Low Dose Tadalafil for Treatment of Female OAB Syndrome: Short Term Follow up.

Kasr El Aini Hospital

Status and phase: Completed; Phase 1

Conditions: Female Patients With Overactive Bladder Syndrome or Female Patients With Urgency or Urgency Urinary Incontinence

Treatments: Drug: Low dose tadalafil 5 mg; Drug: Placebo; Drug: Tolterodine 4 Mg Oral Capsule, Extended Release

Study type: Interventional

Funder types: Other

Identifiers

NCT04500860

Cairo University

Details and patient eligibility

About

Evaluation of use of low dose tadalafil 5 mg daily for treatment of female OAB syndrome

Full description

90 female patients with overactive bladder syndrome divided into 3 groups group A subjected to daily low dose tadalafil 5 mg ,group B subjected to tolterodine and group C to placebo. They are evaluated as using OAB symptoms score for 6 months follow up

Enrollment: 90 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• any female with overactive bladder syndrome, urgency with or without urgency urinary incontinence

Exclusion criteria

• Active Urinary tract infection
• neurologic abnormality
• Pure Stress urinary incontinence

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups, including a placebo group

Group A Tadalafil 5 mg

Active Comparator group

Description:

30 patients subjected to Daily dose of tadalafil 5mg

Treatment:

Drug: Low dose tadalafil 5 mg

Group B Tolterodine

Active Comparator group

Description:

30 patients subjected to tolterodine 4 mg daily

Treatment:

Drug: Tolterodine 4 Mg Oral Capsule, Extended Release

Group C placebo

Placebo Comparator group

Description:

30 patients subjected to placebo daily

Treatment:

Drug: Placebo