The Efficacy of Transcutaneous Electrical Nerve Stimulation on LUTS: One Prospective Study.

• Sponsor: Peking University People's Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03634722
• Collaborator: (none)
• Enrollment: 126
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 23.3
• Patients Per Site Per Month: 5.4

Study Details

Study Description

Brief Summary

The study is a prospective study at a single institution. Investigators create strict inclusion and exclusion criteria, selecting 126 patients who undergo the pelvic reconstructive surgery. 63 patients in the intervention group accept 10 times of the transcutaneous electrical nerve stimulation.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Organ Prolapse	Device: PHENIX4-8-8 PLUS	N/A

Detailed Description

All the patients have severe pelvic organ prolapse and undergo the pelvic reconstructive surgery. Investigators evaluate all patients' lower urinary tract symptoms, quality of life score, overactive bladder questionnaire, maximal rate and residual urine volume, at 1, 3, 6 and 12 months after the surgery.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 126 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: the transcutaneous electrical nerve stimulation by PHENIX4-8-8 PLUSthe transcutaneous electrical nerve stimulation by PHENIX4-8-8 PLUS
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: Beijing Key Laboratory of Female Pelvic Floor Disorders of Peking University People's Hospital
• Anticipated Study Start Date: Jan 1, 2019
• Anticipated Primary Completion Date: Jan 7, 2019
• Anticipated Study Completion Date: Dec 11, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: The intervention group the transcutaneous electrical nerve stimulation by PHENIX4-8-8 PLUS	Device: PHENIX4-8-8 PLUS; transcutaneous electrical nerve stimulation by PHENIX4-8-8 PLUS
No Intervention: The observational group routine nursing

Outcome Measures

Primary Outcome Measures

1. the rate of urinary retention [three days after surgery]

   urinary residual volume

Secondary Outcome Measures

1. the rate of urinary incontinence [three days; seven days; one month; three months; six months after surgery]

   according to the 1-h pad test

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• severe pelvic organ prolapse(POP-Q:3/4 stage)

• accept pelvic reconstructive surgery

Exclusion Criteria:

• Dominant stress urinary incontinence

• Serious medical problems

• mental disease

• infectious disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Peking University People's Hospital	Beijing	Beijing	China	100044

Sponsors and Collaborators

• Peking University People's Hospital

Investigators

• Study Chair: Xiuli Sun, Beijing Key Laboratory of Female Pelvic Floor Disorders

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Peking University People's Hospital
• ClinicalTrials.gov Identifier: NCT03634722
• Other Study ID Numbers: PKUPH2
• First Posted: Aug 16, 2018
• Last Update Posted: Dec 27, 2018
• Last Verified: Dec 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Peking University People's Hospital: transcutaneous electrical nerve stimulation;
• Additional relevant MeSH terms: Prolapse; Pelvic Organ Prolapse

Study Results

No Results Posted as of Dec 27, 2018