CClinicalTrials.gg
Status unknownNCT03634722Updated Dec 27, 2018

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

An interventional study of PHENIX4-8-8 PLUS in Pelvic Organ Prolapse, sponsored by Peking University People's Hospital. Status unknown at 1 site in China. Open to female participants. Per ClinicalTrials.gov, last updated 2018-12-27.

Sponsored by Peking University People's Hospital · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Dec 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
126
Allocation
Randomized
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Pelvic Organ Prolapse

Keywords

  • transcutaneous electrical nerve stimulation;
03

In context

Prolapse

676 studies on the registry are indexed under Prolapse; 79 are open to participants now.

This study's planned enrollment of 126 is above the median of 74 across 435 interventional studies indexed under Prolapse.

Browse Prolapse studies →

Lead sponsor

Peking University People's Hospital is the lead sponsor of 584 studies on the registry; 233 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Dominant stress urinary incontinence
  • Serious medical problems
  • mental disease
  • infectious disease
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
126 participants (estimated)

Study arms

  • Experimental
    The intervention group

    the transcutaneous electrical nerve stimulation by PHENIX4-8-8 PLUS

    Device: PHENIX4-8-8 PLUS

  • No intervention
    The observational group

    routine nursing

Interventions

  • DevicePHENIX4-8-8 PLUS

    transcutaneous electrical nerve stimulation by PHENIX4-8-8 PLUS

06

What researchers measure

Primary outcomes

  1. the rate of urinary retention

    urinary residual volume

    Time frame: three days after surgery

Secondary outcomes

  1. the rate of urinary incontinence

    according to the 1-h pad test

    Time frame: three days; seven days; one month; three months; six months after surgery

07

Study locations

1 site
  • The Peking University People's Hospital
    Beijing, Beijing 100044, China
08

References and documents

Individual participant data

Plan to share: Yes — The Transcutaneous Electrical Nerve Stimulation can decrease the rate of Lower Urinary Tract Symptoms after Pelvic Reconstructive Surgery

Supporting information: Study protocol, Csr

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 27, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03634722
Lead sponsor
Peking University People's Hospital
Responsible party
Sponsor
First posted
Aug 16, 2018
Start date
Jan 1, 2019 (estimated)
Primary completion
Jan 7, 2019 (estimated)
Completion
Dec 11, 2020 (estimated)
Last update
Dec 27, 2018

Study contacts

Xiuli Sun, professor
Contact
sunxiuli918@126.com
010-88324354
Xiuli Sun
study chair · Beijing Key Laboratory of Female Pelvic Floor Disorders

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion