Ignite Creation Date:
2024-05-06 @ 7:28 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06024005
Status:
COMPLETED
Last Update Posted:
2023-09-05
First Post:
2023-07-02
Brief Title:
Comparison of the Transcutaneous Tibial Nerve Stimulation and Drug Treatment Effects in Women With Overactive Bladder
Sponsor:
Ege University
Organization:
Ege University
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 200
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 200
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None