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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shanghai Institute of Acupuncture, Moxibustion and Meridian
ClinicalTrials.gov Identifier:
NCT01659216
First received: August 3, 2012
Last updated: August 6, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition
Urgency-frequency Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Long-term Efficacy of Electrical Pudendal Nerve Stimulation for the Urgency-Frequency Syndrome in Women

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Shanghai Institute of Acupuncture, Moxibustion and Meridian:

Primary Outcome Measures:
  • A questionnaire to measure the severity of UFS symptoms [ Time Frame: five years ] [ Designated as safety issue: No ]
    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.


Enrollment: 90
Study Start Date: January 2002
Study Completion Date: May 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   27 Years to 81 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01659216

Locations
China
Shanghai research institute of acupuncture and meridian
Shanghai, China, 200030
Sponsors and Collaborators
Shanghai Institute of Acupuncture, Moxibustion and Meridian
Investigators
Study Chair: Siyou Wang, Master Shanghai research institute of acupuncture and meridian
  More Information

Publications:

Responsible Party: Shanghai Institute of Acupuncture, Moxibustion and Meridian
ClinicalTrials.gov Identifier: NCT01659216     History of Changes
Other Study ID Numbers: 2004T004A
Study First Received: August 3, 2012
Last Updated: August 6, 2012
Health Authority: China: Science and Technology Commission of Shanghai Municipality

Keywords provided by Shanghai Institute of Acupuncture, Moxibustion and Meridian:
Electrical Pudendal Nerve Stimulation
Urgency-Frequency Syndrome
long-term efficacy

ClinicalTrials.gov processed this record on June 18, 2013