A Comparison of Electrical Pudendal Nerve Stimulation and Transvaginal Electrical Stimulation for Urge Incontinence
Primary Purpose
Urge Urinary Incontinence
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Electrical pudendal nerve stimulation
Transvaginal ES
Sponsored by
About this trial
This is an interventional treatment trial for Urge Urinary Incontinence focused on measuring Electrical pudendal nerve stimulation, Transvaginal electrical stimulation, Urge urinary incontinence, Comparative study
Eligibility Criteria
Inclusion Criteria:
- UUI history
- Positive pad test result
- Urodynamic study: A decrease in bladder capacity at the first desire for urination; a decrease in maximum bladder capacity; low compliance bladder
Exclusion Criteria:
- UUI that can be relieved by drugs
- Neurogenic or non-neurogenic UUI
- Other types of incontinence such as stress incontinence and overflow incontinence
Sites / Locations
- Shanghai research institute of acupuncture and meridian
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Electrical pudendal nerve stimulation
Transvaginal ES
Arm Description
At a frequency of 2.0 Hz and a moderate intensity (25~35 mA); 60 minutes three times a week for a total of three weeks
At a current intensity of < 60 mA (in 5% increments from 0 mA to the intensity that is sensed without obvious discomfort) and frequencies of 12.5 to 30 Hz, 45 min three times a week for a total of four weeks.
Outcomes
Primary Outcome Measures
A questionnaire to measure the severity of UUI symptoms
24-hour urine leakage amount
Secondary Outcome Measures
Full Information
NCT ID
NCT02311634
First Posted
November 19, 2014
Last Updated
August 3, 2016
Sponsor
Shanghai Institute of Acupuncture, Moxibustion and Meridian
1. Study Identification
Unique Protocol Identification Number
NCT02311634
Brief Title
A Comparison of Electrical Pudendal Nerve Stimulation and Transvaginal Electrical Stimulation for Urge Incontinence
Official Title
A Comparison of Efficacies of Electrical Pudendal Nerve Stimulation Versus Transvaginal Electrical Stimulation in Treating Urge Incontinence
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Institute of Acupuncture, Moxibustion and Meridian
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine whether electrical pudendal nerve stimulation is more effective than transvaginal electrical stimulation in treating urge urinary incontinence (UUI).
Detailed Description
Electrical neuromodulation can be used to treat UUI refractory to medication. Electrical neuromodulation therapies include transvaginal or transanal electrical stimulation (TES), percutaneous tibial nerve stimulation (PTNS), sacral neuromodulation (SNM), and pudendal neuromodulation (PNM). TES is easily applicable but is sometimes intolerable for many patients due to discomfort, mucosal injury, and high-intensity stimulation necessary to obtain acceptable outcome. SNM with the InterStim device differs from TES by its continuous stimulation and close nerve contact. It has a high rate of success, but symptoms appear to recur almost immediately after discontinuation of the stimulation, and at least 20 % of patients initially tested do not respond to a test procedure. Its disadvantages included invasiveness, high cost of treatment, high surgical revision rate, device replacement required when battery runs out, and adverse events. PNM with the Interstim device or the Bion device can be used to treat UUI refractory to SNM, but this therapy also has the disadvantages similar to those of SNM. PTNS with needle electrodes is minimally invasive, demonstrates efficacy, and is easily applicable and well tolerated, but PTNS effects diminish over time after the end of treatment.
By combining the advantages of PTNS and PNM and incorporating the technique of deep insertion of long acupuncture needles, the investigators developed electrical pudendal nerve stimulation (EPNS). 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 (PN). 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 pelvic floor muscle contraction, vaginal pressure and pelvic floor surface electromyogram in our previous study have proved that EPNS can exactly excite PN. The purpose of this study is to compare the efficacies of EPNS versus TES in treating female UUI.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urge Urinary Incontinence
Keywords
Electrical pudendal nerve stimulation, Transvaginal electrical stimulation, Urge urinary incontinence, Comparative study
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Electrical pudendal nerve stimulation
Arm Type
Experimental
Arm Description
At a frequency of 2.0 Hz and a moderate intensity (25~35 mA); 60 minutes three times a week for a total of three weeks
Arm Title
Transvaginal ES
Arm Type
Active Comparator
Arm Description
At a current intensity of < 60 mA (in 5% increments from 0 mA to the intensity that is sensed without obvious discomfort) and frequencies of 12.5 to 30 Hz, 45 min three times a week for a total of four weeks.
Intervention Type
Device
Intervention Name(s)
Electrical pudendal nerve stimulation
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Transvaginal ES
Intervention Description
A neuromuscular stimulation therapy system (PHENIX USB 4,Electronic Concept Lignon Innovation, France) is used for TES
Primary Outcome Measure Information:
Title
A questionnaire to measure the severity of UUI symptoms
Time Frame
three or four weeks
Title
24-hour urine leakage amount
Time Frame
three or four weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
UUI history
Positive pad test result
Urodynamic study: A decrease in bladder capacity at the first desire for urination; a decrease in maximum bladder capacity; low compliance bladder
Exclusion Criteria:
UUI that can be relieved by drugs
Neurogenic or non-neurogenic UUI
Other types of incontinence such as stress incontinence and overflow incontinence
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Siyou Wang, Master
Organizational Affiliation
Shanghai research institute of acupuncture and meridian
Official's Role
Study Chair
Facility Information:
Facility Name
Shanghai research institute of acupuncture and meridian
City
Shanghai
ZIP/Postal Code
200030
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
24091564
Citation
Wang S, Zhang S, Zhao L. Long-term efficacy of electrical pudendal nerve stimulation for urgency-frequency syndrome in women. Int Urogynecol J. 2014 Mar;25(3):397-402. doi: 10.1007/s00192-013-2223-7. Epub 2013 Oct 3.
Results Reference
result
Learn more about this trial
A Comparison of Electrical Pudendal Nerve Stimulation and Transvaginal Electrical Stimulation for Urge Incontinence
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