NCT01659216

Brief Summary

The purpose of this study is to determine whether electrical pudendal nerve stimulation with acupuncture needles as electrodes has a good long-term therapeutic effect on the urgency-frequency syndrome in women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2002

Longer than P75 for all trials

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

January 1, 2002

Completed
10.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 7, 2012

Completed
Last Updated

August 7, 2012

Status Verified

August 1, 2012

Enrollment Period

10.2 years

First QC Date

August 3, 2012

Last Update Submit

August 6, 2012

Conditions

Urgency-frequency Syndrome

Keywords

Electrical Pudendal Nerve StimulationUrgency-Frequency Syndromelong-term efficacy

Outcome Measures

Primary Outcomes (1)

  • A questionnaire to measure the severity of UFS symptoms

    A questionnaire including questions on storage symptoms: urgency, frequency, nocturia, incontinence and bladder pain; on voiding symptoms: hesitancy, intermittency, slow stream, straining and burning; on post micturition symptoms: incomplete emptying and post micturition dribble.

    five years

Study Arms (1)

patients improved by EPNS; follow-up

Ninety female UFS patients with ≥50% symptom improvement at the end of EPNS treatment (Jul. 2001 to Jun. 2005) were followed up by a telephone questionnaire for at least 5 years.

Eligibility Criteria

Age27 Years - 81 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

female UFS patients with ≥50% symptom improvement at the end of EPNS treatment

You may qualify if:

  • ≥50% symptom improvement at the end of EPNS treatment

You may not qualify if:

  • Lost to follow-up or dead at 5 years after the end of treatment
  • The symptoms were further relieved by other therapies during follow-up

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 (2)

  • Wang S, Zhang S. Simultaneous perineal ultrasound and vaginal pressure measurement prove the action of electrical pudendal nerve stimulation in treating female stress incontinence. BJU Int. 2012 Nov;110(9):1338-43. doi: 10.1111/j.1464-410X.2012.11029.x. Epub 2012 Mar 15.

    PMID: 22417077BACKGROUND

  • 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: 24091564DERIVED

Study Officials

  • Siyou Wang, Master

    Shanghai research institute of acupuncture and meridian

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2012

First Posted

August 7, 2012

Study Start

January 1, 2002

Primary Completion

March 1, 2012

Study Completion

May 1, 2012

Last Updated

August 7, 2012

Record last verified: 2012-08

Locations

CN(1)