Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-04-05 @ 8:50 AM
Study NCT ID:
NCT07429734
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-24
First Post:
2026-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Gabapentin Combined With Solifenacin for Non-neurogenic Overactive Bladder in Women
Sponsor:
Mansoura University
Organization:
Study Overview
Official Title:
Efficacy and Tolerability of Solifenacin Combined With Gabapentin Versus Solifenacin Monotherapy for the Treatment of Non-neurogenic Overactive Bladder in Women: A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
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:
The goal of the study is to compare the efficacy, safety and tolerability of solifenacin plus gabapentin versus solifenacin monotherapy for the treatment of women who are suffering from non-neurogenic ОАВ.
The main questions it aims to answer are:
Does combination of Solifenacin and Gabapentin affect the total score and sub-scores of OABSS in females with non-neurogenic ОАВ ? What medical problems do participants have when taking combination of Solifenacin and gabapentin ?
The main questions it aims to answer are:
Does combination of Solifenacin and Gabapentin affect the total score and sub-scores of OABSS in females with non-neurogenic ОАВ ? What medical problems do participants have when taking combination of Solifenacin and gabapentin ?
Detailed Description:
Overactive bladder (OAB) syndrome is defined as a pathological condition characterized by urinary urgency, with or without incontinence, urinary frequency and nocturia in the absence of infection or other identifiable pathology. Global prevalence among women is estimated to be 21.9% with even higher prevalence among Egyptian women suggested to be around 57%. The pathophysiology of overactive bladder is incompletely understood. The underlying mechanism behind OAB symptoms is often detrusor overactivity (DOA), which has been linked to bladder ischemia and oxidative stress. Also, it is believed to be related to dysfunction within the nervous system, ranging from cortical and brainstem command centers to afferent signaling at the urothelial level. Also it is may be related to spontaneous activity in the detrusor muscle which can lead to involuntary contractions and urgency sensations, even without abnormal nerve stimulation. Antimuscarinic agents, such as solifenacin, are considered first-line pharmacological therapy after failure of conservative measures. However, the efficacy as a monotherapy is limited, and many patients experience persistent symptoms. Therefore, combination therapy using antimuscarinics and other agents such as B3 agonists has been proven to have more efficacy compared to monotheraрy.
Currently the focus of OAB treatment has changed to other bladder structures and mechanisms, such as modulation of bladder afferent outflow and urothelial signaling as targets for intervention. Gabapentin, a neuromodulator commonly used for neuropathic pain, has shown potential benefits in bladder hypersensitivity and sensory urgency due to its inhibitory effect on afferent C fiber activity, as these fibers demonstrate remarkable plasticity, which is involved in the micturition reflex to the spinal tract. Several randomized controlled trials and cohort studies have demonstrated some improvement in OAB symptoms with minimal adverse effects following gabapentin administration, supporting its potential use as a treatment for OAB. However, the vast majority of studies are done in neurogenic bladder, had relatively small sample sizes and modest treatment effects, and only very few studies are done in non-neurogenic bladders.
In this study, it is assumed that combination therapy of solifenacin and gabapentin may provide synergistic effects, improving both detrusor overactivity and sensory urgency, leading to better patient outcomes than solifenacin monotherapy.
Currently the focus of OAB treatment has changed to other bladder structures and mechanisms, such as modulation of bladder afferent outflow and urothelial signaling as targets for intervention. Gabapentin, a neuromodulator commonly used for neuropathic pain, has shown potential benefits in bladder hypersensitivity and sensory urgency due to its inhibitory effect on afferent C fiber activity, as these fibers demonstrate remarkable plasticity, which is involved in the micturition reflex to the spinal tract. Several randomized controlled trials and cohort studies have demonstrated some improvement in OAB symptoms with minimal adverse effects following gabapentin administration, supporting its potential use as a treatment for OAB. However, the vast majority of studies are done in neurogenic bladder, had relatively small sample sizes and modest treatment effects, and only very few studies are done in non-neurogenic bladders.
In this study, it is assumed that combination therapy of solifenacin and gabapentin may provide synergistic effects, improving both detrusor overactivity and sensory urgency, leading to better patient outcomes than solifenacin monotherapy.
Study Oversight
Has Oversight DMC:
False
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?:
True
Is an FDA AA801 Violation?: