Pelvic Pain SyndromeNCT03671993
Clinical Effect Observation for Electrical Pudendal Nerve Stimulation in Treating Urethral Pain Syndrome
A study testing Electrical pudendal nerve stimulation and Intravesical instillation in people with Pelvic Pain Syndrome, run by Shanghai Institute of Acupuncture, Moxibustion and Meridian at 1 site in China.
Trial summary
In this randomized controlled trial, we intend to determine whether electrical pudendal nerve stimulation is more effective than intravesical instillation in urethral pain syndrome. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pelvic Pain Syndrome
- What is being tested?
- Electrical pudendal nerve stimulation and Intravesical instillation
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 5 Oct 2018to 10 Mar 2019
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male or female patients aged 18 - 75
- Occurrence of chronic or recurrent episodic pain perceived in the urethra, especially related to micturition, for more than 3 months; accompanied by other symptoms such as increased daytime and night-time frequency, in the absence of proven infection or other obvious urethral pathology such as urethral diverticulum.
- Negative in urine routine test or urine cultivation.
- agreement to sign the written informed consent.
Who cannot join
- Symptoms relieved by anti-inflammatory drugs, α-blockers, muscle relaxants.
- A diagnosis of bacterial cystitis or prostatitis within a 3-month period; bladder or ureteral calculi; active genital herpes; any type of cystitis; vaginitis.
- life threatening complication such as uterine, cervical, vaginal, or urethral cancer, bladder tumor, heart failure, cardiovascular disease, hemorrhagic disease, uncontrolled diabetes, and/or factors that can affect hemostasis.
- Female patients with pregnancy or lactation.
- Serious mental disorders.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai research institute of acupuncture and meridian
Shanghai, 200030
About this study
In this randomized controlled trial, we intend to determine whether electrical pudendal nerve stimulation is more effective than intravesical instillation in urethral pain syndrome.
Read the detailed description
According to the 2017 edition of European Association of Urology Guideline, there is no specific treatment for urethral pain syndrome (UPS), and it is recommended this type of patients should be treated in a multi-disciplinary and multi-modal program. Since some mechanisms for the development of UPS suggest it may be a form of bladder pain syndrome (BPS) due to the intimate relation of the urethra with the bladder (both covered with urothelium), a combination of intravesical hyaluronic acid and lidocaine plus sodium bicarbonate, the more widely used regimen for BPS in China, is also applied to UPS here in China. However, the symptom relief of the intravesical irrigation won't last long and patients usually report recurrence in 2-3 weeks. Hence, the purpose of this study is to explore whether the electrical pudendal nerve stimulation（EPNS）, which has been proven effective in treating BPS, is more effective than intravesical instillation (intravesical hyaluronic acid and lidocaine plus sodium bicarbonate) in patients with UPS.
- Conditions
- Pelvic Pain Syndrome
- Being tested
- Electrical pudendal nerve stimulation, Intravesical instillation
- Keywords
- urethral pain syndrome, electrical pudendal nerve stimulation, intravesical instillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical pudendal nerve stimulationProcedure or surgery
Four sacrococcygeal points were selected. Two 0.40Х100 mm needles were inserted perpendicularly to a depth of 80-90 mm 1 cm bilateral to the sacrococcygeal joint, to produce a sensation referred to the root of the penis (perineum) or the anus. Two needles of 0.40Х100 or 125mm were inserted obliquely toward the ischiorectal fossa to a depth of 90 to 110 mm about 1 cm bilateral to the tip of the coccyx, to produce a sensation referred to the root of the penis (or the perineum). Each two ipsilaterally needles were connected to one electrode from a G6805-2Multi-Purpose Health Device (Shanghai Medical Instruments High-Techno, Shanghai, China), with a frequency of 2.5 Hz and an intensity (45~55 mA). EPNS was given for 60 min a time, 3 sessions per week for 6 weeks.
