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OpenTrials
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NCT Number: NCT07312955

Solifenacin Plus Tadalafil vs Solifenacin Alone for Overactive Bladder in Females

Overactive bladder (OAB) is characterized by urinary urgency with or without urge urinary incontinence, usually with frequency and nocturia, in the absence of urinary tract infection or other obvious pathology. Antimuscarinic agents such as solifenacin are commonly used but may provide incomplete symptom control. Tadalafil (a Phosphodiesterase type 5 inhibitorsinhibitor) has been reported to improve lower urinary tract symptoms and may offer additional benefit in overactive bladder. This randomized controlled trial evaluates the efficacy and tolerability of solifenacin 5 mg plus tadalafil 5 mg versus solifenacin 5 mg alone in females with overactive bladder using the Overactive Bladder Symptom Score (OABSS).

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Key information

Conditions

Overactive Bladder Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Nocturia Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urinary Incontinence Urinary Incontinence, Urge Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University Hospital (Urology Department)

Cairo, Cairo Governorate, 11511, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female patients aged 18 to 60 years.
  • Symptoms of overactive bladder for more than 6 months.
  • Not receiving current medical treatment for overactive bladder.
  • Normal liver function tests.
  • Normal kidney function.

Exclusion criteria

  • Congestive heart failure or history of recent cardiovascular events.
  • Currently on medical treatment for overactive bladder.
  • Urinary tract infection (eligible only after treatment and resolution).
  • Urinary bladder stones.
  • Post-void residual urine > 100 cubic centimeter (cm³).
  • Closed-angle glaucoma or recent ocular problems.
  • Postural hypotension.
  • History of neurological disorders (e.g., parkinsonism).
  • History of intestinal obstruction.
  • Pregnancy or planning pregnancy.
  • Myasthenia gravis.
  • Severe hepatic impairment.
  • History of hypersensitivity to solifenacin or tadalafil.

Treatment and study plan

solifenacin

Drug

Solifenacin 5 mg oral tablet, once daily for 3 months.

Tadalafil

Drug

Tadalafil 5 mg oral tablet, once daily for 3 months.

Primary outcomes

  1. Change in total Overactive Bladder Symptom Score (OABSS) at 1 month

    Time frame: Baseline and 1 month

    Difference in total OABSS (sum of frequency, nocturia, urgency, and urge incontinence domain scores; higher scores indicate worse symptoms) from baseline to 1 month.

Secondary outcomes

  1. Change in total Overactive Bladder Symptom Score (OABSS) at 3 months

    Time frame: Baseline and 3 months

    Difference in total OABSS from baseline to 3 months.

  2. Incidence of adverse effects (tolerability)

    Time frame: Up to 3 months

    Number and percentage of participants reporting adverse effects during the treatment period.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Efficacy of Combination of Solifenacin and Tadalafil Versus Solifenacin Alone in Treatment of Overactive Bladder in Females

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 31, 2025
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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