Clinical trial NCT06024005: Comparison of the Transcutaneous Tibial Nerve Stimulation and Drug Treatment' Effects in Women With Overactive Bladder
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overactive Bladder
Overactive Bladder Syndrome
Keywords: Overactive Bladder
Transcutaneous Electric Nerve Stimulation
Neuromodulation
Urge Urinary Incontinence
Quality of Life
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2023-09-05
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Total Daily Incontinence Episodes
timeFrame: 6 weeks
measure: Evaluation of Quality of Life
timeFrame: 6 weeks
Secondary outcomes:
measure: Symptom Assessment
timeFrame: 6 weeks
measure: Symptom Assessment
timeFrame: 6 weeks
measure: Symptom Assessment
timeFrame: 6 weeks
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege University, School of Medicine, Department of Obstetrics and Gynecology
Study officials:
affiliation: Ege University School of Medicine, Department of Obstetrics and Gynecology,
name: Ahmet Ozgur OY Yeniel
role: PRINCIPAL_INVESTIGATOR
References: