IDB Injection Combined With PTNS for Managing Children With OAB Not Responding to Monotherapy

NCT05911594 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2023-08-15

No results posted yet for this study

Summary

This study aimed to evaluate the outcome of simultaneous intradetrusor BOTOX (IDB) injection and Percutaneous tibial nerve stimulation (PTNS) for management of children with recurrent wetness since at least 6 months.

Conditions

  • BOTOX
  • Percutaneous Tibial Nerve Stimulation

Interventions

DRUG

Solifenacin group

Patients in this group will receive medical treatment (Solifenacin 5 mg once or twice daily) without any second line of treatment

PROCEDURE

Percutaneous tibial nerve stimulation group

Patients in this group will receive Percutaneous tibial nerve stimulation after failure of medical therapy

DRUG

Intradetrusor BOTOX group

Patients in this group will receive Intradetrusor BOTOX after failure of medical

COMBINATION_PRODUCT

Intradetrusor BOTOX combined with Percutaneous tibial nerve stimulation group

Patients in this group will receive Intradetrusor BOTOX combined with Percutaneous tibial nerve stimulation after failure of medical

Sponsors & Collaborators

  • Benha University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-14
Primary Completion
2023-02-14
Completion
2023-02-14

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05911594 on ClinicalTrials.gov