Pelvic Floor Disorders

19

Review clinical trials related to Pelvic Floor Disorders. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

Botox for Chronic Pelvic Pain

The purpose of this research study is to find out if precise, targeted injection of botulinum neurotoxin (commonly known as Botox) provides better relief of pelvic floor hypertonicity and pain than the standard method being used. The researchers want to better understand the effects (good and bad) of targeted botulinum neurotoxin injections in women with pelvic floor disorders.

Participants needed: 30
Trial details
Phase: Phase 1Age: 18-75Biological sex: FemaleType: InterventionalSponsor: University of MiamiUpdated: Jun 17, 2026Locations: 1
Eligibility criteria

Females between 18 and 75 years of age [+6]

Males [+7]

Status: Not yet recruiting

Therapeutic Exercise for Postpartum Recovery

Pelvic floor dysfunctions (PFDs) are common conditions that affect women, especially after vaginal childbirth. These disorders can cause urinary or fecal incontinence, pain during sexual activity, and prolapse of pelvic organs, leading to a significant decrease in quality of life. Current scientific evidence shows that early and specific physiotherapy-based interventions after childbirth may help reduce the risk of developing long-term PFDs. Pelvic floor muscle training (PFMT) is currently the first-line conservative treatment for women with PFD, but in recent years other exercise methods, such as hypopressive exercises, have become increasingly popular, despite limited supporting evidence. At the same time, some women need to return early to physically demanding jobs or impact sports, but there are no clear guidelines on how to safely prepare the abdominopelvic region for progressive exposure to increased intra-abdominal pressure. This study aims to compare two postpartum recovery exercise programs: A program based on lumbopelvic stabilization exercises that progressively expose women to increases in intra-abdominal pressure and impact activities. A program based on hypopressive exercises, which focus on avoiding intra-abdominal pressure. The goal is to determine which approach is safer and more effective in improving pelvic floor recovery after childbirth and in supporting women in their gradual return to daily, work, and sports activities.

Participants needed: 84
Trial details
Age: 18+Biological sex: FemaleType: InterventionalSponsor: University of AlcalaUpdated: May 4, 2026Locations: 1
Eligibility criteria

Primiparous or multiparous women with an uncomplicated vaginal delivery. [+2]

Cesarean delivery. [+11]

Status: Recruiting

Early Pelvic Floor Physical Therapy for Women Undergoing Pelvic Radiation for Gynecologic Malignancies

This is a single arm phase II study in which 28 patients who will be undergoing definitive pelvic external beam radiation therapy for cervical cancer will receive pelvic floor physical therapy 4 weeks after completing radiation therapy.

Participants needed: 28
Trial details
Age: 18+Biological sex: FemaleType: InterventionalSponsor: University of CincinnatiUpdated: Apr 23, 2026Locations: 1
Eligibility criteria

Participants must be female. [+4]

Any previous therapeutic pelvic radiation. [+1]

Status: Not yet recruiting

Maternal Musculoskeletal Factors of the Hip, Lumbopelvic, Abdominal and Pelvic Floor Regions and Their Association With Mode of Delivery and Postpartum Pelvic Floor Dysfunction

This prospective observational cohort study aims to investigate the association between maternal musculoskeletal factors of the hip, lumbopelvic, abdominal, and pelvic floor regions and childbirth outcomes, as well as their consequences on pelvic floor function during the postpartum period. A total of 376 pregnant women will be recruited at 36 weeks of gestation and followed until 12 weeks postpartum. Musculoskeletal assessments will include hip range of motion, lumbopelvic mobility, abdominal muscle function, and pelvic floor strength and morphology. Obstetric outcomes such as mode of delivery and perineal trauma will be recorded after childbirth. The study will analyze whether maternal musculoskeletal function during late pregnancy is associated with delivery mode and pelvic floor dysfunction in the postpartum period.

