Urinary Incontinence Following Surgical ProcedureNCT06130306
A PSM Analysis to Evaluate Electrical Pudendal Nerve Stimulation for PPI
An observational study of Urinary Incontinence Following Surgical Procedure, run by Shanghai Institute of Acupuncture, Moxibustion and Meridian at 1 site in China.
Trial summary
The goal of this propensity score matching study is to compare the posttreatment outcomes of post-radical prostatectomy Incontinence patients undergoing either electrical pudendal nerve stimulation or pelvic floor muscle training combined with transanal electrical stimulation. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Urinary Incontinence Following Surgical Procedure
- What is being tested?
- electrical pudendal nerve stimulation and pelvic floor muscle training combined with transanal electrical stimulation
- Type of treatment
- Surgery or procedure
- How many people
- 389 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2023to 31 Dec 2024
- Phase
- Observational
- 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 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged between 18-80 with post-radical prostatectomy incontinence treated at 3 tertiary academic medical centers between 2012 and 2020 were retrieved.
Who may be able to join
- Onset of urinary incontinence at least 1 month post-RP
- Minimum two documented incontinence episodes per week in a 7-day bladder diary
- Pathological confirmation of no residual cancer post-RP
Who cannot join
- High pathological risk factors (e.g., lymph node metastasis, resection margin involvement, bulky tumors)
- Preoperative incontinence
- Prior anticholinergic treatment
- Urinary tract infection or hematuria
- Postvoid residual volume exceeding 100 ml (determined by bladder ultrasound)
- Neurological disorders
- Urethral stricture
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai research institute of acupuncture and meridian
Shanghai, 200030
About this study
Official title: Electrical Pudendal Nerve Stimulation Versus Pelvic Floor Muscle Training Plus Transanal Electrical Stimulation for Post-Radical Prostatectomy Incontinence: A Propensity Score Matching Analysis
The goal of this propensity score matching study is to compare the posttreatment outcomes of post-radical prostatectomy Incontinence patients undergoing either electrical pudendal nerve stimulation or pelvic floor muscle training combined with transanal electrical stimulation.
Read the detailed description
Prostate cancer is the predominant form of cancer in older males. Radical prostatectomy (RP) is the sole treatment that enhances both overall survival and cancer-specific survival.Urinary incontinence remains a major morbidity associated with this procedure, greatly affecting patient satisfaction following RP. Extant research underscores the efficacy of pelvic floor muscle training (PFMT) in improving the strength and function of specific pelvic floor muscles, causing hypertrophy of peri-urethral striated muscles, thereby increasing the external mechanical pressure on the urethra. Another promising physiotherapy for post-radical prostatectomy incontinence (PPI) is electrical pudendal nerve stimulation (EPNS). An increasing body of research focuses on comparing continence restoration outcomes between PFMT and various electrical stimulations. However, such studies encompass cases with multiple pathological characteristics, and the reported data might not be considered representative or applicable to other populations due to overlooked confounding factors or selection bias. Thus, the investigators intend to conduct a propensity score matching (PSM) study aiming to compare the posttreatment outcomes of patients undergoing either EPNS or PFMT combined with TES, while ensuring a well-balanced control for confounding factor.
- Being tested
- electrical pudendal nerve stimulation, pelvic floor muscle training combined with transanal electrical stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electrical pudendal nerve stimulationProcedure or surgery
The patient was positioned prone post-micturition. Long needles (0.40 Х 100 mm) were inserted perpendicularly, 1 cm bilateral to the sacrococcygeal joint, to a depth of 80-90 mm, eliciting sensations referred to the urethra or anus. The lower points, 1 cm bilateral to the coccyx tip, received oblique insertion of longer needles (0.40 Х 125 mm) toward the ischiorectal fossa (90-110 mm depth), inducing sensations precisely to the urethra. Connected to a G6805-2 Multi-Purpose Health Device, the ipsilateral needles created an electric loop, with the upper as anode and lower as cathode. Direct electrical stimulation (2.5 Hz, 25~35 mA) for 45 minutes targeted the pudendal nerve, thrice weekly for a minimum of 8 weeks. The treatment plan remains ongoing until the patient opts to discontinue voluntarily.
pelvic floor muscle training combined with transanal electrical stimulationProcedure or surgery
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 USB 4, Electronic Concept Lignon Innovation, France)) at a current intensity of < 60 mA (as high as possible to get a PFM contraction) 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 also conducted 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. If the patient is willing, the treatment plan can continue until the patient voluntarily decides to stop.
