Painful Bladder SyndromeNCT02856022
A Comparison of Electrical Ilioinguinal Nerve Stimulation With Intravesical Irrigation for Bladder Pain Syndrome
A study testing Electrical ilioinguinal nerve stimulation and Intravesical Irrigation in people with Painful Bladder 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 ilioinguinal nerve stimulation (EINS) is more effective than intravesical irrigation (II) in treating bladder pain syndrome. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Painful Bladder Syndrome
- What is being tested?
- Electrical ilioinguinal nerve stimulation and Intravesical Irrigation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Jul 2014to Dec 2016
- 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
- Providing informed consent to participate in the study;
- Willing to undergo a cystoscopy under general or regional anesthesia when indicated during the course of the study;
- Female patients meeting the diagnostic criteria;
- Age ≥18 years and ≤80 years.
- Disease course ≥ 6 months
Who cannot join
- Bladder capacity of greater than 350 mL on awake cystometry;
- Absence of an intense urge to void with the bladder is filled to 150 mL of liquid filling medium;
- The demonstration of phasic involuntary bladder contractions on cystometry using the fill rate just described;
- Duration of symptoms less than 9 months;
- Absence of nocturia;
- Symptoms relieved by antimicrobial agents, urinary antiseptic agents, anticholinergic agents, or antispasmodic agents;
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- A frequency of urination while awake of less than 8 times per day;
- A diagnosis of bacterial cystitis or prostatitis within a 3-month period;
- Bladder or ureteral calculi;
- Active genital herpes;
- Uterine, cervical, vaginal, or urethral cancer;
- Urethral diverticulum;
- Cyclophosphamide or any type of chemical cystitis;
- Tuberculous cystitis;
- Radiation cystitis;
- Benign or malignant bladder tumors;
- Vaginitis;
- Age younger than 18 years.
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 of the Efficacy of Electrical Ilioinguinal Nerve Stimulation and Intravesical Irrigation in Treating Patients With Bladder Pain Syndrome in Women
The purpose of this study is to determine whether electrical ilioinguinal nerve stimulation (EINS) is more effective than intravesical irrigation (II) in treating bladder pain syndrome.
Read the detailed description
The purpose of this study is to determine whether electrical ilioinguinal nerve stimulation (EINS) is more effective than intravesical irrigation (II) in treating bladder pain syndrome.
- Conditions
- Painful Bladder Syndrome
- Being tested
- Electrical ilioinguinal nerve stimulation, Intravesical Irrigation
- Keywords
- electrical ilioinguinal nerve stimulation, bladder pain syndrome, intravesical irrigation
- Medical subject headings
- Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical ilioinguinal nerve stimulationDevice
Four abdominal points are selected. The upper two points are located 2.5 cun bilateral to Guanyuan (Ren 4). The lower two points are located 1.5 cun bilateral to Zhongji (Ren 3). Four long needles are punctured obliquely 1~2 cun in depth (depending on the fat layer thickness of the patient) to the four points to make the needling sensation reaching the urethra or vulva.
After the needling sensation reach the above regions, each of two pairs of electrodes from a device are connected with the two ipsilaterally inserted needles. The parameters are continuous waves, a frequency of 2.5 Hz and intensity that the patient feels comfortable for 60 min, three times a week for at least four weeks.
Intravesical IrrigationProcedure or surgery
The patient was asked to lie on a couch in a lithotomy position after urination. A catheter was passed through the urethra into the bladder and any residual urine drained. The Cystistat 50mL 40mg (sodium hyaluronate, Bioniche Teoranta, Ireland) solution is instilled through the catheter into the bladder. The catheter is then withdrawn leaving the Cystistat inside the bladder coating the lining. It was recommended the solution was retained for as long as possible, ideally at least 30 minutes. The instillation is once weekly for at least four weeks.
