A Comparison of Electrical Ilioinguinal Nerve Stimulation With Intravesical Irrigation for Bladder Pain Syndrome

NCT ID: NCT02856022

Last Updated: 2017-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2016-12-31

Brief 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.

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

Keywords

electrical ilioinguinal nerve stimulation; bladder pain syndrome; intravesical irrigation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Electrical ilioinguinal nerve stimulation

Group Type: EXPERIMENTAL

Electrical ilioinguinal nerve stimulation

Intervention Type: DEVICE

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 Irrigation

Group Type: ACTIVE_COMPARATOR

Intravesical Irrigation

Intervention Type: PROCEDURE

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 The catheter is then withdrawn leaving the Cystistat inside the bladder coating the lining.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.

Interventions

Electrical ilioinguinal nerve stimulation

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.

Intervention Type: DEVICE

Intravesical Irrigation

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Providing informed consent to participate in the study;

2. Willing to undergo a cystoscopy under general or regional anesthesia when indicated during the course of the study;

3. Female patients meeting the diagnostic criteria;

4. Age ≥18 years and ≤80 years.

5. Disease course ≥ 6 months

Exclusion Criteria

1. Bladder capacity of greater than 350 mL on awake cystometry;

2. Absence of an intense urge to void with the bladder is filled to 150 mL of liquid filling medium;

3. The demonstration of phasic involuntary bladder contractions on cystometry using the fill rate just described;

4. Duration of symptoms less than 9 months;

5. Absence of nocturia;

6. Symptoms relieved by antimicrobial agents, urinary antiseptic agents, anticholinergic agents, or antispasmodic agents;

7. A frequency of urination while awake of less than 8 times per day;

8. A diagnosis of bacterial cystitis or prostatitis within a 3-month period;

9. Bladder or ureteral calculi;

10. Active genital herpes;

11. Uterine, cervical, vaginal, or urethral cancer;

12. Urethral diverticulum;

13. Cyclophosphamide or any type of chemical cystitis;

14. Tuberculous cystitis;

15. Radiation cystitis;

16. Benign or malignant bladder tumors;

17. Vaginitis;

18. Age younger than 18 years.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Institute of Acupuncture, Moxibustion and Meridian

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Siyou Wang, M.D

Role: STUDY_DIRECTOR

Shanghai research institute of acupuncture and meridian

Locations

Shanghai research institute of acupuncture and meridian

Shanghai, , China

Countries

China

Other Identifiers

ZYY201606

Identifier Type: -

Identifier Source: org_study_id