Health TrialsbyHealthPanel

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

ConditionOveractive Bladder
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMansoura University

About this 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 ?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Active urinary tract infection

Neurogenic bladder

History of genitourinary malignancy

Stress urinary incontinence (SUI) as primary diagnosis, or mixed urinary incontinence with predominant SUI

Trial design

Design model

Parallel

Treatments tested in this trial

  • solifenacin combined with gabapentin

    Drug

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

  • solifenacin monotherapy

    Drug

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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Solifenacin Combined with GabapentinExperimental treatment 1 intervention
Group B: solifenacin monotherapySham comparator 1 intervention

Trial outcomes

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.

Time frame
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.

Time frame
90 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mansoura University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: