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A Comparison of Electrical Pudendal Nerve Stimulation and Pelvic Floor Muscle Training for Female Stress Incontinence

Primary Purpose

Stress Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Electrical pudendal nerve stimulation
PFM training
Transvaginal ES
Sponsored by
Shanghai Institute of Acupuncture, Moxibustion and Meridian
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring Electrical pudendal nerve stimulation, Pelvic floor muscle training, Transvaginal electrical stimulation, Stress urinary incontinence, Comparative study

Eligibility Criteria

25 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • SUI history
  • Positive stress test result
  • Urodynamically confirmed SUI
  • Postvoid residual urine volume <50ml

Exclusion Criteria:

  • Urge incontinence (overactive bladder or detrusor overactivity incontinence)
  • Neurogenic bladder

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

PFM training with Transvaginal ES

Arm Description

At a frequency of 2.5 Hz and an intensity (45~55 mA) as high as the patient can tolerate without discomfort; 60 minutes three times a week for a total of four weeks

PFM training: EMG-biofeedback assisted PFMT was performed by specially trained therapists, 20 min three times a week for a total of four weeks. Patients conduct 30 maximal high intensity PFM contractions for 2-6 sec (with 2-6 sec rest), three sessions a day at home for a total of four weeks. Transvaginal ES: At a current intensity of < 60 mA (as high as possible to get a contraction) and frequencies of 15 Hz and 85 Hz (alternate 3-min periods of stimulation); 20 min three times a week for a total of four weeks.

Outcomes

Primary Outcome Measures

Stress test

Secondary Outcome Measures

A questionnaire to measure the severity of symptoms and the quality of life in SUI women

Full Information

First Posted
January 7, 2013
Last Updated
November 19, 2014
Sponsor
Shanghai Institute of Acupuncture, Moxibustion and Meridian
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1. Study Identification

Unique Protocol Identification Number
NCT01763762
Brief Title
A Comparison of Electrical Pudendal Nerve Stimulation and Pelvic Floor Muscle Training for Female Stress Incontinence
Official Title
A Comparison of the Efficacy of Electrical Pudendal Nerve Stimulation to Pelvic Floor Muscle Training With Transvaginal Electrical Stimulation in Treating Female Stress Incontinence
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
February 2014 (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 pelvic floor muscle training with Transvaginal electrical stimulation in treating female stress incontinence.
Detailed Description
Conservative therapy could be considered a choice of treatment for stress urinary incontinence (SUI) as it seems to have no side effects and causes significant and long-term improvement in symptoms. Pelvic floor muscle training (PFMT) and electrical stimulation are two commonly used forms of conservative treatment for SUI. PFMT improves the structural support of the pelvis. However, many patients-especially women-have difficulty identifying and isolating their pelvic floor muscles (PFM) and are unable to perform the exercise effectively. Furthermore, patients who can identify the PFM often find that the required daily exercise routine is burdensome. Hence, the primary disadvantage of PFMT is lack of long-term patient compliance. Electrical stimulation (ES) is a non-invasive, passive treatment that produces a muscle contraction. Transvaginal electrical stimulation (TES) has almost no side-effects and patient compliance in published reports is 70-85%. TES will result in PFM contraction by indirect nerve stimulation, mainly by polysynaptic reflex responses. The indirect stimulation and reflexive contraction may be the reason why the effect of electrical stimulation is not as good as that of PFMT when performed correctly. By combining the advantages of PFMT and TES and incorporating the technique of deep insertion of long acupuncture needles, we 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) and contract the PFM. 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 PFM contraction, vaginal pressure and pelvic floor surface electromyogram in our previous study have proved that EPNS can exactly excite PN,contract the PFM and simulate PFMT. Our previous study has also proved that EPNS has a good therapeutic effect on female SUI. The purpose of this study is to compare the efficacy of EPNS to PFMT with TES in treating female SUI.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
Keywords
Electrical pudendal nerve stimulation, Pelvic floor muscle training, Transvaginal electrical stimulation, Stress 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
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Electrical pudendal nerve stimulation
Arm Type
Experimental
Arm Description
At a frequency of 2.5 Hz and an intensity (45~55 mA) as high as the patient can tolerate without discomfort; 60 minutes three times a week for a total of four weeks
Arm Title
PFM training with Transvaginal ES
Arm Type
Active Comparator
Arm Description
PFM training: EMG-biofeedback assisted PFMT was performed by specially trained therapists, 20 min three times a week for a total of four weeks. Patients conduct 30 maximal high intensity PFM contractions for 2-6 sec (with 2-6 sec rest), three sessions a day at home for a total of four weeks. Transvaginal ES: At a current intensity of < 60 mA (as high as possible to get a contraction) and frequencies of 15 Hz and 85 Hz (alternate 3-min periods of stimulation); 20 min three times a week for a total of four weeks.
Intervention Type
Behavioral
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
Behavioral
Intervention Name(s)
PFM training
Intervention Description
A nerve function reconstruction treatment system (AM1000B; Shenzhen Creative Industry Co.Ltd, China) is used for EMG-biofeedback assisted PFMT.
Intervention Type
Behavioral
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
Stress test
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
A questionnaire to measure the severity of symptoms and the quality of life in SUI women
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Pad test
Time Frame
12 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: SUI history Positive stress test result Urodynamically confirmed SUI Postvoid residual urine volume <50ml Exclusion Criteria: Urge incontinence (overactive bladder or detrusor overactivity incontinence) Neurogenic bladder
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
22417077
Citation
Wang S, Zhang S. Simultaneous perineal ultrasound and vaginal pressure measurement prove the action of electrical pudendal nerve stimulation in treating female stress incontinence. BJU Int. 2012 Nov;110(9):1338-43. doi: 10.1111/j.1464-410X.2012.11029.x. Epub 2012 Mar 15.
Results Reference
background
PubMed Identifier
26921645
Citation
Wang S, Lv J, Feng X, Wang G, Lv T. Efficacy of Electrical Pudendal Nerve Stimulation in Treating Female Stress Incontinence. Urology. 2016 May;91:64-9. doi: 10.1016/j.urology.2016.02.027. Epub 2016 Feb 24.
Results Reference
derived

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A Comparison of Electrical Pudendal Nerve Stimulation and Pelvic Floor Muscle Training for Female Stress Incontinence

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