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

Primary Purpose

Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Electrical pudendal nerve stimulation
PFM training
Transanal ES
Sponsored by
Shanghai Institute of Acupuncture, Moxibustion and Meridian
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence focused on measuring Electrical pudendal nerve stimulation, Pelvic floor muscle training, Transanal electrical stimulation, Post radical prostatectomy incontinence, Comparative study

Eligibility Criteria

25 Years - 85 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sites / Locations

  • Shanghai research institute of acupuncture and meridian

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Electrical pudendal nerve stimulation

PFM training with Transanal ES

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

ICIQ-UI-SF
International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form

Secondary Outcome Measures

diaper numbers
none, 1-3 per week, 4-6 per week, 1-4 per day and more than 4 per day are scored 0, 1, 2, 3 and 4 respectively

Full Information

First Posted
October 29, 2015
Last Updated
February 25, 2019
Sponsor
Shanghai Institute of Acupuncture, Moxibustion and Meridian
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1. Study Identification

Unique Protocol Identification Number
NCT02599831
Brief Title
Efficacy of Electrical Pudendal Nerve Stimulation for Patients With Post Prostatectomy Urinary Incontinence
Official Title
Efficacy of Electrical Pudendal Nerve Stimulation for Patients With Post Prostatectomy Urinary Incontinence
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Institute of Acupuncture, Moxibustion and Meridian

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Conservative therapy could be considered a choice of treatment for stress urinary incontinence (SUI) as it seems to have no side effect 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 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. Transanal electrical stimulation (TES) has little side-effect, and the patient compliance is 70-85% in published reports. TES results 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. Our previous study showed that EPNS had a better therapeutic effect on female SUI as compared with PFMT + TES. 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 and induce PFM contraction in female SUI patients. However, EPNS has also shown satisfactory effect in male patients with SUI problems. The purpose of this study is to compare the efficacy of EPNS to PFMT + TES in treating male SUI.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
Keywords
Electrical pudendal nerve stimulation, Pelvic floor muscle training, Transanal electrical stimulation, Post radical prostatectomy incontinence, Comparative study

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Electrical pudendal nerve stimulation
Arm Type
Experimental
Arm Description
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.
Arm Title
PFM training with Transanal ES
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Electrical pudendal nerve stimulation
Other Intervention Name(s)
G6805-2 Multi-Purpose Health Device
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
PFM training
Other Intervention Name(s)
AM1000B (Shenzhen Creative Industry Co.Ltd, China)
Intervention Description
A nerve function reconstruction treatment system (AM1000B; Shenzhen Creative Industry Co.Ltd, China) is used for EMG-biofeedback assisted PFMT.
Intervention Type
Device
Intervention Name(s)
Transanal ES
Intervention Description
A neuromuscular stimulation therapy system (PHENIX USB 4,Electronic Concept Lignon Innovation, France) is used for TES
Primary Outcome Measure Information:
Title
ICIQ-UI-SF
Description
International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
diaper numbers
Description
none, 1-3 per week, 4-6 per week, 1-4 per day and more than 4 per day are scored 0, 1, 2, 3 and 4 respectively
Time Frame
8 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: the presence of preoperative incontinence treatment with anticholinergics urinary tract infection or hematuria postvoid residual volume>100 mL
Facility Information:
Facility Name
Shanghai research institute of acupuncture and meridian
City
Shanghai
ZIP/Postal Code
200030
Country
China

12. IPD Sharing Statement

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

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