Clinical trial

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

Name
TTNS for OAB
Description
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.
Trial arms
Trial start
2023-04-18
Estimated PCD
2023-05-24
Trial end
2023-05-24
Status
Completed
Treatment
Oral Solifenacin 5mg
Oral solifenacin (Kinzy 5mg) use once a day for 6 weeks
Arms:
Drug Group
Other names:
Kinzy 5mg
Transcutaneous Posterior Tibial Nerve Stimulation (TTNS)
Application of TTNS twice a week for 6 weeks, with each session for 30 minutes
Arms:
Device Group
Other names:
Urostim 2
Size
34
Primary endpoint
Number of Total Daily Incontinence Episodes
6 weeks
Evaluation of Quality of Life
6 weeks
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 34, 'type': 'ACTUAL'}}
Updated at
2023-09-05

1 organization

1 product

2 indications

Organization
Ege University