Efficacy of Electrical Pudendal Nerve Stimulation for Patients With Post Prostatectomy Urinary Incontinence

NCT02599831 | Completed DMC

• 1 other identifier: ZYSNXD-CC
• Study Type: interventional
• Target: 96
• 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 plus transanal electrical stimulation in treating post prostatectomy Incontinence.

Conditions

Urinary Incontinence

Keywords

Electrical pudendal nerve stimulation; Pelvic floor muscle training; Transanal electrical stimulation; Post radical prostatectomy incontinence; Comparative study

Outcome Measures

Primary Outcomes (1)

• ICIQ-UI-SF

  International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form

  8 weeks

Secondary Outcomes (1)

• diaper numbers

  8 weeks

Study Arms (2)

Electrical pudendal nerve stimulation

EXPERIMENTAL

Four sacrococcygeal points were selected. Two 0.40Х100 mm needles were inserted perpendicularly to a depth of 80-90 mm 1 cm bilateral to the sacrococcygeal joint, to produce a sensation referred to the root of the penis (perineum) or the anus. Two needles of 0.40Х100 or 125mm were inserted obliquely toward the ischiorectal fossa to a depth of 90 to 110 mm about 1 cm bilateral to the tip of the coccyx, to produce a sensation referred to the root of the penis (or the perineum). Each two ipsilaterally needles were connected to one electrode from a G6805-2Multi-Purpose Health Device (Shanghai Medical Instruments High-Techno, Shanghai, China), with a frequency of 2.5 Hz and an intensity (45\~55 mA). EPNS was given for 60 min a time, 3 times per week for 8 weeks.

Device: Electrical pudendal nerve stimulation

PFM training with Transanal ES

ACTIVE COMPARATOR

Electromyogram BF-assisted PFMT (using a nerve function reconstruction treatment system (AM1000B; Shenzhen Creative Industry Co. Ltd, China) and following TES (using a neuromuscular stimulation therapy system (PHENIX USB4, Electronic Concept Lignon Innovation, France)) at a current intensity of \< 60 mA (as high as possible within the patient's tolerance) and frequencies of 15 Hz and 85 Hz (alternate 3-minute periods of stimulation) were performed by a specially trained therapist, 20 minutes each time, respectively (a total of 40 minutes), 3 times a week for a total of 8 weeks. The patients were also required to conduct 30 maximal high-intensity PFM contractions for 2-6 seconds (with 2-6 seconds rest), 3 sessions every day at home for a total of 8 weeks.

Device: PFM training; Device: Transanal ES

Interventions

Electrical pudendal nerve stimulation DEVICE

Four sacrococcygeal 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 root of the penis (perineum) 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 root of the penis (perineum). 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.

Also known as: G6805-2 Multi-Purpose Health Device

Electrical pudendal nerve stimulation

PFM training DEVICE

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

Also known as: AM1000B (Shenzhen Creative Industry Co.Ltd, China)

PFM training with Transanal ES

Transanal ES DEVICE

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

PFM training with Transanal ES

Eligibility Criteria

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

You may qualify if:

• incontinence at 1 month or more after RP
• ≥2 incontinence episodes a week on baseline 7-day bladder diary
• no residual cancer after RP on pathological examination

You may not qualify if:

• the presence of preoperative incontinence
• treatment with anticholinergics
• urinary tract infection or hematuria
• postvoid residual volume\>100 mL

Sponsors & Collaborators

• Shanghai Institute of Acupuncture, Moxibustion and Meridian: lead

Study Sites (1)

Shanghai research institute of acupuncture and meridian

Shanghai, 200030, China

Location

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

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 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: October 29, 2015
• First Posted: November 9, 2015
• Study Start: November 1, 2015
• Primary Completion: February 1, 2017
• Study Completion: August 1, 2017
• Last Updated: February 27, 2019

Record last verified: 2017-12

Locations

CN (1)