NCT07429734

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 ?

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
7mo left

Started Feb 2026

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress33%
Feb 2026Jan 2027

Study Start

First participant enrolled

February 1, 2026

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

February 13, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 24, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

February 24, 2026

Status Verified

February 1, 2026

Enrollment Period

8 months

First QC Date

February 13, 2026

Last Update Submit

February 23, 2026

Conditions

Overactive Bladder

Keywords

overactive bladdernon-neurogenicgabapentinsolifenacinanticholinergicRandomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

  • 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.

    90 days

Secondary Outcomes (1)

  • Number of participants with treatment-related adverse events

    90 days

Study Arms (2)

Solifenacin Combined with Gabapentin

EXPERIMENTAL

using solifenacin combined with gabapentin for treatment of non-neurogenic overactive bladder in women

Drug: solifenacin combined with gabapentin

solifenacin monotherapy

SHAM COMPARATOR

solifenacin monotherapy for treatment of non-neurogenic overactive bladder in women

Drug: solifenacin monotherapy

Interventions

solifenacin combined with gabapentinDRUG

using solifenacin combined with gabapentin for treatment of non-neurogenic overactive bladder in women

Solifenacin Combined with Gabapentin
solifenacin monotherapyDRUG

solifenacin monotherapy for treatment of non-neurogenic overactive bladder in women

solifenacin monotherapy

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology and Nephrology center - Mansoura University

Al Mansurah, Egypt

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AminesOrganic Chemicalsgamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsCyclohexanecarboxylic AcidsAcids, CarbocyclicCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Urology and Nephrology center - Mansoura University

    Urology and Nephrology center - Mansoura University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Elmaghawry, Resident

CONTACT

+201125334957m7md.gano2016@gmail.com

Mohamed Hegazy, Lecturer

CONTACT

hegazym912@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of urology

Study Record Dates

First Submitted

February 13, 2026

First Posted

February 24, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

February 24, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations

EG(1)