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

Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02599831
• Other study ID #: ZYSNXD-CC
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: August 2017

Study information

• Verified date: December 2017
• Source: Shanghai Institute of Acupuncture, Moxibustion and Meridian
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: August 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 25 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence

Intervention

Device:
• Electrical pudendal nerve stimulation
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 ? 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 ? 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.
• PFM training
A nerve function reconstruction treatment system (AM1000B; Shenzhen Creative Industry Co.Ltd, China) is used for EMG-biofeedback assisted PFMT.
• Transanal ES
A neuromuscular stimulation therapy system (PHENIX USB 4,Electronic Concept Lignon Innovation, France) is used for TES

Locations

Country	Name	City	State
China	Shanghai research institute of acupuncture and meridian	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Institute of Acupuncture, Moxibustion and Meridian

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ICIQ-UI-SF	International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form	8 weeks
Secondary	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	8 weeks