-experimental study design, the experimental and control groups receive different treatments. The anticipated mean values required for calculating sample size were taken from the literature, where TTNS was used as the experimental treatment and ICIQ-OAB as the outcome measure. (16) Based on this study, we set the power at 80%, the probability of type 1 error (alpha) at 0.05, the probability of type 2 error (beta) at 0.2, and the enrollment ratio between the groups at 1. The expected sample size was 27 per group, including a 10% dropout rate; we expected a sample size of 30 per group, and across the two groups, we recruited 60 members in total.

The study is conducted in the Rehabilitation Department of Krishna Institute of Medical Sciences, Minister Road Branch, Hyderabad, India. The principal investigator and secondary investigators have more than 10 years of experience in physical therapy and are experts in women’s health cases. The study was conducted for 1 year, from December 2024 to November 2025. The materials required for the study included the Combined Electrotherapy Unit from Enraf Nonius, self-adhesive disposable electrodes of 5X5 size, a couch, a chair, a table, and some office materials.

The outcome measures used for the study are the International Consultation on Incontinence Questionnaire for Overactive Bladder (ICIQ-OAB) and the International Consultation on Incontinence Questionnaire for Overactive Bladder Quality of Life (ICIQ-OAB qol). (17-19)

The International Consultation on Incontinence Questionnaire for Overactive Bladder (ICIQ-OAB) is a valid and reliable patient-reported scale used to assess the severity and impact of overactive bladder on subjects. This scale has four items: daytime urinary frequency, nighttime urinary frequency, urgency, and urinary incontinence. Each item is scored for symptom severity and the extent to which this clinical feature bothers the patient. The symptom severity is scored on a maximum of four points; hence, four items together will make a minimum to maximum score of zero to 16, and the higher the score, the more severe the symptom severity. Each item is scored on a 0-10 scale, but this is not included in the total severity score; however, it provides deeper insight into patients’ feelings, which can be used to plan treatment. (20)

The International Consultation on Incontinence Questionnaire for Overactive Bladder Quality of Life (ICIQ-OAB qol) is a patient-reported questionnaire used to measure health-related quality of life among subjects with overactive bladder syndrome. The scale comprises 26 items, grouped into domains such as emotions, psychological impact, daily activities, lifestyle limitations, sleep, energy levels, relationships, and general quality of life. The 1st 25 items are measured on a scale of one to six. Where one indicated less impact, six indicated a high impact of the OAB on their life. In contrast, the last item is measured on a 0-to-10-point scale that denotes the overall quality of life affected by OAB. The total score of this scale ranges from 25 to 160, with higher scores indicating greater OAB impact on their lives and lower scores indicating less impact. (21)

The study sample was selected from referrals to our department from the urogynecology department. The subjects were informed about the study, and written informed consent was obtained. No force was used on the subjects, and their information was kept confidential throughout. All participants were adult women who could read and understand the questionnaire in English; the therapist provided any clarifications needed. The subjects were divided into the control group using TTNS by Transcutaneous Electrical Nerve Stimulation (TENS) in conjunction with the conventional physical therapy (CPT) and the experimental group using TTNS by Dia Dynamic (DD) currents in conjunction with the CPT.

The subjects were informed in detail about the treatment procedure before undergoing it. Once the subject is in a comfortable position, we will collect the materials required for the stimulation procedure, such as the machine, electrodes, sanitizer, and cotton. The TTNS procedure was performed in the supine position, and the area of stimulation was tested for touch and temperature sensations using a brush and test tubes. The subjects were instructed that they would feel a mild tingling sensation from the electrical current, which is not painful, and that they should inform the therapist if they experienced any abnormal sensations, such as heat, burning, pain, or spasm. The stimulation area was cleaned with sanitizer and cotton. Once the area was dry, the self-adhesive electrodes were secured to the leg. The anode was kept on the medial arch of the foot, and the cathode was kept 10 cm above the medial malleolus superiorly and posteriorly on the same foot. (22, 23) The left or right foot is chosen based on the subject’s preference and the therapist’s convenience.

Intervention in the control group was TTNS with Transcutaneous Electrical Nerve Stimulation (TENS) in conjunction with the CPT. Transcutaneous electrical nerve stimulation is continuous stimulation at a pulse width of 200 microseconds and a frequency of 10 Hz. The amplitude was set to produce a sensory stimulus in the ipsilateral foot, at an intensity tolerable to the patient; the commonly used range was 30 to 70 mA. (24) Usually we increased the intensity gradually and tried to reach a level at which we elicited a motor response of great toe extension. The therapy consists of 30 minutes of TENS and 30 minutes of CPT, two sessions per week for four weeks, for a total of 8 sessions.

Intervention in the experimental group was TTNS with DD currents in conjunction with the CPT. DD current stimulation was performed at 10 Hz, with a pulse width of 200 microseconds and an intensity usually between 30 and 70 milliamperes, based on the subject’s comfort. Commonly, we increased the intensity gradually and tried to reach a level at which we elicited a motor response of great toe extension. The therapy consists of 30 minutes of DD currents and 30 minutes of CPT, two sessions per week for four weeks, for a total of 8 sessions.

Intervention in the conventional physical therapy includes Kegel exercises and breathing exercises. The subjects will perform Kegel exercises for 15 minutes and breathing exercises for another 15 minutes, two sessions per week for four weeks, completing eight sessions in total in front of the therapist. The home program included Kegel exercises: 10 repetitions, with a 5-second hold, three times a day, along with deep breathing exercises.

In both groups, the therapy lasted 60 minutes by the therapist for a total of 8 sessions in a period of four weeks. Both the groups also had the same home program of Kegels and deep breathing exercises. The outcome measures were collected pre- and post-intervention for 4 weeks.