Skip to main content
OpenTrials
Completed

NCT Number: NCT02856022

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai research institute of acupuncture and meridian

Shanghai, 200030, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Diagnostic Criteria:

  • Complaint of suprapubic pain related to bladder filling, accompanied by other symptoms such as increased daytime and night-time frequency, in the absence of proven urinary infection or other obvious pathology.
  • Negative in urine routine test or urine cultivation.
  • Urinating at least 7 times per day or having some urgency or pain (measured on linear analog scales)

Inclusion criteria

  • 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

Exclusion criteria

  • 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;
  • 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.

Treatment and study plan

Electrical ilioinguinal nerve stimulation

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

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.

Primary outcomes

  1. Bladder Pain/ Interstitial Cystitis Symptom Score (BPIC-SS)

    Time frame: 4 weeks

Secondary outcomes

  1. SF-36 questionnaire

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Shanghai Institute of Acupuncture, Moxibustion and Meridian

Other

Registry information

Official study title

A Comparison of the Efficacy of Electrical Ilioinguinal Nerve Stimulation and Intravesical Irrigation in Treating Patients With Bladder Pain Syndrome in Women

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 4, 2016
Registry last updated
Jul 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.