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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Shanghai Institute of Acupuncture, Moxibustion and Meridian
Sponsor:
Information provided by (Responsible Party):
Shanghai Institute of Acupuncture, Moxibustion and Meridian
ClinicalTrials.gov Identifier:
NCT01763762
First received: January 7, 2013
Last updated: September 4, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Stress Urinary Incontinence
Behavioral: Electrical pudendal nerve stimulation
Behavioral: PFM training
Behavioral: Transvaginal ES

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Shanghai Institute of Acupuncture, Moxibustion and Meridian:

Primary Outcome Measures:
  • Stress test [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • A questionnaire to measure the severity of symptoms and the quality of life in SUI women [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Pad test [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: January 2013
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Electrical pudendal nerve stimulation
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
Behavioral: Electrical pudendal nerve stimulation
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.
Active Comparator: PFM training with Transvaginal ES

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.

Behavioral: PFM training
A nerve function reconstruction treatment system (AM1000B; Shenzhen Creative Industry Co.Ltd, China) is used for EMG-biofeedback assisted PFMT.
Behavioral: Transvaginal ES
A neuromuscular stimulation therapy system (PHENIX USB 4,Electronic Concept Lignon Innovation, France) is used for TES

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.

  Eligibility

Ages Eligible for Study:   25 Years to 85 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01763762

Contacts
Contact: Shujing Zhang, Doctor 86-21-64395974 sea_zhang11@126.com
Contact: Siyou Wang, Master 86-21-64395974 wangsiyou1234@163.com

Locations
China
Shanghai research institute of acupuncture and meridian Recruiting
Shanghai, China, 200030
Principal Investigator: Siyou Wang, Master         
Sponsors and Collaborators
Shanghai Institute of Acupuncture, Moxibustion and Meridian
Investigators
Study Chair: Siyou Wang, Master Shanghai research institute of acupuncture and meridian
  More Information

Publications:
Responsible Party: Shanghai Institute of Acupuncture, Moxibustion and Meridian
ClinicalTrials.gov Identifier: NCT01763762     History of Changes
Other Study ID Numbers: ZYSNXD-CC-ZDYJ010
Study First Received: January 7, 2013
Last Updated: September 4, 2013
Health Authority: China: Science and Technology Commission of Shanghai Municipality

Keywords provided by Shanghai Institute of Acupuncture, Moxibustion and Meridian:
Electrical pudendal nerve stimulation
Pelvic floor muscle training
Transvaginal electrical stimulation
Stress urinary incontinence
Comparative study

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Lower Urinary Tract Symptoms
Signs and Symptoms
Urination Disorders
Urologic Diseases
Urological Manifestations

ClinicalTrials.gov processed this record on October 22, 2014