NCT03280316

Brief Summary

The investigators' goal is to compare the efficacy of three different management strategies (sacral neuromodulation, botulinum toxin, M receptor antagonist) in treating consistent OAB in patients with SVMs after surgery.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Status
unknown

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

September 8, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2017

Completed
5.3 years until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

April 29, 2020

Status Verified

April 1, 2020

Enrollment Period

9 months

First QC Date

September 8, 2017

Last Update Submit

April 28, 2020

Conditions

Spinal Vascular Disorder NosOveractive Bladder

Keywords

Spinal Vascular DisorderOveractive Bladder

Outcome Measures

Primary Outcomes (1)

  • bladder function

    bladder function change in urodynamics

    3 months and 12 months

Study Arms (3)

patients with SVMs undergoing SNM

EXPERIMENTAL

patients with SVMs are of consistent OAB (Overactive Bladder) after surgery and undergo sacral neuromodulation (SNM)

Procedure: surgeryProcedure: sacral neuromodulation

patients with SVMs receiving BTXA

EXPERIMENTAL

patients with SVMs are of consistent OAB after surgery and accept botulinum toxin A (BTXA) injection

Procedure: surgeryProcedure: botulinum toxin A injection

patients with SVMs receiving drug

EXPERIMENTAL

patients with SVMs are of consistent OAB (Overactive Bladder) after surgery and accept M receptor antagonist

Procedure: surgeryDrug: M receptor antagonist

Interventions

surgeryPROCEDURE

patients with SVMs receive surgery

patients with SVMs receiving BTXApatients with SVMs receiving drugpatients with SVMs undergoing SNM
sacral neuromodulationPROCEDURE

sacral neuromodulation (SNM) with InterStimTM

patients with SVMs undergoing SNM
botulinum toxin A injectionPROCEDURE

BOTOX

patients with SVMs receiving BTXA
M receptor antagonistDRUG

Tolterodine

Also known as: Tolterodine
patients with SVMs receiving drug

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient diagnosed with spinal vascular diseases including Intradural arteriovenous malformation,Intradural arteriovenous fistula,Dural arteriovenous fistula,Extradural arteriovenous malformation,Paravertebral arteriovenous malformation,Paravertebral arteriovenous fistula,cobbs' syndrome,and other spinal arteriovenous metameric syndromes involve the spinal cord.
  • patient not received surgical or interventional treatment before
  • patient with normal cardiac, renal and hepatic function
  • patient capable of understanding the content of the patient information / Informed Consent Form
  • patient willing and able to participate in the registry
  • patients have consistent OAB after surgery

You may not qualify if:

  • patient received surgical treatment or interventional treatment before
  • patient is pregnant
  • patient allergic to iodine
  • patient unable to complete follow-up
  • patient with cerebral lesions
  • patient with other spinal lesions
  • patient with cardiac, renal or hepatic dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Surgical Procedures, OperativeBotulinum Toxins, Type ATolterodine Tartrate

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

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological FactorsPhenylpropanolaminePropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesBenzhydryl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsCresolsPhenols

Study Officials

  • tongwen ou, M.D

    Xuanwu Hospital, Beijing

    STUDY DIRECTOR

Central Study Contacts

zhenhua shang, M.D

CONTACT

17801117318shangzhenhua16@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Urology

Study Record Dates

First Submitted

September 8, 2017

First Posted

September 12, 2017

Study Start

January 1, 2023

Primary Completion

October 1, 2023

Study Completion

December 1, 2023

Last Updated

April 29, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share