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

Female Patients With Overactive Bladder Syndrome or Female Patients With Urgency or Urgency Urinary Incontinence Clinical Trial

Official title:

Low Dose Tadalafil 5mg for Treatment of Female Overactive Bladder Syndrome :6 Months Follow up

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04500860
• Other study ID #: Cairo University
• Status: Completed
• Phase: Phase 1
• Start date: December 1, 2020
• Est. completion date: July 1, 2022

Study information

• Verified date: August 2022
• Source: Kasr El Aini Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Female Patients With Overactive Bladder Syndrome or Female Patients With Urgency or Urgency Urinary Incontinence
• Syndrome
• Urinary Bladder, Overactive
• Urinary Incontinence

Intervention

Drug:
• Low dose tadalafil 5 mg
Efficacy of daily low dose tadalafil 5mg for treatment of female overactive bladder syndrome or urgency with or without urgency urinary incontinence
• Tolterodine 4 Mg Oral Capsule, Extended Release
To compare efficacy of low dose tadalafil 5 mg to tolterodine 4 mg extended release in treatment of female overactive bladder
• Placebo
Placebo drugs

Locations

Country	Name	City	State
Egypt	Samer Morsy	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of daily low dose tadalafil 5mg in treatment of female overactive bladder syndrome: 6 months follow up	Evaluation of efficacy of tadalafil 5 mg	6 months