The Long-term Efficacy of Electrical Pudendal Nerve Stimulation for the Urgency-Frequency Syndrome in Women

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.

Study Overview

• Status: Completed
• Conditions: Urgency-frequency Syndrome

Detailed Description

Urgency-frequency syndrome (UFS) is often refractory to pharmacotherapy. Electrical neuromodulation has proved to be valuable in this situation. The electrical neuromodulation therapies include transvaginal electrical stimulation (TES), percutaneous tibial nerve stimulation (PTNS), sacral nerve stimulation (SNS) and pudendal nerve stimulation (PNS). Their effects can be explained by modulation of reflex pathways at spinal and supraspinal levels.

TES is easily applicable but it is sometimes intolerable for many patients due to discomfort, mucosal injury and high intensity stimulation for acceptable outcome. SNS differs from TES by its continuous stimulation and close nerve contact. It has a high rate of success, but symptoms appear to recur almost immediately after discontinuation of the stimulation and at least 20% of the patients initially tested do not respond to a test procedure. Its disadvantages included invasiveness of the procedure, the high cost of treatment, the high surgical revision rate, device replacement and adverse events. Because pudendal nerve (PN) afferents are particularly important for the inhibitory effect on the voiding reflex and SNS only excites part of PN afferents, direct PN stimulation may be more effective. PNS can be used to treat UFS refractory to SNS, but this therapy also has the disadvantages similar to those of SNS. PTNS is minimally invasive, demonstrates efficacy, and is easily applicable and well tolerated, but the results of chronic PTNS treatment are unknown in initially successful patients and PTNS effects diminish over time.

By combining the advantages of PNS and PTNS and incorporating the technique of deep insertion of long acupuncture needles, we developed electrical pudendal nerve stimulation (EPNS). In EPNS, long acupuncture needles of 0.40 Х 100 or 125 mm were deeply inserted into four sacral points and electrified to stimulate the pudendal nerves. CT transverse plane at the coccygeal apex has showed that the position of the lower needle tip is similar to where (adjacent to PN at Alcock's canal) the Bion device is implanted for chronic PN stimulation. Besides the radiographic evidence, simultaneous records of perineal ultrasonographic PFM contraction, vaginal pressure and pelvic floor surface electromyogram in our previous study have proved that EPNS can exactly excite PN. Our previous study has also proved that EPNS has a good post-treatment effect on UFS in women. The purpose of the present study is to show the long-term efficacy of EPNS for UFS in women.

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200030
    • Shanghai Research Institute of Acupuncture and Meridian

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 27 years to 81 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Shanghai Institute of Acupuncture, Moxibustion and Meridian

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2002
• Primary Completion (ACTUAL): March 1, 2012
• Study Completion (ACTUAL): May 1, 2012

Study Registration Dates

• First Submitted: August 3, 2012
• First Submitted That Met QC Criteria: August 6, 2012
• First Posted (ESTIMATE): August 7, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): August 7, 2012
• Last Update Submitted That Met QC Criteria: August 6, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: Electrical Pudendal Nerve Stimulation; Urgency-Frequency Syndrome; long-term efficacy
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Disease; Urinary Bladder, Overactive; Syndrome
• Other Study ID Numbers: 2004T004A