NCT03973983

Brief Summary

Pudendal neuralgia (PN) is a painful and disabling condition, which reduces the quality of life as well. Pudendal nerve injections are essential for the diagnosis and the management of PN. The purpose of this study was to compare the effectiveness of finger-guided transvaginal pudendal nerve injection (TV-PNI) technique and the US-guided transgluteal pudendal nerve injection (TG-PNI) technique.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2016

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

Study Start

First participant enrolled

November 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 4, 2019

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

11 months

First QC Date

June 2, 2019

Last Update Submit

February 16, 2024

Conditions

NeuralgiaPudendal NervePudendal Nerve Block

Keywords

neuralgiapudendal nervepudendal nerve blocktherapeutic local anaesthesiatransvaginal

Outcome Measures

Primary Outcomes (1)

  • Pain intensity

    Post-injection pain scores (while sitting, while/after intercourse and pain in the region from the anus to the clitoris) (ward) Pain scores were assessed with a 10-cm Visual Analogue Scale (VAS) (with 0 = no pain and 10 = the worst imaginable pain)

    180 days

Secondary Outcomes (1)

  • Block success

    180 days

Study Arms (2)

Ultrasound-guided pudendal nerve injection group

EXPERIMENTAL

Patients who received Ultrasound-guided pudendal nerve injections

Procedure: Ultrasound-guided transgluteal pudendal nerve injection (TG-PNI)

Finger-guided pudendal nerve injection group

EXPERIMENTAL

Patients who received Finger-guided pudendal nerve injections

Procedure: Finger-guided transvaginal pudendal nerve injection (TV-PNI)

Interventions

Ultrasound-guided transgluteal pudendal nerve injection (TG-PNI)PROCEDURE

Ultrasound-guided transgluteal pudendal nerve local anesthetic injections

Ultrasound-guided pudendal nerve injection group
Finger-guided transvaginal pudendal nerve injection (TV-PNI)PROCEDURE

Finger-guided transvaginal pudendal nerve local anesthetic injections

Finger-guided pudendal nerve injection group

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Positive diagnostic pudendal nerve injection (PNI)

You may not qualify if:

  • Negative diagnostic pudendal nerve injection (PNI)
  • Virgin
  • Sexual inactive

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hande G. Aytuluk

Kocaeli, Derince, 41900, Turkey (Türkiye)

Location

Related Publications (7)

  • Roth TM. Management of persistent groin pain after transobturator slings. Int Urogynecol J Pelvic Floor Dysfunct. 2007 Nov;18(11):1371-3. doi: 10.1007/s00192-007-0365-1. Epub 2007 Apr 13.

    PMID: 17431534BACKGROUND

  • Treede RD, Jensen TS, Campbell JN, Cruccu G, Dostrovsky JO, Griffin JW, Hansson P, Hughes R, Nurmikko T, Serra J. Neuropathic pain: redefinition and a grading system for clinical and research purposes. Neurology. 2008 Apr 29;70(18):1630-5. doi: 10.1212/01.wnl.0000282763.29778.59. Epub 2007 Nov 14.

    PMID: 18003941BACKGROUND

  • Vancaillie T, Eggermont J, Armstrong G, Jarvis S, Liu J, Beg N. Response to pudendal nerve block in women with pudendal neuralgia. Pain Med. 2012 Apr;13(4):596-603. doi: 10.1111/j.1526-4637.2012.01343.x. Epub 2012 Mar 5.

    PMID: 22390343BACKGROUND

  • Ramsden CE, McDaniel MC, Harmon RL, Renney KM, Faure A. Pudendal nerve entrapment as source of intractable perineal pain. Am J Phys Med Rehabil. 2003 Jun;82(6):479-84.

    PMID: 12820792RESULT

  • Labat JJ, Riant T, Robert R, Amarenco G, Lefaucheur JP, Rigaud J. Diagnostic criteria for pudendal neuralgia by pudendal nerve entrapment (Nantes criteria). Neurourol Urodyn. 2008;27(4):306-10. doi: 10.1002/nau.20505.

    PMID: 17828787RESULT

  • Kastler A, Puget J, Tiberghien F, Pellat JM, Krainik A, Kastler B. Dual Site Pudendal Nerve Infiltration: More than Just a Diagnostic Test? Pain Physician. 2018 Jan;21(1):83-90.

    PMID: 29357337RESULT

  • Fanucci E, Manenti G, Ursone A, Fusco N, Mylonakou I, D'Urso S, Simonetti G. Role of interventional radiology in pudendal neuralgia: a description of techniques and review of the literature. Radiol Med. 2009 Apr;114(3):425-36. doi: 10.1007/s11547-009-0371-0. Epub 2009 Mar 10. English, Italian.

    PMID: 19277838RESULT

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 2, 2019

First Posted

June 4, 2019

Study Start

November 1, 2016

Primary Completion

September 30, 2017

Study Completion

June 30, 2018

Last Updated

February 20, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)