Comparison of the Transcutaneous Tibial Nerve Stimulation and Drug Treatment' Effects in Women With Overactive Bladder

Sponsor

Ege University (Other)

Overall Status

Completed

CT.gov ID

NCT06024005

Collaborator

(none)

Enrollment

Location

Arms

1.2

Actual Duration (Months)

28.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Overactive bladder (OAB) syndrome is a symptom complex characterized by sudden urgency, frequent urination, nocturia, and urge incontinence without any identifiable organic cause, significantly impacting the quality of life. One of the most prominent symptoms is the urgency to urinate accompanied by a sudden sensation of bladder fullness.

There are various treatment options available for managing OAB, including conservative therapy, pharmacotherapy, and surgical management. High-level evidence supports solifenacin as the standard medical treatment for OAB, offering advantages such as not being affected by food intake, efficacy regardless of gender, and high bioavailability. However, it is known to cause discontinuation of treatment in many cases due to the occurrence of side effects. Posterior tibial nerve stimulation (PTNS) is a neuromodulation technique that has been internationally recognized and proven effective in the treatment of OAB, providing several advantages. It can be applied through two methods: percutaneous (PTNS) and transcutaneous (TTNS). PTNS is an invasive method that requires specialized equipment and a trained healthcare professional, which limits its routine use due to treatment costs.

In the literature, it is stated that in the treatment of OAB, alone or combined PTNS applications are superior to drug monotherapies, but there are limited studies on this subject. Therefore, the study aim was to compare the efficacy, side effects and quality of life of solifenacin and TTNS.

Condition or Disease	Intervention/Treatment	Phase
Overactive Bladder Overactive Bladder Syndrome	Drug: Oral Solifenacin 5mg Device: Transcutaneous Posterior Tibial Nerve Stimulation (TTNS)	N/A

Detailed Description

According to the inclusion and exclusion criteria, 34 female patients with OAB were enrolled in the study. The patients were randomly divided into two groups, with 17 individuals in each group. Patients with odd case numbers were assigned to the Oral Solifenacin group, while those with even case numbers were assigned to the TTNS group.

Prior to treatment, the sociodemographic characteristics, birth history, and past treatment information of all participants were recorded. Basic urogynecological evaluation, pelvic floor ultrasound, and urine culture were performed. To assess symptoms and quality of life, the Overactive Bladder Assessment Form (OAB-V8), Incontinence Quality of Life Scale (I-QQL), Incontinence Impact Questionnaire (IIQ-7), Urogenital Distress Inventory (UDI-6), and a three-day bladder diary were used. After 6 weeks of treatment, all evaluations were repeated. The treatment regimen consisted of once-daily oral solifenacin for the medication group and 2 sessions per week, 30 minutes per session, for 12 sessions using the Urostim-2 device for the TTNS group. The stimulation intensity was increased until a motor or sensory response was obtained, and the threshold value was determined. The entire TTNS procedure was performed under the supervision of an expert physician at the Urogynecology Outpatient Clinic of Ege University Hospital. Statistical analysis was conducted using SPSS 20.0.

Study Design

Study Type:

Interventional

Actual Enrollment :

34 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Prospective Randomized Controlled Trial: Comparison of the Transcutaneous Posterior Tibial Nerve Stimulation and Oral Solifenacin Treatments' Effects in Women Between 18-80 Years Old Who Have Overactive Bladder

Actual Study Start Date :

Apr 18, 2023

Actual Primary Completion Date :

May 24, 2023

Actual Study Completion Date :

May 24, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Device Group Transcutaneous device group with Urostim 2	Device: Transcutaneous Posterior Tibial Nerve Stimulation (TTNS) Application of TTNS twice a week for 6 weeks, with each session for 30 minutes Other Names: Urostim 2
Active Comparator: Drug Group Drug Group with Kinzy 5 mg	Drug: Oral Solifenacin 5mg Oral solifenacin (Kinzy 5mg) use once a day for 6 weeks Other Names: Kinzy 5mg

Arm

Intervention/Treatment

Active Comparator: Device Group

Transcutaneous device group with Urostim 2

Device: Transcutaneous Posterior Tibial Nerve Stimulation (TTNS)

Application of TTNS twice a week for 6 weeks, with each session for 30 minutes

Other Names:

Urostim 2

Active Comparator: Drug Group

Drug Group with Kinzy 5 mg

Drug: Oral Solifenacin 5mg

Oral solifenacin (Kinzy 5mg) use once a day for 6 weeks

Other Names:

Kinzy 5mg

Outcome Measures

Primary Outcome Measures

Number of Total Daily Incontinence Episodes [6 weeks]
It was obtained using a three-day bladder diary. Objective. Meaningful for patients. Correlates with patients' daily activities. It may not be directly related to the severity of urine leakage. Subject to variability. Requires patient compliance. Day and night urine leakages were recorded separately by the patient for three days. The mean total score for a day was calculated.
Evaluation of Quality of Life [6 weeks]
The Incontinence Quality of Life Scale (I-QOL), consisting of 22 questions, was used to analyze the improvement in quality of life. It is a validated questionnaire. Higher scores indicate a better level of quality of life compared to lower scores. It is meaningful for patients. It is standardized. It takes into account the patient's daily activities. Subjective. Subject to variability. Not correlated with the severity of urine leakage.

Secondary Outcome Measures

Symptom Assessment [6 weeks]
Overactive Bladder Assessment Form (OAB-V8), was used for symptomatic evaluation and to assess the impact of symptoms on quality of life. It is a validated questionnaire. A higher score means a worse outcome. Meaningful for patients. It is standardized. The patient's daily activities are taken into account. Subjective. Subject to variability. Not correlated with the severity of urine leakage.
Symptom Assessment [6 weeks]
Urogenital Distress Inventory (UDI-6), was used for symptomatic evaluation and to assess the impact of symptoms on quality of life. It is a validated questionnaire. A lesser score means a better outcome. Meaningful for patients. It is standardized. The patient's daily activities are taken into account. Subjective. Subject to variability. Not correlated with the severity of urine leakage.
Symptom Assessment [6 weeks]
Incontinence Impact Questionnaire (IIQ-7), was used for symptomatic evaluation and to assess the impact of symptoms on quality of life. It is a validated questionnaire. A lesser score means a better outcome. Meaningful for patients. It is standardized. The patient's daily activities are taken into account. Subjective. Subject to variability. Not correlated with the severity of urine leakage.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Female patients with a diagnosis of OAB and unresponsive to first-line treatment,
Absence of genito-urinary system malformations that may cause pollacullaire,
Volunteering to participate in the research,
To be literate in Turkish

Exclusion Criteria:

Having a urinary tract infection,
Having pelvic organ prolapse greater than stage 2,
To be diagnosed with stress type urinary incontinence,
Having narrow-angle glaucoma, myasthenia gravis and severe gastro-intestinal diseases,
Patients undergoing hemodialysis,
Having severe liver or kidney failure,
Pregnancy,
Having a pacemaker
Presence of epilepsy,
The presence of built-in metal in the ankle
Open ankle wound