Participants needed: 376
Trial details
Age: 18-45Biological sex: FemaleType: ObservationalSponsor: Universitat Internacional de CatalunyaUpdated: Mar 17, 2026
Eligibility criteria

Pregnant women aged 18 years or older [+4]

Multiple pregnancy [+4]

Status: Recruiting

Perineal Massage Using A Pelvic Wand During Pregnancy

There is limited research on the optimal strategy to reduce obstetric laceration, postpartum urinary retention, and postpartum pelvic pain. In systematic reviews, clinician-directed massage of the perineal muscles at the time of birth and patient directed massage of the perineal muscles in the third trimester to inconsistently reduce the incidence of severe obstetric laceration.1,2 However, there is significant heterogeneity of these studies is due in large part to the lack of a standardized protocols and unpredictability of clinician availability to perform perineal massage around the time of birth. The purpose of this study is to understand how perineal massage with a pelvic wand in late pregnancy and during labor influences one's sense of self-control over the labor process and birth experience.

Participants needed: 140
Trial details
Phase: Phase 4Age: 18+Biological sex: FemaleType: InterventionalSponsor: Beth Israel Deaconess Medical CenterUpdated: Mar 9, 2026Locations: 1
Eligibility criteria

Pregnant [+4]

Contraindication to vaginal birth, active genital herpes infection, fetal anomal...

Status: Not yet recruiting

A Randomized, Placebo-controlled Trial of Nitrous Oxide During In-office Bladder Botox Injections

The goal of this clinical trial is to assess if a mix of nitrous oxide and oxygen can improve pain control during bladder Botox injections. The primary question it aims to answer is: Does using nitrous oxide lower the overall level of pain during the procedure? Researchers will compare a 50:50 nitrous oxide/oxygen mixture (administered with the Pro-Nox system) plus standard care (with lidocaine in the bladder) to sham mask plus standard care to see if nitrous oxide works better for lowering pain. Participants will: * Receive their bladder Botox injection in the office setting * Either use nitrous oxide/oxygen plus standard care during the procedure, or sham mask plus standard care * Answer brief questions about pain, anxiety, satisfaction, and willingness to repeat the procedure

Participants needed: 96
Trial details
Phase: Phase 4Age: 18+Biological sex: FemaleType: InterventionalSponsor: TriHealth Inc.Updated: Feb 4, 2026Locations: 2
Eligibility criteria

Adult women ≥18 years old scheduled for in-office intradetrusor botulinum toxin...

Known/suspected vitamin B12 or folate deficiency or high-risk state (e.g., perni... [+7]

Status: Recruiting

Evaluation of the Subjectively Perceived Pelvic Floor Function in Patients With Gynecological Tumors and Breast Cancer Under Systemic Tumor Therapy Using a Validated Questionnaire

The multimodal therapy of gynecological malignancies and breast cancer often leads to an impairment of the pelvic floor function. This has a major impact on the quality of life of cancer patients. The aim of the study is to record and analyze the potential subjective impairment of the bladder, bowel and sexual function under systemic tumor therapy as well as possible influencing factors by means of validated disease-specific questionnaires. to find possible starting points for the prevention and treatment of the symptoms.

Participants needed: 200
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: St. Josefs-Hospital Wiesbaden GmbHUpdated: Sep 23, 2025Locations: 1Duration: 3 Years
Eligibility criteria

Breastcancer under tumor therapy [+1]

none

Status: Not yet recruiting

A Novel Medical System for Quantitative Diagnosis and Personalized Precision Botulinum Neurotoxin Injection in Chronic Pelvic Pain Management

The purpose of this study is to evaluate if it is possible to use intravaginal high-density surface electromyography to guide Botulinum neurotoxin (BoNT) injection to treat pelvic floor muscle overactivity that complicates Chronic Pelvic Pain (CPP).

