Pelvic Organ ProlapseNCT03634722
The Efficacy of Transcutaneous Electrical Nerve Stimulation on LUTS: One Prospective Study.
A study testing PHENIX4-8-8 PLUS in people with Pelvic Organ Prolapse, run by Peking University People's Hospital at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- PHENIX4-8-8 PLUS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 11 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- severe pelvic organ prolapse(POP-Q:3/4 stage)
- accept pelvic reconstructive surgery
Who cannot join
- Dominant stress urinary incontinence
- Serious medical problems
- mental disease
- infectious disease
Trial locations and contacts
1 site in 1 country.
China1 site
The Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Xiuli Sun, professor, 010-88324354, sunxiuli918@126.com
Tingting Cao, doctor, 010-88324354, zzucaotingting@163.com
About this study
Official title: Beijing Key Laboratory of Female Pelvic Floor Disorders of Peking University People's Hospital
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.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- PHENIX4-8-8 PLUS
- Keywords
- transcutaneous electrical nerve stimulation;
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PHENIX4-8-8 PLUSDevice
transcutaneous electrical nerve stimulation by PHENIX4-8-8 PLUS
| Study group | Role | What they receive |
|---|---|---|
| The intervention group | Experimental | the transcutaneous electrical nerve stimulation by PHENIX4-8-8 PLUS Receives: Device: PHENIX4-8-8 PLUS |
| The observational group | No intervention | routine nursing |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of urinary retention
urinary residual volume
Measured: three days after surgery
Secondary outcomes (1)
the rate of urinary incontinence
according to the 1-h pad test
Measured: three days; seven days; one month; three months; six months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study start1 Jan 2019 (estimated)
- Primary completion7 Jan 2019 (estimated)
- Study completion11 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- the transcutaneous electrical nerve stimulation by PHENIX4-8-8 PLUS
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiuli Sun, Study chair, Beijing Key Laboratory of Female Pelvic Floor Disorders
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03634722
- Sponsor's protocol ID
- PKUPH2
- Status last verified
- Dec 2018
- First submitted
- 23 Jul 2018
- Last updated
- 27 Dec 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Transcutaneous Electrical Nerve Stimulation can decrease the rate of Lower Urinary Tract Symptoms after Pelvic Reconstructive Surgery
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beijing Key Laboratory of Female Pelvic Floor Disorders of Peking University People's Hospital
- ClinicalTrials.gov ID
- NCT03634722
- Acronym / sponsor ID
- PKUPH2
- Conditions
- Pelvic Organ Prolapse
- Keywords
- transcutaneous electrical nerve stimulation;
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- 7 Jan 2019 (estimated)
- Study completion
- 11 Dec 2020 (estimated)
- First posted
- 16 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- the transcutaneous electrical nerve stimulation by PHENIX4-8-8 PLUS
| Arm | Type | Receives |
|---|---|---|
| The intervention group | Experimental | Device: PHENIX4-8-8 PLUSthe transcutaneous electrical nerve stimulation by PHENIX4-8-8 PLUS |
| The observational group | No intervention | –routine nursing |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- severe pelvic organ prolapse(POP-Q:3/4 stage)
- accept pelvic reconstructive surgery
Key exclusion criteria (4 listed)
- Dominant stress urinary incontinence
- Serious medical problems
- mental disease
- infectious disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PHENIX4-8-8 PLUStranscutaneous electrical nerve stimulation by PHENIX4-8-8 PLUS | Device | The intervention group |
Primary outcome
the rate of urinary retention
Time frame: three days after surgery
urinary residual volume
1 secondary outcome
the rate of urinary incontinence
Time frame: three days; seven days; one month; three months; six months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2018.
- Individual participant dataSharing planned: Yes. The Transcutaneous Electrical Nerve Stimulation can decrease the rate of Lower Urinary Tract Symptoms after Pelvic Reconstructive Surgery
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiuli Sun study chair
Beijing Key Laboratory of Female Pelvic Floor Disorders
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PHENIX4-8-8 PLUS in people with Pelvic Organ Prolapse, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiuli Sun, professor (010-88324354, sunxiuli918@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the rate of urinary retention (time frame: three days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2018.