NCT04500860

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 5, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

August 15, 2022

Status Verified

August 1, 2022

Enrollment Period

1.6 years

First QC Date

August 3, 2020

Last Update Submit

August 11, 2022

Conditions

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

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Group A Tadalafil 5 mg

ACTIVE COMPARATOR

30 patients subjected to Daily dose of tadalafil 5mg

Drug: Low dose tadalafil 5 mg

Group B Tolterodine

ACTIVE COMPARATOR

30 patients subjected to tolterodine 4 mg daily

Drug: Tolterodine 4 Mg Oral Capsule, Extended Release

Group C placebo

PLACEBO COMPARATOR

30 patients subjected to placebo daily

Drug: Placebo

Interventions

Low dose tadalafil 5 mgDRUG

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

Group A Tadalafil 5 mg
Tolterodine 4 Mg Oral Capsule, Extended ReleaseDRUG

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

Group B Tolterodine
PlaceboDRUG

Placebo drugs

Group C placebo

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samer Morsy

Cairo, 12334, Egypt

Location

MeSH Terms

Interventions

TadalafilTolterodine TartrateCapsules

Intervention Hierarchy (Ancestors)

CarbolinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndole AlkaloidsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-RingPhenylpropanolaminePropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesBenzhydryl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsCresolsPhenolsDosage FormsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Urology lecturer

Study Record Dates

First Submitted

August 3, 2020

First Posted

August 5, 2020

Study Start

December 1, 2020

Primary Completion

July 1, 2022

Study Completion

July 1, 2022

Last Updated

August 15, 2022

Record last verified: 2022-08

Locations

EG(1)