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

NCT ID: NCT06024005

Last Updated: 2023-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-18
• Study Completion Date: 2023-05-24

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.

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.

Conditions

Overactive Bladder; Overactive Bladder Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Device Group

Transcutaneous device group with Urostim 2

Group Type: ACTIVE_COMPARATOR

Transcutaneous Posterior Tibial Nerve Stimulation (TTNS)

Intervention Type: DEVICE

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

Drug Group

Drug Group with Kinzy 5 mg

Group Type: ACTIVE_COMPARATOR

Oral Solifenacin 5mg

Intervention Type: DRUG

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

Interventions

Oral Solifenacin 5mg

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

Intervention Type: DRUG

Transcutaneous Posterior Tibial Nerve Stimulation (TTNS)

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

Intervention Type: DEVICE

Other Intervention Names

Kinzy 5mg; Urostim 2

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ege University

OTHER

Sponsor Role: lead

Responsible Party

Ahmet Ozgur Yeniel

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmet Ozgur OY Yeniel

Role: PRINCIPAL_INVESTIGATOR

Ege University School of Medicine, Department of Obstetrics and Gynecology,

Locations

Ege University, School of Medicine, Department of Obstetrics and Gynecology

Izmir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

TTNS for OAB

Identifier Type: -

Identifier Source: org_study_id