| Study group | Role | What they receive |
|---|---|---|
| Electrical Pudendal Nerve Stimulation Group | Electrical Pudendal Nerve Stimulation Receives: Procedure: electrical pudendal nerve stimulation | |
| Pelvic Floor Muscle Training Group | Pelvic Floor Muscle Training Plus Transanal Electrical Stimulation Receives: Procedure: pelvic floor muscle training combined with transanal electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Consultation on Incontinence Questionnaire-short form score (ICIQ-SF)
The International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) is a validated and widely used questionnaire to assess and measure the impact of urinary incontinence on an individual's quality of life. This part includes a set of simple questions related to urinary incontinence symptoms, which the individual answers. The questions address the type and frequency of incontinence episodes, as well as their impact on daily life. The higher the score, the more severe the condition.
Measured: T0 (baseline); T1 (day after 24th treatment); T2 (day after 36th treatment); T3 (day after 48th treatment); T4 (day after 60th treatment); T5 (day after 72nd treatment).
Secondary outcomes (1)
Pad-counting Score
the number of urine pad consumption in 24 hours.The higher the score, the more severe the condition.
Measured: T0 (baseline); T1 (day after 24th treatment); T2 (day after 36th treatment); T3 (day after 48th treatment); T4 (day after 60th treatment); T5 (day after 72nd treatment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study start1 Dec 2023
- Primary completion30 Nov 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary Incontinence Following Surgical ProcedureStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 389 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Institute of Acupuncture, Moxibustion and Meridian
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Pudong Hospital of Traditional Chinese Medicine
- Responsible party
- Sponsor
- Investigators
- Siyou Wang, Principal investigator, Shanghai research institute of acupuncture and meridian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06130306
- Sponsor's protocol ID
- PWRq2022-47
- Status last verified
- Aug 2023
- First submitted
- 5 Nov 2023
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If necessary, contact Dr. Siyou Wang to provide the original data.
Publications
Li T, Wang S, Chen Q, Lv T, Huang Z. Electrical pudendal nerve stimulation versus pelvic floor muscle training with transrectal electrical stimulation for post-radical prostatectomy incontinence: a cohort study. Sci Rep. 2025 Nov 24;15(1):41603. doi: 10.1038/s41598-025-25567-3.
PubMed 41286037
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Pudendal Nerve Stimulation Versus Pelvic Floor Muscle Training Plus Transanal Electrical Stimulation for Post-Radical Prostatectomy Incontinence: A Propensity Score Matching Analysis
- ClinicalTrials.gov ID
- NCT06130306
- Acronym / sponsor ID
- PWRq2022-47
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 389 participants (actual)
- Lead sponsor
- Shanghai Institute of Acupuncture, Moxibustion and MeridianUniversity, hospital or other
- Collaborators
- Shanghai Pudong Hospital of Traditional Chinese Medicine
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 14 Nov 2023 (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 goal of this propensity score matching study is to compare the posttreatment outcomes of post-radical prostatectomy Incontinence patients undergoing either electrical pudendal nerve stimulation or pelvic floor muscle training combined with transanal electrical stimulation.
Detailed description
Prostate cancer is the predominant form of cancer in older males. Radical prostatectomy (RP) is the sole treatment that enhances both overall survival and cancer-specific survival.Urinary incontinence remains a major morbidity associated with this procedure, greatly affecting patient satisfaction following RP. Extant research underscores the efficacy of pelvic floor muscle training (PFMT) in improving the strength and function of specific pelvic floor muscles, causing hypertrophy of peri-urethral striated muscles, thereby increasing the external mechanical pressure on the urethra. Another promising physiotherapy for post-radical prostatectomy incontinence (PPI) is electrical pudendal nerve stimulation (EPNS). An increasing body of research focuses on comparing continence restoration outcomes between PFMT and various electrical stimulations. However, such studies encompass cases with multiple pathological characteristics, and the reported data might not be considered representative or applicable to other populations due to overlooked confounding factors or selection bias. Thus, the investigators intend to conduct a propensity score matching (PSM) study aiming to compare the posttreatment outcomes of patients undergoing either EPNS or PFMT combined with TES, while ensuring a well-balanced control for confounding factor.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electrical Pudendal Nerve Stimulation Group | – | Procedure: electrical pudendal nerve stimulationElectrical Pudendal Nerve Stimulation |
| Pelvic Floor Muscle Training Group | – | Procedure: pelvic floor muscle training combined with transanal electrical stimulationPelvic Floor Muscle Training Plus Transanal Electrical Stimulation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged between 18-80 with post-radical prostatectomy incontinence treated at 3 tertiary academic medical centers between 2012 and 2020 were retrieved.
