NCT03385460

Brief Summary

We hypothesize that LESWs might temporarily increase urothelial permeability and facilitate delivery of intravesical botulinum toxin without the need for injection.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 24, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 28, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

December 28, 2017

Status Verified

December 1, 2017

Enrollment Period

1.9 years

First QC Date

December 13, 2017

Last Update Submit

December 27, 2017

Conditions

Overactive BladderBotulinum ToxinIntravesicalESWL

Keywords

Overactive bladderBotulinum Toxinlow energy shock wavesIntravesical

Outcome Measures

Primary Outcomes (1)

  • Efficacy of Intravesical Botulinum Toxin A Delivery Using Low Energy Shock Waves for management of OAB: Pressure flow urodynamics measured in cm/H2O

    pressure flow urodynamics will be measured in cm/H2O

    1 year

Secondary Outcomes (1)

  • Impact of the new technique on the quality of life based on QOL score

    1 year

Study Arms (1)

ESWL BOTOX

EXPERIMENTAL

Each patient will be subjected to Low Energy Shock Waves.The target dose of low energy shock waves will be 3000 shock delivered into SP region in 3 horizontal points at SP transverse crease . all patients will be catheterized using nylaton catheter 16 ch, the study group will be injected with 100 IU botulinium toxin A. vial will be dissolved in saline half of the estimated bladder capacity. All patients will be kept for 2 hours without micturation giving a chance of BOTOX absorption .

Other: ESWL BOTOX

Interventions

ESWL BOTOXOTHER

ESWL after intrravesical BOTOX

ESWL BOTOX

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • OAB refractory to treatment with antimuscarinics for 2 months

You may not qualify if:

  • Sensitivity to botox
  • Neurogenic detrusor overactivity
  • Active UTI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology and nephrology center

Al Mansurah, 35516, Egypt

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Msc

Study Record Dates

First Submitted

December 13, 2017

First Posted

December 28, 2017

Study Start

January 24, 2017

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

December 28, 2017

Record last verified: 2017-12

Locations

EG(1)