Participants needed: 46
Trial details
Phase: Early Phase 1Age: 18-60Biological sex: FemaleType: InterventionalSponsor: HillMed Inc.Updated: Aug 19, 2025Locations: 1
Eligibility criteria

Woman aged 18 to 60. [+6]

History of pelvic malignancy and sexually transmitted diseases. [+13]

Status: Recruiting

Pelvic Floor Rehabilitation of Female Pelvic Floor Dysfunction

The goal of this observational study is to learn about the therapeutic effects of different pelvic floor rehabilitation treatments, including pelvic floor muscle training , pelvic floor biofeedback electrical stimulation, and magnetic stimulation, in a population of Chinese patients with female pelvic floor dysfunction disorders. The study aims to find out the individualised pelvic floor rehabilitation treatment plan suitable for the Chinese population. The main question it aims to answer is: 1. Do patients with reduced pelvic floor muscle strength after childbirth, or patients with mild to moderate pelvic organ prolapse and symptomatic pelvic organ prolapse benefit from pelvic floor rehabilitation? 2. Is the combination of biofeedback electrical stimulation plus pelvic floor magnetic stimulation superior to single electrical stimulation, magnetic stimulation or pelvic floor muscle training? 3. Which pelvic floor rehabilitation therapy is most suitable for Chinese patients with female pelvic floor dysfunction? 4. What factors are early predictors of developing female pelvic floor dysfunction? And what factors can predict the prognostic status of patients treated with pelvic floor rehabilitation? Participants in the multicenter will be treated with different rehabilitation therapies, during which the researchers will collect clinical symptoms using the PFDI20 questionnaire, and POP-Q scores, pelvic floor muscle strength, and electromyography results from participants before, at the end of, and 3 months and 1 year after the end of treatment.

Participants needed: 1,360
Trial details
Age: 18+Biological sex: FemaleType: ObservationalSponsor: Mingfu WuUpdated: Aug 1, 2025Locations: 1
Eligibility criteria

knowledge of the study, voluntary enrolment in the study, and signing of informe... [+1]

history of comorbid serious medical or surgical illness; [+3]

Status: Recruiting

Monocentric Prospectiv Observational Clinical Trial of Pelvic Floor Biometry During Pregnancy and Puerperium

Pregnancy, childbirth and the puerperium determine significant changes in the muscular, fascial and support structures of the pelvic floor. These changes, both physiological (i.e. dictated by the adaptations that pregnancy determines at the level of the connective tissue, collagen and pelvic-perineal muscular structures) and the changes induced by the passage of the fetus through the birth canal (obstetric lacerations, episiotomy and muscle avulsions) cause a weakening of the pelvic support structures with the possible onset of dysfunctional symptoms, which are not only common in old age, but become evident already in childbearing age. Previous studies on the composition of connective tissue show significant changes in the collagen component both in continent women and in those who experience stress urinary incontinence. These changes are revealed in approximately 24% of the population that suffers from urinary incontinence. Collagen is the main component of the endopelvic fascia. During pregnancy, the hormonal influence typical of this phase determines significant changes in the mechanical properties of the connective tissue and muscle fibers of the levator ani, which tend to hypertrophy and lengthen. This may also explain why cesarean delivery, elective or after the onset of labor, is not fully protective against the development of pelvic floor dysfunction. However, pelvic floor changes may have occurred before delivery and may not necessarily be related to labor and delivery itself. Incontinence, mostly temporary in pregnancy, must be interpreted as the result of these factors in addition to the increased pressure on the urethrovesical junction caused by the gravid uterus. Stretching of connective tissues beyond their physiological limits during labor, resulting in levator ani injury and/or possible neurogenic stretch damage, occurs in the majority of women who give birth vaginally, but in most women, muscle hypertrophy and nerve fiber adaptation compensate for this pathological pattern. In a minority (5-20%) of women, major levator ani defects and neurogenic lesion may lead to irreversible changes in pelvic floor function. Pelvic floor imaging after pregnancy has improved the understanding of the etiology of pelvic floor disorders in animal models. Patients who already present with pelvic static dysfunction and urinary incontinence during pregnancy tend to develop the same problems in the puerperium. However, to date it is not known what moment in pregnancy these changes in the pelvic tissue begin and that cause the progressive change in the myo-connective components of pregnancy. The lack of prospective cohort studies of pregnant and postpartum subjects does not allow a conclusive opinion on this topic. Pelvic floor ultrasound performed transpeineally, useful for evaluating pelvic biometry, is a non-invasive method and well tolerated by the patient, not only in postpartum but also during pregnancy. A previous study examined pelvic floor changes during pregnancy, reporting how the progression of pregnancy determines changes in the anatomical components of the pelvic floor, without however correlating the data with the puerperium and the longer-term outcomes of these changes. We did not identify any previously published studies that attempted to comprehensively assess biometric changes of the pelvic floor during pregnancy and postpartum using not only ultrasound imaging, but also clinical assessment and validated urinary symptom questionnaires.

