Overactive BladderPhase 3NCT07429734
Efficacy of Gabapentin Combined With Solifenacin for Non-neurogenic Overactive Bladder in Women
A Phase 3 study testing solifenacin combined with gabapentin and solifenacin monotherapy in people with Overactive Bladder, run by Mansoura University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- solifenacin combined with gabapentin and solifenacin monotherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2026to Jan 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Overactive bladder symptom score (OABSS) > 5, urgency subscore ≥3, and urge incontinence score≥ 2.
Who cannot join
- Active urinary tract infection
- Neurogenic bladder
- History of genitourinary malignancy
- Stress urinary incontinence (SUI) as primary diagnosis, or mixed urinary incontinence with predominant SUI
- Any psychological or psychiatric disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mohamed Hegazy, Lecturer contact
Egypt1 site
Urology and Nephrology center - Mansoura University
Al Mansurah
Urology and Nephrology center - Mansoura University, +20502202222, unc@mans.edu.eg
About this study
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
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 ?
Read the 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.
- Conditions
- Overactive Bladder
- Being tested
- solifenacin combined with gabapentin, solifenacin monotherapy
- Keywords
- overactive bladder, non-neurogenic, gabapentin, solifenacin, anticholinergic, Randomized Controlled Trial
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
solifenacin combined with gabapentinDrug
using solifenacin combined with gabapentin for treatment of non-neurogenic overactive bladder in women
solifenacin monotherapyDrug
solifenacin monotherapy for treatment of non-neurogenic overactive bladder in women
| Study group | Role | What they receive |
|---|---|---|
| Solifenacin Combined with Gabapentin | Experimental | using solifenacin combined with gabapentin for treatment of non-neurogenic overactive bladder in women Receives: Drug: solifenacin combined with gabapentin |
| solifenacin monotherapy | Sham comparator | solifenacin monotherapy for treatment of non-neurogenic overactive bladder in women Receives: Drug: solifenacin monotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the total score and sub-scores of Overactive Bladder Symptom Score at follow-up visits.
the study will assess the change in total score of overactive bladder symptom score (0-15) before and after recieving the treatment, as the minimum value (0) means better outcome, and maximum value (15) means worse outcome, also it will assess the change in the sub-scores such as : frequency : (0-2) , nocturia : (0-3) , urgency : (0-5) , urge incontinence : (0-5) where minimum values mean better outcome, and maximum values mean worse outcome.
Measured: 90 days
Secondary outcomes (1)
Number of participants with treatment-related adverse events
each patient will be followed up every 6 weeks during the 3 months period and surveyed for side effects. The number of patients who experienced side effects will be compared between the two groups and compare the number of patients who subsequently discontinued the treatment.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study startFeb 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Hegazy, Mansoura University
- Investigators
- Urology and Nephrology center - Mansoura University, Principal investigator, urology and nephrology center mansoura university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07429734
- Sponsor's protocol ID
- MS.25.11.3380
- Status last verified
- Feb 2026
- First submitted
- 13 Feb 2026
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07429734
- Acronym / sponsor ID
- MS.25.11.3380
- Conditions
- Overactive Bladder
- Keywords
- overactive bladder, non-neurogenic, gabapentin, solifenacin, anticholinergic, Randomized Controlled Trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 ?
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Solifenacin Combined with Gabapentin | Experimental | Drug: solifenacin combined with gabapentinusing solifenacin combined with gabapentin for treatment of non-neurogenic overactive bladder in women |
| solifenacin monotherapy | Sham comparator | Drug: solifenacin monotherapysolifenacin monotherapy for treatment of non-neurogenic overactive bladder in women |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Overactive bladder symptom score (OABSS) > 5, urgency subscore ≥3, and urge incontinence score≥ 2.
Key exclusion criteria (5 listed)
- Active urinary tract infection
- Neurogenic bladder
- History of genitourinary malignancy
- Stress urinary incontinence (SUI) as primary diagnosis, or mixed urinary incontinence with predominant SUI
- Any psychological or psychiatric disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| solifenacin combined with gabapentinusing solifenacin combined with gabapentin for treatment of non-neurogenic overactive bladder in women | Drug | Solifenacin Combined with Gabapentin |
| solifenacin monotherapysolifenacin monotherapy for treatment of non-neurogenic overactive bladder in women | Drug | solifenacin monotherapy |
Primary outcome
Change from baseline in the total score and sub-scores of Overactive Bladder Symptom Score at follow-up visits.
Time frame: 90 days
the study will assess the change in total score of overactive bladder symptom score (0-15) before and after recieving the treatment, as the minimum value (0) means better outcome, and maximum value (15) means worse outcome, also it will assess the change in the sub-scores such as : frequency : (0-2) , nocturia : (0-3) , urgency : (0-5) , urge incontinence : (0-5) where minimum values mean better outcome, and maximum values mean worse outcome.
1 secondary outcome
Number of participants with treatment-related adverse events
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohamed Hegazy, Lecturer contact
Urology and Nephrology center - Mansoura University principal investigator
urology and nephrology center mansoura university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing solifenacin combined with gabapentin and solifenacin monotherapy in people with Overactive Bladder, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Elmaghawry, Resident (+201125334957, m7md.gano2016@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the total score and sub-scores of Overactive Bladder Symptom Score at follow-up visits. (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.