Intravesical instillationProcedure or surgery
The patient should lie on a couch in a lithotomy position after urination. A catheter was passed through the urethra into the bladder and any residual urine should be drained. A mixture of the Cystistat (sodium hyaluronate, 50ml 40mg, Bioniche Teoranta, Ireland) solution and Lidocaine hydrochloride (40mg :20ml, Fangming Pharmacy company, Shangdong, China) is instilled through the catheter into the bladder. The catheter is then withdrawn leaving the mixture solution inside the bladder, retained for as long as possible, ideally at least 30 minutes. The instillation is once weekly for at 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| EPNS group | Experimental | Electrical pudendal nerve stimulation (EPNS) is a type of conservative treatment which can directly modulate the pudendal nerve and produce a regulation effects on both the sensory fibers and the motor fibers of pudendal nerve. Receives: Procedure: Electrical pudendal nerve stimulation |
| II group | Active comparator | Intravesical instillation (II) are mixture solution administered due to poor oral bio-availability establishing high drug concentrations within the bladder, with few systemic side-effects. Receives: Procedure: Intravesical instillation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic Pain, Urgency and Frequency Questionnaire ( PUF questionnaire)
This instrument consists of eight items that cover areas of pain, urgency, urinary frequency, and symptoms associated with sexual intercourse. The score ranges from 0 to 35 points. Each participant will be evaluated by using the PUF at baseline, three weeks after the treatment commencement and six weeks after the treatment commencement, and we are about to record the mean change of the overall score of this questionnaire.
Measured: 6 weeks
Secondary outcomes (1)
Visual Analogue Scale for pain
Participants will be asked to mark the degree of pain in urethral on a 10-mm VAS, with "0" indicating no pain and "10" indicating the worst painimaginable. Each participant will be evaluated by using this instrument at baseline, three weeks after the treatment commencement and six weeks after the treatment commencement, and we are about to record the mean change of the score.
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 posted14 Sep 2018
- Study start5 Oct 2018
- Primary completion10 Feb 2019
- Study completion10 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pelvic Pain 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 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, Study director, Shanghai research institute of acupuncture and meridian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03671993
- Sponsor's protocol ID
- ShanghaiIAMM
- Status last verified
- Sep 2018
- First submitted
- 4 Sep 2018
- Last updated
- 3 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Li T, Feng XY, Feng XM, Lv JW, Lv TT, Wang SY. The short-term efficacy of electrical pudendal nerve stimulation versus intravesical instillation for the urethral pain syndrome: a randomized clinical trial. World J Urol. 2021 Oct;39(10):3993-3998. doi: 10.1007/s00345-021-03698-2. Epub 2021 May 2.
PubMed 33934208
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effect Observation for Electrical Pudendal Nerve Stimulation in Treating Urethral Pain Syndrome
- ClinicalTrials.gov ID
- NCT03671993
- Acronym / sponsor ID
- ShanghaiIAMM
- Conditions
- Pelvic Pain Syndrome
- Keywords
- urethral pain syndrome, electrical pudendal nerve stimulation, intravesical instillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Shanghai Institute of Acupuncture, Moxibustion and MeridianUniversity, hospital or other
- Study start
- 5 Oct 2018 (actual)
- Primary completion
- 10 Feb 2019 (actual)
- Study completion
- 10 Mar 2019 (actual)
- First posted
- 14 Sep 2018 (actual)
- 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.
In this randomized controlled trial, we intend to determine whether electrical pudendal nerve stimulation is more effective than intravesical instillation in urethral pain syndrome.
Detailed description
According to the 2017 edition of European Association of Urology Guideline, there is no specific treatment for urethral pain syndrome (UPS), and it is recommended this type of patients should be treated in a multi-disciplinary and multi-modal program. Since some mechanisms for the development of UPS suggest it may be a form of bladder pain syndrome (BPS) due to the intimate relation of the urethra with the bladder (both covered with urothelium), a combination of intravesical hyaluronic acid and lidocaine plus sodium bicarbonate, the more widely used regimen for BPS in China, is also applied to UPS here in China. However, the symptom relief of the intravesical irrigation won't last long and patients usually report recurrence in 2-3 weeks. Hence, the purpose of this study is to explore whether the electrical pudendal nerve stimulation（EPNS）, which has been proven effective in treating BPS, is more effective than intravesical instillation (intravesical hyaluronic acid and lidocaine plus sodium bicarbonate) in patients with UPS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EPNS group | Experimental | Procedure: Electrical pudendal nerve stimulationElectrical pudendal nerve stimulation (EPNS) is a type of conservative treatment which can directly modulate the pudendal nerve and produce a regulation effects on both the sensory fibers and the motor fibers of pudendal nerve. |
| II group | Active comparator | Procedure: Intravesical instillationIntravesical instillation (II) are mixture solution administered due to poor oral bio-availability establishing high drug concentrations within the bladder, with few systemic side-effects. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- male or female patients aged 18 - 75
- Occurrence of chronic or recurrent episodic pain perceived in the urethra, especially related to micturition, for more than 3 months; accompanied by other symptoms such as increased daytime and night-time frequency, in the absence of proven infection or other obvious urethral pathology such as urethral diverticulum.