Participants needed: 350
Trial details
Age: 18+Biological sex: FemaleType: ObservationalSponsor: Fondazione IRCCS Policlinico San Matteo di PaviaUpdated: Mar 10, 2025Locations: 1
Eligibility criteria

single pregnancy confirmed by ultrasound in the first trimester (within 10 weeks... [+4]

previous pregnancy ended with spontaneous vaginal delivery or cesarean section [+6]

Status: Recruiting

Pelvic Floor Dysfunction Among Female Physiotherapy Students: A Cross-Sectional Study

This study aims to: 1. estimate the prevalence of pelvic floor dysfunction among female physiotherapy students at Cairo University. 2. identify potential risk factors that may be associated with pelvic floor dysfunction in this student population. 3. assess the level of awareness regarding pelvic floor health among female physiotherapy students at Cairo University. 4. explore how female physiotherapy students at Cairo University utilize available healthcare resources for managing pelvic floor-related concerns.

Participants needed: 180
Trial details
Age: 18-25Biological sex: FemaleType: ObservationalSponsor: Cairo UniversityUpdated: Feb 25, 2025Locations: 1
Eligibility criteria

Virgin undergraduate physiotherapy students. [+1]

Neurological disorders or injuries that may affect pelvic floor function (e.g.,... [+3]

Status: Recruiting

Multicenter Study on the Correction of Prolapse Via Laparoscopy

In the laparoscopic lateral suspension (LLS) technique, the fixation of the mesh as a prosthetic element for correcting anterior apical vaginal prolapse at the level of the dome or uterus can offer anatomical and functional results that are not inferior to those of the conventional surgical technique, minimize possible intraoperative complications and facilitate the specific learning curve of sacropexy.

Participants needed: 181
Trial details
Age: 18+Biological sex: FemaleType: InterventionalSponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de MurciaUpdated: Feb 7, 2025Locations: 1
Eligibility criteria

Patients with Stage II- IV primary or recurrent prolapse affecting the anterior...

History of abdominal prolapse reconstructive surgery. [+5]

Status: Recruiting

Effects of Reformer Pilates in Pregnant Women

Pregnancy is known as a period associated with important physiological and psychological changes in women's lives. There is moderately sufficient evidence in the literature to recommend supplementing prenatal physical activity for maternal health benefits. It has been reported that physical exercise by pregnant women in the absence of obstetric contraindications will not pose a risk to the health of the mother and fetus. In the literature, there are no studies examining the effects of reformer pilates on pain, functional capacity, lumbopelvic stabilization, diastasis recti abdominis, abdominal muscle thickness, respiratory functions, pelvic floor dysfunction, urinary incontinence, sexual function, and venous insufficiency in pregnant women. Therefore, this study aimed to investigate the effects of reformer pilates on pain, functional capacity, lumbopelvic stabilization, diastasis recti abdominis, abdominal muscle thickness, respiratory functions, pelvic floor dysfunction, urinary incontinence, sexual function, and venous insufficiency in pregnant women.

Participants needed: 30
Trial details
Age: 18-35Biological sex: FemaleType: InterventionalSponsor: Izmir Democracy UniversityUpdated: Jan 16, 2025Locations: 1
Eligibility criteria

Single pregnancy [+5]

Multiple pregnancies [+4]

Status: Recruiting

Perineal Massage in Pregnancy to Reduce the Levator Ani Coactivation

The goal of this clinical trial is to test the efficacy of the perineal massage in reducing the levator ani muscle (LAM) co-activation. This phenomenon is characterized by the LAM contraction rather than its relaxation during the Valsalva maneuver and it is associated with adverse obstetric outcome. Participants who co-activate will be enrolled and randomized in 2 groups: group A, where women themselves perform the perineal massage during the third trimester of pregnancy and group B, where women undergo the standard care. Researchers will compare these groups to see if the perineal massage is able to reduce LAM co-activation.

