Iranian 4mg slow-release tolterodine capsule and overactive bladder syndrome

Comparing the efficacy of tolterodine 4 mg extended-released capsule produced by Tadbir Kalaye Jam pharmaceutical company (Detrolit) with extended-released Detrusitol 4 mg capsule of Pfizer company on overactive bladder (OAB) syndrome, a double blind randomized clinical trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20231002059589N1

Enrollment

100

Registered

2025-03-16

Start date

2025-04-21

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 (OAB) syndrome. Overactive Bladder Syndrome

Interventions

Intervention 1: Intervention group: The group that was randomly assigned after the diagnosis of overactive bladder for the first time by a urologist will be prescribed one 4 mg slow-release tolterodin

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Age 18 to 65 Having overactive bladder disease Filling out the consent form Absence of relative and absolute contraindications to drug use

Exclusion criteria

Exclusion criteria: Willingness to participate in a similar study at the same time Use of anticholinergic drugs or beta-3 agonists that affect the urinary system

Design outcomes

Primary

Measure	Time frame
Overactive Bladder Syndrome Scale. Timepoint: At the beginning of the study (before the start of the intervention) and 7, 14, and 21 days after the start of the drug in both the intervention and control groups. Method of measurement: At the beginning of the study (before medication is administered) and every week, the OABSS (Overactive Bladder Symptom Scale) tool will be completed by telephone by a trained person for each patient.	—

Measure

Time frame

Overactive Bladder Syndrome Scale. Timepoint: At the beginning of the study (before the start of the intervention) and 7, 14, and 21 days after the start of the drug in both the intervention and control groups. Method of measurement: At the beginning of the study (before medication is administered) and every week, the OABSS (Overactive Bladder Symptom Scale) tool will be completed by telephone by a trained person for each patient.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaryam Emami

Iran University of Medical Sciences

emami59658@yahoo.com+98 21 81161

Outcome results

None listed

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