Efficacy of Gabapentin Combined With Solifenacin for Non-neurogenic Overactive Bladder in Women

February 23, 2026 updated by: Mohammed Hegazy, Mansoura University

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 ?

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Al Mansurah, Egypt
        • Urology and Nephrology center - Mansoura University
        • Contact:
          • Urology and Nephrology center - Mansoura University
          • Phone Number: +20502202222
          • Email: unc@mans.edu.eg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Overactive bladder symptom score (OABSS) > 5, urgency subscore ≥3, and urge incontinence score≥ 2.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Solifenacin Combined with Gabapentin
using solifenacin combined with gabapentin for treatment of non-neurogenic overactive bladder in women
Drug: solifenacin combined with gabapentin
using solifenacin combined with gabapentin for treatment of non-neurogenic overactive bladder in women
Sham Comparator: solifenacin monotherapy
solifenacin monotherapy for treatment of non-neurogenic overactive bladder in women
Drug: solifenacin monotherapy
solifenacin monotherapy for treatment of non-neurogenic overactive bladder in women

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with treatment-related adverse events
Time Frame: 90 days
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.
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Principal Investigator: Urology and Nephrology center - Mansoura University, Urology and Nephrology center - Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

February 13, 2026

First Submitted That Met QC Criteria

February 23, 2026

First Posted (Actual)

February 24, 2026

Study Record Updates

Last Update Posted (Actual)

February 24, 2026

Last Update Submitted That Met QC Criteria

February 23, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS.25.11.3380

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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