NCT02311634

Brief Summary

The purpose of this study is to determine whether electrical pudendal nerve stimulation is more effective than transvaginal electrical stimulation in treating urge urinary incontinence (UUI).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2014

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

November 19, 2014

Completed
12 days until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 8, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

August 5, 2016

Status Verified

June 1, 2015

Enrollment Period

1 year

First QC Date

November 19, 2014

Last Update Submit

August 3, 2016

Conditions

Urge Urinary Incontinence

Keywords

Electrical pudendal nerve stimulationTransvaginal electrical stimulationUrge urinary incontinenceComparative study

Outcome Measures

Primary Outcomes (2)

  • A questionnaire to measure the severity of UUI symptoms

    three or four weeks

  • 24-hour urine leakage amount

    three or four weeks

Study Arms (2)

Electrical pudendal nerve stimulation

EXPERIMENTAL

At a frequency of 2.0 Hz and a moderate intensity (25\~35 mA); 60 minutes three times a week for a total of three weeks

Device: Electrical pudendal nerve stimulation

Transvaginal ES

ACTIVE COMPARATOR

At a current intensity of \< 60 mA (in 5% increments from 0 mA to the intensity that is sensed without obvious discomfort) and frequencies of 12.5 to 30 Hz, 45 min three times a week for a total of four weeks.

Device: Transvaginal ES

Interventions

Electrical pudendal nerve stimulationDEVICE

Four sacral points are selected. The two upper points are located about 1 cm bilateral to the sacrococcygeal joint. On the upper points, a needle of 0.40 Х 100 mm is inserted perpendicularly to a depth of 80 to 90 mm to produce a sensation referred to the urethra or the anus. The locations of the two lower points are about 1 cm bilateral to the tip of the coccyx. On the lower points, a needle of 0.40 Х 100 or 125 mm is inserted obliquely towards the ischiorectal fossa to a depth of 90 to 110 mm to produce a sensation referred to the urethra. After the sensation referred to the above regions is produced, each of two pairs of electrodes from a G6805-2 Multi-Purpose Health Device is connected with the two ipsilaterally inserted needles.

Electrical pudendal nerve stimulation
Transvaginal ESDEVICE

A neuromuscular stimulation therapy system (PHENIX USB 4，Electronic Concept Lignon Innovation, France) is used for TES

Transvaginal ES

Eligibility Criteria

Age25 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • UUI history
  • Positive pad test result
  • Urodynamic study: A decrease in bladder capacity at the first desire for urination; a decrease in maximum bladder capacity; low compliance bladder

You may not qualify if:

  • UUI that can be relieved by drugs
  • Neurogenic or non-neurogenic UUI
  • Other types of incontinence such as stress incontinence and overflow incontinence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai research institute of acupuncture and meridian

Shanghai, 200030, China

Location

Related Publications (1)

  • Wang S, Zhang S, Zhao L. Long-term efficacy of electrical pudendal nerve stimulation for urgency-frequency syndrome in women. Int Urogynecol J. 2014 Mar;25(3):397-402. doi: 10.1007/s00192-013-2223-7. Epub 2013 Oct 3.

    PMID: 24091564RESULT

MeSH Terms

Conditions

Urinary Incontinence, Urge

Condition Hierarchy (Ancestors)

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

Study Officials

  • Siyou Wang, Master

    Shanghai research institute of acupuncture and meridian

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2014

First Posted

December 8, 2014

Study Start

December 1, 2014

Primary Completion

December 1, 2015

Study Completion

March 1, 2016

Last Updated

August 5, 2016

Record last verified: 2015-06

Locations

CN(1)