Skip to main content
OpenTrials
Completed

NCT Number: NCT01763762

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

25 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai research institute of acupuncture and meridian

Shanghai, 200030, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

PFM training

Behavioral

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

Transvaginal ES

Behavioral

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

Primary outcomes

  1. Stress test

    Time frame: 12 weeks

Secondary outcomes

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

    Time frame: 12 weeks

Other outcomes

  1. Pad test

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Shanghai Institute of Acupuncture, Moxibustion and Meridian

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 9, 2013
Registry last updated
Nov 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.