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Completed

NCT Number: NCT02311634

A Comparison of Electrical Pudendal Nerve Stimulation and Transvaginal Electrical Stimulation for Urge Incontinence

The purpose of this study is to determine whether electrical pudendal nerve stimulation is more effective than transvaginal electrical stimulation in treating urge urinary incontinence (UUI).

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Key information

Conditions

Urge 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, Urge 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

Electrical neuromodulation can be used to treat UUI refractory to medication. Electrical neuromodulation therapies include transvaginal or transanal electrical stimulation (TES), percutaneous tibial nerve stimulation (PTNS), sacral neuromodulation (SNM), and pudendal neuromodulation (PNM). TES is easily applicable but is sometimes intolerable for many patients due to discomfort, mucosal injury, and high-intensity stimulation necessary to obtain acceptable outcome. SNM with the InterStim device differs from TES by its continuous stimulation and close nerve contact. It has a high rate of success, but symptoms appear to recur almost immediately after discontinuation of the stimulation, and at least 20 % of patients initially tested do not respond to a test procedure. Its disadvantages included invasiveness, high cost of treatment, high surgical revision rate, device replacement required when battery runs out, and adverse events. PNM with the Interstim device or the Bion device can be used to treat UUI refractory to SNM, but this therapy also has the disadvantages similar to those of SNM. PTNS with needle electrodes is minimally invasive, demonstrates efficacy, and is easily applicable and well tolerated, but PTNS effects diminish over time after the end of treatment.

By combining the advantages of PTNS and PNM and incorporating the technique of deep insertion of long acupuncture needles, the investigators 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). 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 pelvic floor muscle contraction, vaginal pressure and pelvic floor surface electromyogram in our previous study have proved that EPNS can exactly excite PN. The purpose of this study is to compare the efficacies of EPNS versus TES in treating female UUI.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • UUI history
  • Positive pad test result
  • Urodynamic study: A decrease in bladder capacity at the first desire for urination; a decrease in maximum bladder capacity; low compliance bladder

Exclusion criteria

  • UUI that can be relieved by drugs
  • Neurogenic or non-neurogenic UUI
  • Other types of incontinence such as stress incontinence and overflow incontinence

Treatment and study plan

Electrical pudendal nerve stimulation

Device

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.

Transvaginal ES

Device

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

Primary outcomes

  1. A questionnaire to measure the severity of UUI symptoms

    Time frame: three or four weeks

  2. 24-hour urine leakage amount

    Time frame: three or four weeks

Sponsors and collaborators

Lead sponsor

Shanghai Institute of Acupuncture, Moxibustion and Meridian

Other

Registry information

Official study title

A Comparison of Efficacies of Electrical Pudendal Nerve Stimulation Versus Transvaginal Electrical Stimulation in Treating Urge Incontinence

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Dec 8, 2014
Registry last updated
Aug 5, 2016

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.

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