Key inclusion criteria (3 listed)
- Onset of urinary incontinence at least 1 month post-RP
- Minimum two documented incontinence episodes per week in a 7-day bladder diary
- Pathological confirmation of no residual cancer post-RP
Key exclusion criteria (7 listed)
- High pathological risk factors (e.g., lymph node metastasis, resection margin involvement, bulky tumors)
- Preoperative incontinence
- Prior anticholinergic treatment
- Urinary tract infection or hematuria
- Postvoid residual volume exceeding 100 ml (determined by bladder ultrasound)
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 |
|---|---|---|
| electrical pudendal nerve stimulationThe patient was positioned prone post-micturition. Long needles (0.40 Х 100 mm) were inserted perpendicularly, 1 cm bilateral to the sacrococcygeal joint, to a depth of 80-90 mm, eliciting sensations referred to the urethra or anus. The lower points, 1 cm bilateral to the coccyx tip, received oblique insertion of longer needles (0.40 Х 125 mm) toward the ischiorectal fossa (90-110 mm depth), inducing sensations precisely to the urethra. Connected to a G6805-2 Multi-Purpose Health Device, the ipsilateral needles created an electric loop, with the upper as anode and lower as cathode. Direct electrical stimulation (2.5 Hz, 25~35 mA) for 45 minutes targeted the pudendal nerve, thrice weekly for a minimum of 8 weeks. The treatment plan remains ongoing until the patient opts to discontinue voluntarily. | Procedure or surgery | Electrical Pudendal Nerve Stimulation Group |
| pelvic floor muscle training combined with transanal electrical stimulationElectromyogram 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 USB 4, Electronic Concept Lignon Innovation, France)) at a current intensity of < 60 mA (as high as possible to get a PFM contraction) 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 also conducted 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. If the patient is willing, the treatment plan can continue until the patient voluntarily decides to stop. | Procedure or surgery | Pelvic Floor Muscle Training Group |
Primary outcome
International Consultation on Incontinence Questionnaire-short form score (ICIQ-SF)
Time frame: T0 (baseline); T1 (day after 24th treatment); T2 (day after 36th treatment); T3 (day after 48th treatment); T4 (day after 60th treatment); T5 (day after 72nd treatment).
The International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) is a validated and widely used questionnaire to assess and measure the impact of urinary incontinence on an individual's quality of life. This part includes a set of simple questions related to urinary incontinence symptoms, which the individual answers. The questions address the type and frequency of incontinence episodes, as well as their impact on daily life. The higher the score, the more severe the condition.
1 secondary outcome
Pad-counting Score
Time frame: T0 (baseline); T1 (day after 24th treatment); T2 (day after 36th treatment); T3 (day after 48th treatment); T4 (day after 60th treatment); T5 (day after 72nd treatment).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Derived from this study: PubMed 41286037Li T, Wang S, Chen Q, Lv T, Huang Z. Electrical pudendal nerve stimulation versus pelvic floor muscle training with transrectal electrical stimulation for post-radical prostatectomy incontinence: a cohort study. Sci Rep. 2025 Nov 24;15(1):41603. doi: 10.1038/s41598-025-25567-3.
- Individual participant dataSharing planned: Undecided. If necessary, contact Dr. Siyou Wang to provide the original data.
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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.
Siyou Wang principal investigator
Shanghai research institute of acupuncture and meridian
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Incontinence Following Surgical Procedure, run by Shanghai Institute of Acupuncture, Moxibustion and Meridian 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 3 inclusion and 7 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: finished, as of the sponsor's last update on 13 Jun 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Consultation on Incontinence Questionnaire-short form score (ICIQ-SF) (time frame: T0 (baseline); T1 (day after 24th treatment); T2 (day after 36th treatment); T3 (day after 48th treatment); T4 (day after 60th treatment); T5 (day after 72nd treatment).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06130306, which also lists 1 linked publication.
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 13 Jun 2025.