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

Shanghai Institute of Acupuncture, Moxibustion and Meridian

Status: Completed

Conditions: Stress Urinary Incontinence

Treatments: Behavioral: Transvaginal ES; Behavioral: PFM training; Behavioral: Electrical pudendal nerve stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT01763762

ZYSNXD-CC-ZDYJ010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: Female

Ages: 25 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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42 participants in 2 patient groups

Electrical pudendal nerve stimulation

Experimental group

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

Treatment:

Behavioral: Electrical pudendal nerve stimulation

PFM training with Transvaginal ES

Active Comparator group

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.

Treatment:

Behavioral: PFM training

Behavioral: Transvaginal ES