Urgency-frequency SyndromeNCT01659216
The Long-term Efficacy of Electrical Pudendal Nerve Stimulation for the Urgency-Frequency Syndrome in Women
An observational study of Urgency-frequency Syndrome, run by Shanghai Institute of Acupuncture, Moxibustion and Meridian at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 27 to 81 years, women only
- Conditions the study is for
- Urgency-frequency Syndrome
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- Jan 2002to May 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 27 to 81 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: female UFS patients with ≥50% symptom improvement at the end of EPNS treatment
Who may be able to join
- ≥50% symptom improvement at the end of EPNS treatment
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai research institute of acupuncture and meridian
Shanghai, 200030
About this study
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.
Read the 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.
- Conditions
- Urgency-frequency Syndrome
- Keywords
- Electrical Pudendal Nerve Stimulation, Urgency-Frequency Syndrome, long-term efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2012 (estimated)
- Study startJan 2002
- Primary completionMar 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Urgency-frequency SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Institute of Acupuncture, Moxibustion and Meridian
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Siyou Wang, Master, Study chair, Shanghai research institute of acupuncture and meridian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01659216
- Sponsor's protocol ID
- 2004T004A
- Status last verified
- Aug 2012
- First submitted
- 3 Aug 2012
- Last updated
- 7 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 22417077Wang 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.
PubMed 24091564
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Long-term Efficacy of Electrical Pudendal Nerve Stimulation for the Urgency-Frequency Syndrome in Women
- ClinicalTrials.gov ID
- NCT01659216
- Acronym / sponsor ID
- 2004T004A
- Conditions
- Urgency-frequency Syndrome
- Keywords
- Electrical Pudendal Nerve Stimulation, Urgency-Frequency Syndrome, long-term efficacy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Shanghai Institute of Acupuncture, Moxibustion and MeridianUniversity, hospital or other
- Study start
- Jan 2002
- Primary completion
- Mar 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 7 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 27 to 81 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- female UFS patients with ≥50% symptom improvement at the end of EPNS treatment
Key inclusion criteria (1 listed)
- ≥50% symptom improvement at the end of EPNS treatment
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
A questionnaire to measure the severity of UFS symptoms
Time frame: five years
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2012.
- Background: PubMed 22417077Wang 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.
- Derived from this study: PubMed 24091564Wang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Siyou Wang, Master study chair
Shanghai research institute of acupuncture and meridian
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urgency-frequency Syndrome, run by Shanghai Institute of Acupuncture, Moxibustion and Meridian at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A questionnaire to measure the severity of UFS symptoms (time frame: five years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01659216, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2012.