Comparison of the Transcutaneous Tibial Nerve Stimulation and Drug Treatment' Effects in Women With Overactive Bladder
Condition: Overactive Bladder; Overactive Bladder Syndrome
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional

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.
    

Intervention name(s): Oral Solifenacin 5mg; Transcutaneous Posterior Tibial Nerve Stimulation (TTNS)
Intervention type(s): Drug; Device
Intervention description(s): Oral solifenacin (Kinzy 5mg) use once a day for 6 weeks; Application of TTNS twice a week for 6 weeks, with each session for 30 minutes
Other intervention name(s): Kinzy 5mg; Urostim 2
Intervention MeSH terms: Solifenacin Succinate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Overactive Bladder; Transcutaneous Electric Nerve Stimulation; Neuromodulation; Urge Urinary Incontinence; Quality of Life