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

NCT01763762 | Completed DMC

• 1 other identifier: ZYSNXD-CC-ZDYJ010
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Urinary Incontinence

Keywords

Electrical pudendal nerve stimulation; Pelvic floor muscle training; Transvaginal electrical stimulation; Stress urinary incontinence; Comparative study

Outcome Measures

Primary Outcomes (1)

• Stress test

  12 weeks

Secondary Outcomes (1)

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

  12 weeks

Other Outcomes (1)

• Pad test

  12 weeks

Study Arms (2)

Electrical pudendal nerve stimulation

EXPERIMENTAL

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

PFM training with Transvaginal ES

ACTIVE COMPARATOR

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; Behavioral: Transvaginal ES

Interventions

Electrical pudendal nerve stimulation BEHAVIORAL

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.

Electrical pudendal nerve stimulation

PFM training BEHAVIORAL

A nerve function reconstruction treatment system (AM1000B; Shenzhen Creative Industry Co.Ltd, China) is used for EMG-biofeedback assisted PFMT.

PFM training with Transvaginal ES

Transvaginal ES BEHAVIORAL

A neuromuscular stimulation therapy system (PHENIX USB 4，Electronic Concept Lignon Innovation, France) is used for TES

PFM training with Transvaginal ES

Eligibility Criteria

• Age: 25 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai Institute of Acupuncture, Moxibustion and Meridian: lead

Study Sites (1)

Shanghai research institute of acupuncture and meridian

Shanghai, 200030, China

Location

Related Publications (2)

• 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.

  PMID: 22417077 BACKGROUND

• 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.

  PMID: 26921645 DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Siyou Wang, Master

  Shanghai research institute of acupuncture and meridian

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2013
• First Posted: January 9, 2013
• Study Start: January 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: February 1, 2014
• Last Updated: November 20, 2014

Record last verified: 2013-09

Locations

CN (1)