Urgency-frequency SyndromeNCT02723279
Comparison of Electrical Pudendal Nerve Stimulation and Tolterodine Tartrate for Urgency-Frequency Syndrome in Women
A study testing EPNS and TT in people with 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 compare the efficacy of electrical pudendal nerve stimulation (EPNS) and Tolterodine Tartrate in patients with urgency-frequency syndrome. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Urgency-frequency Syndrome
- What is being tested?
- EPNS and TT
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Apr 2016to Mar 2017
- Phase
- Interventional
- 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 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Urgency with a documented daytime frequency of more than eight voids and/or nocturia of more than one void.
Who cannot join
- Age <18 years,or >80 years;
- Urinary tract infections based on results of urinalysis or urine culture;
- Painful bladder syndrome manifested by suprapubic pain related to bladder filling accompanied by frequency and other diseases (including interstitial cystitis, neurogenic bladder, bladder tumor, and vesical calculus)
- Causative of urgency and frequency confirmed by physical examination, B-scan ultrasonography.
- urodynamic study, cystoscopy, and radiography
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai research institute of acupuncture and meridian
Shanghai, 200030
About this study
Official title: A Comparison Study on Efficacies of Electrical Pudendal Nerve Stimulation and Tolterodine Tartrate for Urgency-Frequency Syndrome in Women
The purpose of this study is to compare the efficacy of electrical pudendal nerve stimulation (EPNS) and Tolterodine Tartrate in patients with urgency-frequency syndrome.
Read the detailed description
Tolterodine Tartrate is one of the first-line medications in treatment of Urgency-frequency syndrome (UFS) patients. It is reported to reduce frequency urgency and nocturia and urinary leakage in patients with UFS. However dry mouth and constipation are the most frequently reported adverse events. In other reports blurred vision and increased heart rate are also reported. The side effects limit its application.
Electrical neuromodulation has proved to be valuable in patients with UFS with little adverse effect. The investigators have previously reported electrical pudendal nerve stimulation (EPNS) alone has long term effect in treatment of UFS in women patients. EPNS is developed by combining the advantages of pudendal nerve stimulation (PNS) and percutaneous tibial nerve stimulation (PTNS), and incorporating the technique of deep insertion of long acupuncture needles. 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.
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 the investigators previous study have proved that EPNS can exactly excite PN. The investigators 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
- Being tested
- EPNS, TT
- Keywords
- Urgency-frequency Syndrome, Electrical Pudendal Nerve Stimulation, Tolterodine Tartrate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPNSBehavioural
Also called electrical pudendal nerve stimulation
Electrical pudendal nerve stimulation 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.
TTDrug
Also called Tolterodine tartrate
Tolterodine tartrate (GSK， UK) 4mg per day is taken orally for six weeks
| Study group | Role | What they receive |
|---|---|---|
| EPNS group | Experimental | Not described Receives: Behavioral: EPNS |
| TT group | Active comparator | Not described Receives: Drug: TT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower urinary tract syndrome score
International Consultation on Incontinence Questionnaire-Female Lower Urinary Tract Symptoms (ICIQ-FLUTS) is used
Measured: 6 weeks
Quality of life score
International Consultation on Incontinence Questionnaire-Quality of life (ICIQ-qol) is used
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2016 (estimated)
- Study startApr 2016
- Primary completionOct 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Institute of Acupuncture, Moxibustion and Meridian
- Sponsor type
- University, hospital or other
- Collaborators
- RenJi Hospital
- Responsible party
- Sponsor
- Investigators
- Siyou Wang, Principal investigator, Shanghai University of Traditional Chinese Medicine affliated Yueyang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02723279
- Sponsor's protocol ID
- 201512ZYSUFS
- Status last verified
- Jul 2017
- First submitted
- 24 Mar 2016
- Last updated
- 31 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Study on Efficacies of Electrical Pudendal Nerve Stimulation and Tolterodine Tartrate for Urgency-Frequency Syndrome in Women
- ClinicalTrials.gov ID
- NCT02723279
- Acronym / sponsor ID
- 201512ZYSUFS
- Conditions
- Urgency-frequency Syndrome
- Keywords
- Urgency-frequency Syndrome, Electrical Pudendal Nerve Stimulation, Tolterodine Tartrate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Shanghai Institute of Acupuncture, Moxibustion and MeridianUniversity, hospital or other
- Collaborators
- RenJi Hospital
- Study start
- Apr 2016 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 30 Mar 2016 (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 compare the efficacy of electrical pudendal nerve stimulation (EPNS) and Tolterodine Tartrate in patients with urgency-frequency syndrome.
Detailed description
Tolterodine Tartrate is one of the first-line medications in treatment of Urgency-frequency syndrome (UFS) patients. It is reported to reduce frequency urgency and nocturia and urinary leakage in patients with UFS. However dry mouth and constipation are the most frequently reported adverse events. In other reports blurred vision and increased heart rate are also reported. The side effects limit its application.
Electrical neuromodulation has proved to be valuable in patients with UFS with little adverse effect. The investigators have previously reported electrical pudendal nerve stimulation (EPNS) alone has long term effect in treatment of UFS in women patients. EPNS is developed by combining the advantages of pudendal nerve stimulation (PNS) and percutaneous tibial nerve stimulation (PTNS), and incorporating the technique of deep insertion of long acupuncture needles. 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.
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 the investigators previous study have proved that EPNS can exactly excite PN. The investigators 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EPNS group | Experimental | Behavioral: EPNS |
| TT group | Active comparator | Drug: TT |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Urgency with a documented daytime frequency of more than eight voids and/or nocturia of more than one void.
Key exclusion criteria (5 listed)
- Age <18 years,or >80 years;
- Urinary tract infections based on results of urinalysis or urine culture;
- Painful bladder syndrome manifested by suprapubic pain related to bladder filling accompanied by frequency and other diseases (including interstitial cystitis, neurogenic bladder, bladder tumor, and vesical calculus)
- Causative of urgency and frequency confirmed by physical examination, B-scan ultrasonography.
- urodynamic study, cystoscopy, and radiography
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EPNSAlso: electrical pudendal nerve stimulationElectrical pudendal nerve stimulation 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. | Behavioural | EPNS group |
| TTAlso: Tolterodine tartrateTolterodine tartrate (GSK， UK) 4mg per day is taken orally for six weeks | Drug | TT group |
Primary outcome
Lower urinary tract syndrome score
Time frame: 6 weeks
International Consultation on Incontinence Questionnaire-Female Lower Urinary Tract Symptoms (ICIQ-FLUTS) is used
Quality of life score
Time frame: 6 weeks
International Consultation on Incontinence Questionnaire-Quality of life (ICIQ-qol) is used
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 31 Jul 2017.
- Individual participant dataSharing planned: Undecided
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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 principal investigator
Shanghai University of Traditional Chinese Medicine affliated Yueyang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EPNS and TT in people with 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 5 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 31 Jul 2017. 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?
Lower urinary tract syndrome score (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jul 2017.