- Negative in urine routine test or urine cultivation.
- agreement to sign the written informed consent.
Key exclusion criteria (5 listed)
- Symptoms relieved by anti-inflammatory drugs, α-blockers, muscle relaxants.
- A diagnosis of bacterial cystitis or prostatitis within a 3-month period; bladder or ureteral calculi; active genital herpes; any type of cystitis; vaginitis.
- life threatening complication such as uterine, cervical, vaginal, or urethral cancer, bladder tumor, heart failure, cardiovascular disease, hemorrhagic disease, uncontrolled diabetes, and/or factors that can affect hemostasis.
- Female patients with pregnancy or lactation.
- Serious mental disorders.
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 |
|---|---|---|
| Electrical pudendal nerve stimulationFour sacrococcygeal points were selected. Two 0.40Х100 mm needles were inserted perpendicularly to a depth of 80-90 mm 1 cm bilateral to the sacrococcygeal joint, to produce a sensation referred to the root of the penis (perineum) or the anus. Two needles of 0.40Х100 or 125mm were inserted obliquely toward the ischiorectal fossa to a depth of 90 to 110 mm about 1 cm bilateral to the tip of the coccyx, to produce a sensation referred to the root of the penis (or the perineum). Each two ipsilaterally needles were connected to one electrode from a G6805-2Multi-Purpose Health Device (Shanghai Medical Instruments High-Techno, Shanghai, China), with a frequency of 2.5 Hz and an intensity (45~55 mA). EPNS was given for 60 min a time, 3 sessions per week for 6 weeks. | Procedure or surgery | EPNS group |
| Intravesical instillationThe patient should lie on a couch in a lithotomy position after urination. A catheter was passed through the urethra into the bladder and any residual urine should be drained. A mixture of the Cystistat (sodium hyaluronate, 50ml 40mg, Bioniche Teoranta, Ireland) solution and Lidocaine hydrochloride (40mg :20ml, Fangming Pharmacy company, Shangdong, China) is instilled through the catheter into the bladder. The catheter is then withdrawn leaving the mixture solution inside the bladder, retained for as long as possible, ideally at least 30 minutes. The instillation is once weekly for at 6 weeks. | Procedure or surgery | II group |
Primary outcome
Pelvic Pain, Urgency and Frequency Questionnaire ( PUF questionnaire)
Time frame: 6 weeks
This instrument consists of eight items that cover areas of pain, urgency, urinary frequency, and symptoms associated with sexual intercourse. The score ranges from 0 to 35 points. Each participant will be evaluated by using the PUF at baseline, three weeks after the treatment commencement and six weeks after the treatment commencement, and we are about to record the mean change of the overall score of this questionnaire.
1 secondary outcome
Visual Analogue Scale for pain
Time frame: 6 weeks
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 3 Dec 2019.
- Derived from this study: PubMed 33934208Li T, Feng XY, Feng XM, Lv JW, Lv TT, Wang SY. The short-term efficacy of electrical pudendal nerve stimulation versus intravesical instillation for the urethral pain syndrome: a randomized clinical trial. World J Urol. 2021 Oct;39(10):3993-3998. doi: 10.1007/s00345-021-03698-2. Epub 2021 May 2.
- 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 study director
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?
A study testing Electrical pudendal nerve stimulation and Intravesical instillation in people with Pelvic Pain 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 4 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 3 Dec 2019. 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?
Pelvic Pain, Urgency and Frequency Questionnaire ( PUF questionnaire) (time frame: 6 weeks). 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 NCT03671993, which also lists 1 linked publication.
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 3 Dec 2019; AzTrials last refreshed its copy on 1 Nov 2026.