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

NCT ID: NCT04500860

Last Updated: 2022-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-01

Study Completion Date

2022-07-01

Brief Summary

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

Detailed Description

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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

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A Tadalafil 5 mg

30 patients subjected to Daily dose of tadalafil 5mg

Group Type ACTIVE_COMPARATOR

Low dose tadalafil 5 mg

Intervention Type DRUG

Efficacy of daily low dose tadalafil 5mg for treatment of female overactive bladder syndrome or urgency with or without urgency urinary incontinence

Group B Tolterodine

30 patients subjected to tolterodine 4 mg daily

Group Type ACTIVE_COMPARATOR

Tolterodine 4 Mg Oral Capsule, Extended Release

Intervention Type DRUG

To compare efficacy of low dose tadalafil 5 mg to tolterodine 4 mg extended release in treatment of female overactive bladder

Group C placebo

30 patients subjected to placebo daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo drugs

Interventions

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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

Intervention Type DRUG

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

Intervention Type DRUG

Placebo

Placebo drugs

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Kasr El Aini Hospital

OTHER

Sponsor Role lead

Responsible Party

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Samer Morsy

Urology lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Samer Morsy

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Cairo University

Identifier Type: -

Identifier Source: org_study_id

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