Stress Urinary Incontinence (SUI)NCT07081321
The Effect of Different Delivery Positions on Pelvic Floor Function.
A study testing Lithotomy position, Lateral Position and Upright Position in people with Stress Urinary Incontinence (SUI), run by Peking University People's Hospital at 1 site in China.
Trial summary
This study is a prospective, multicenter, randomized controlled trial. Baseline data will be collected from eligible subjects recruited during the third trimester of pregnancy. Participants will be randomized into three groups when cervical dilation reaches 2 cm based on delivery position: lithotomy position, upright… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress Urinary Incontinence (SUI)
- What is being tested?
- Lithotomy position, Lateral Position and Upright Position
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,992 participants
- Where
- 1 siteChina
- Study dates
- 20 Sep 2026to 31 Dec 2028
- Phase
- Interventional
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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 20 to 40 years.
- Singleton, cephalic presentation, full-term primipara.
- Absence of cephalopelvic disproportion.
- Estimated fetal weight (EFW) < 4000 g.
- Intended vaginal delivery and scheduled for postpartum follow-up at our hospital.
- Voluntary participation with provision of informed consent.
Who cannot join
- Moderate or severe stress urinary incontinence prior to pregnancy.
- Pelvic Organ Prolapse Quantification (POP-Q) stage ≥ III, or a history of treatment for pelvic floor dysfunction.
- Uncontrolled systemic medical diseases, or a history of asthma, allergic rhinitis, and constipation prior to pregnancy.
- Presence of contraindications to vaginal delivery.
- Presence of contraindications to the Valsalva maneuver (e.g., severe cardiopulmonary diseases, cervical incompetence, etc.).
- Withdrawal Criteria:
- The patient's clinical condition becomes unsuitable for continued study participation and follow-up.
- The subject requests to withdraw from the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking University People's Hospital
Beijing, Beijing Municipality, 100032
Lei Gao, MD, 17669675336, 1694833009@qq.com
About this study
Official title: Interventions for Geriatric Urinary Incontinence: The Effect of Intrapartum Interventions on Pelvic Floor Function
This study is a prospective, multicenter, randomized controlled trial. Baseline data will be collected from eligible subjects recruited during the third trimester of pregnancy. Participants will be randomized into three groups when cervical dilation reaches 2 cm based on delivery position: lithotomy position, upright position, and lateral position. During the second stage of labor, data regarding delivery positions, duration of each position, and other obstetric conditions will be recorded. Pelvic floor function assessments will be performed in the postpartum period to evaluate the outcomes.
- Conditions
- Stress Urinary Incontinence (SUI)
- Being tested
- Lithotomy position, Lateral Position, Upright Position
- Keywords
- Stress Urinary inconticence, Dlivery position, pevic floor muscle
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lithotomy positionBehavioural
Participants in the lithotomy decubitus position group were in the lithotomy position at the second stage of labor of delivery.
Lateral PositionBehavioural
Participants in the lateral position group were in the lateral position at the second stage of labor of delivery.
Upright PositionBehavioural
Participants in the upright position group were in the upright position at the second stage of labor of delivery.
| Study group | Role | What they receive |
|---|---|---|
| Lithotomy Position Group | Experimental | Participants in the lithotomy position group were in the lithotomy position at the second stage of labor of delivery Receives: Behavioral: Lithotomy position |
| Upright Position Group | Experimental | Participants in the upright position group were in the upright position at the second stage of labor of delivery. Receives: Behavioral: Upright Position |
| Lateral Position. | Experimental | Participants in the lateral position group were in the lateral position at the second stage of labor of delivery. Receives: Behavioral: Lateral Position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress urinary incontence (SUI) occurrence at 6 weeks postpartum
Measured: at 6 (±2) weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start20 Sep 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary Incontinence (SUI)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,992 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Luohe Central Hospital, The Third Xiangya Hospital of Central South University, Zhengzhou Central Hospital, Jincheng People's Hospital, Tongzhou Maternal and Child Healthcare Hospital of Beijing, Hangzhou maternity and child health care hospital
- Responsible party
- Principal investigator, Gao lei, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07081321
- Sponsor's protocol ID
- 2025PHB262-004
- Status last verified
- Sep 2026
- First submitted
- 26 Jun 2025
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Protection of research process and results • For unpublished research, data sharing may lead to the results being published first, damaging the academic rights and interests of the research team.