High-Dose Vitamin D Supplementation and Solifenacin in Overactive Bladder (OAB)

Efficacy and Safety of High-Dose Vitamin D Supplementation and Solifenacin vs Solifenacin alone in Overactive Bladder

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20240504061648N2

Enrollment

100

Registered

2025-03-10

Start date

2025-04-03

Completion date

Unknown

Last updated

2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overactive bladder. Other specified disorders of bladder

Interventions

Intervention 1: Intervention group: They will receive solifenacin 5 mg daily, produced by Tasnim Pharmaceutical Company, and high-dose vitamin D (50,000 units weekly) produced by Tasnim Pharmaceutical

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: OAB symptoms for at least 12 weeks (including urgency, frequency of urination [8 times a day and 2 times at night]) No other anticholinergic medications for 14 days Consent to participate in the study

Exclusion criteria

Exclusion criteria: Clinically significant dysuria Stress urinary incontinence Clinical evidence of urinary tract infection or chronic inflammation within the past 2 weeks (e.g., interstitial cystitis) Patients with bladder stones History of pelvic radiotherapy or previous history of pelvic malignancy Uncontrolled narrow-angle glaucoma Urinary/gastric retention; intestinal obstruction Prescription of diuretics or drugs with cholinergic or anticholinergic side effects Confirmed or suspected allergy to solifenacin, other anticholinergic drugs

Design outcomes

Primary

Measure	Time frame
Urinary incontinence. Timepoint: Initially, 4 weeks and 12 weeks after the start of the intervention. Method of measurement: ICIQ-OAB questionnaire.;Urinary frequency. Timepoint: Initially, 4 weeks and 12 weeks after the start of the intervention. Method of measurement: ICIQ-OAB questionnaire.	—

Secondary

Measure	Time frame
Urinary urgency. Timepoint: Initially, 4 weeks and 12 weeks after the start of the intervention. Method of measurement: ICIQ-OAB questionnaire and bladder diary.;Nocturia. Timepoint: Initially, 4 weeks and 12 weeks after the start of the intervention. Method of measurement: ICIQ-OAB questionnaire and bladder diary.;Residual urine volume. Timepoint: Initially, 4 weeks and 12 weeks after the start of the intervention. Method of measurement: Uroflowmetry.	—

Measure

Time frame

Urinary urgency. Timepoint: Initially, 4 weeks and 12 weeks after the start of the intervention. Method of measurement: ICIQ-OAB questionnaire and bladder diary.;Nocturia. Timepoint: Initially, 4 weeks and 12 weeks after the start of the intervention. Method of measurement: ICIQ-OAB questionnaire and bladder diary.;Residual urine volume. Timepoint: Initially, 4 weeks and 12 weeks after the start of the intervention. Method of measurement: Uroflowmetry.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactSakineh Hajebrahimi

Tabriz University of Medical Sciences

ebrahimis@tbzmed.ac.ir+98 41 3334 2219

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026