| Study group | Role | What they receive |
|---|---|---|
| Electrical ilioinguinal nerve stimulation | Experimental | Not described Receives: Device: Electrical ilioinguinal nerve stimulation |
| Intravesical Irrigation | Active comparator | Not described Receives: Procedure: Intravesical Irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bladder Pain/ Interstitial Cystitis Symptom Score (BPIC-SS)
Measured: 4 weeks
Secondary outcomes (1)
SF-36 questionnaire
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2016 (estimated)
- Study startJul 2014
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Painful Bladder 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
- None (open label)
- Enrolment
- 60 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, M.D, Study director, Shanghai research institute of acupuncture and meridian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02856022
- Sponsor's protocol ID
- ZYY201606
- Status last verified
- Jun 2016
- First submitted
- 2 Aug 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 of the Efficacy of Electrical Ilioinguinal Nerve Stimulation and Intravesical Irrigation in Treating Patients With Bladder Pain Syndrome in Women
- ClinicalTrials.gov ID
- NCT02856022
- Acronym / sponsor ID
- ZYY201606
- Conditions
- Painful Bladder Syndrome
- Keywords
- electrical ilioinguinal nerve stimulation, bladder pain syndrome, intravesical irrigation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Shanghai Institute of Acupuncture, Moxibustion and MeridianUniversity, hospital or other
- Study start
- Jul 2014 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 4 Aug 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 determine whether electrical ilioinguinal nerve stimulation (EINS) is more effective than intravesical irrigation (II) in treating bladder pain syndrome.
Detailed description
The purpose of this study is to determine whether electrical ilioinguinal nerve stimulation (EINS) is more effective than intravesical irrigation (II) in treating bladder pain syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electrical ilioinguinal nerve stimulation | Experimental | Device: Electrical ilioinguinal nerve stimulation |
| Intravesical Irrigation | Active comparator | Procedure: Intravesical Irrigation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Providing informed consent to participate in the study;
- Willing to undergo a cystoscopy under general or regional anesthesia when indicated during the course of the study;
- Female patients meeting the diagnostic criteria;
- Age ≥18 years and ≤80 years.
- Disease course ≥ 6 months
Key exclusion criteria (18 listed)
- Bladder capacity of greater than 350 mL on awake cystometry;
- Absence of an intense urge to void with the bladder is filled to 150 mL of liquid filling medium;
- The demonstration of phasic involuntary bladder contractions on cystometry using the fill rate just described;
- Duration of symptoms less than 9 months;
- Absence of nocturia;
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 ilioinguinal nerve stimulationFour abdominal points are selected. The upper two points are located 2.5 cun bilateral to Guanyuan (Ren 4). The lower two points are located 1.5 cun bilateral to Zhongji (Ren 3). Four long needles are punctured obliquely 1~2 cun in depth (depending on the fat layer thickness of the patient) to the four points to make the needling sensation reaching the urethra or vulva. After the needling sensation reach the above regions, each of two pairs of electrodes from a device are connected with the two ipsilaterally inserted needles. The parameters are continuous waves, a frequency of 2.5 Hz and intensity that the patient feels comfortable for 60 min, three times a week for at least four weeks. | Device | Electrical ilioinguinal nerve stimulation |
| Intravesical IrrigationThe patient was asked to lie on a couch in a lithotomy position after urination. A catheter was passed through the urethra into the bladder and any residual urine drained. The Cystistat 50mL 40mg (sodium hyaluronate, Bioniche Teoranta, Ireland) solution is instilled through the catheter into the bladder. The catheter is then withdrawn leaving the Cystistat inside the bladder coating the lining. It was recommended the solution was retained for as long as possible, ideally at least 30 minutes. The instillation is once weekly for at least four weeks. | Procedure or surgery | Intravesical Irrigation |
Primary outcome
Bladder Pain/ Interstitial Cystitis Symptom Score (BPIC-SS)
Time frame: 4 weeks
1 secondary outcome
SF-36 questionnaire
Time frame: 4 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 31 Jul 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Painful Bladder Syndrome
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Bladder Directed vs. Pelvic Floor Therapy in IC/BPS
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Genetic Study of Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
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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, M.D 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 ilioinguinal nerve stimulation and Intravesical Irrigation in people with Painful Bladder 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 5 inclusion and 18 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?
Bladder Pain/ Interstitial Cystitis Symptom Score (BPIC-SS) (time frame: 4 weeks). 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; AzTrials last refreshed its copy on 7 Nov 2026.