An interventional study of Oral Solifenacin 5mg and Transcutaneous Posterior Tibial Nerve Stimulation (TTNS) in Overactive Bladder and Overactive Bladder Syndrome, sponsored by Ege University. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-09-05.
Sponsored by Ege University · Not applicable, Interventional, and Treatment
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.
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.
855 studies on the registry are indexed under Urinary Bladder, Overactive; 125 are open to participants now.
This study's enrollment of 34 is below the median of 72 across 652 interventional studies indexed under Urinary Bladder, Overactive.
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Exclusion Criteria:
Transcutaneous device group with Urostim 2
Device: Transcutaneous Posterior Tibial Nerve Stimulation (TTNS)
Drug Group with Kinzy 5 mg
Drug: Oral Solifenacin 5mg
Oral solifenacin (Kinzy 5mg) use once a day for 6 weeks
Also known as: Kinzy 5mg
Application of TTNS twice a week for 6 weeks, with each session for 30 minutes
Also known as: Urostim 2
Number of Total Daily Incontinence Episodes
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.
Time frame: 6 weeks
Evaluation of Quality of Life
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.
Time frame: 6 weeks
Symptom Assessment
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.
Time frame: 6 weeks
Symptom Assessment
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.
Time frame: 6 weeks
Symptom Assessment
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.
Time frame: 6 weeks
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Ege University