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

Not Applicable

Completed

Conditions: Stress Urinary Incontinence

Interventions: Behavioral: Electrical pudendal nerve stimulation
Behavioral: PFM training
Behavioral: Transvaginal ES

Registration Number: NCT01763762

Lead Sponsor: Shanghai Institute of Acupuncture, Moxibustion and Meridian

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 42

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Electrical pudendal nerve stimulation	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
PFM training with Transvaginal ES	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.
PFM training with Transvaginal ES	PFM training	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.

Primary Outcome Measures

Name	Time	Method
Stress test	12 weeks

Secondary Outcome Measures

Name	Time	Method
A questionnaire to measure the severity of symptoms and the quality of life in SUI women	12 weeks

Trial Locations

Locations (1): Shanghai research institute of acupuncture and meridian
🇨🇳
Shanghai, China