Participants needed: 58
Trial details
Age: 18-40Biological sex: FemaleType: InterventionalSponsor: Azienda Sanitaria Universitaria Friuli CentraleUpdated: Aug 2, 2024Locations: 1
Eligibility criteria

nulliparous [+3]

multiparous [+6]

Status: Recruiting

Effectiveness of Pelvic Floor Exercise to Prevent LARS (Low Anterior Resection Syndrome)

The main aim of this randomized study will be to determine the effectiveness of pelvic floor exercises on the incidence or severity of LAR syndrome in patients after mini-invasive rectal resection. The main questions it aims to answer are: * Does pelvic floor exercise after low anterior resection prevent LARS (low anterior resection syndrome)? * What is the adherence of patients to prescribed home exercise after surgery? * Quality of life after LAR Researchers will compare the group of patients with pelvic floor exercises to those without and determine the occurrence and severity of LARS. Participants will: * under the professional guidance of a physiotherapist, the day before surgery and in the first 4 postoperative days be educated to exercise the pelvic floor * continue exercise at home for a month (according to the instructions together with the infographic)

Participants needed: 50
Trial details
Age: 19+Biological sex: AllType: InterventionalSponsor: F. D. Roosevelt University HospitalUpdated: Jul 25, 2024Locations: 1
Eligibility criteria

Cognitive functions make it possible to understand and sign the patient's in... [+1]

not agreeing to participate in the study [+3]

Status: Recruiting

Correlation Pelvic Floor Function and Ultrasound Findings One Year After Childbirth

This is a single-center prospective cohort study sponsored by the University Hospitals Leuven (UZ). Women will undergo a pelvic floor ultrasound and will be asked to fill out a questionnaire at the time of their admission into the labour suite, at the postpartum check-up and 12 months postpartum. The primary objective is to correlate self-reported symptoms of Pelvic Floor Dysfunction (PFD) (binary outcome) at one year after delivery with structural changes to the Pelvic Floor Muscles (PFM) and postpartum evidence of levator avulsion (binary indicator) as measured by TransPerineal UltraSound (TPUS). Secondary objectives are to compare demographical and obstetrical variables between patients suffering from PFD symptoms or pelvic floor injury (documented one year after delivery) and those who do not; to record how patients manage and cope with PFD including recovery and compliance with Pelvic Floor Muscle Training (PFMT) as prescribed in the standard pathway of peripartum care; and to use of TPUS images for the development of artificial intelligence tools for automated image analysis. Primary outcomes are PFD symptoms one year after delivery and injury to the PFM evidenced by POP-Q and TPUS. The demographic variables and information about the pregnancy and the delivery will be obtained from the medical records. The presence and severity of PFD will be measured using standardized self-reporting tools: Pelvic Organ Prolapse Distress Index (POP-DI), Patient Assessment Constipation-SYMptoms (PAC-SYM), International Consultation on Incontinence Questionnaire - Urinary Incontinence - Short Form (ICIQ-SF), St. Mark's Incontinence Score (SMIS), Female Sexual Function Index (FSFI), Female Sexual Distress Scale - Revised (FSDS-R). FSFI is a widely used generic tool with sufficient granularity and validated in a large number of languages. FSDS-R assesses the construct "personal distress", which has been considered as an additional important aspect contributing to sexual dysfunction of women. PFD, as a clustered outcome, being the presence of any kind of pelvic floor dysfunction symptoms, will be defined as POP-DI score of ≥11 OR ICIQ-SF score of ≥1 OR SMIS score of ≥1 OR FSFI score ≤ 26.55 OR FSDS-R score ≥11.

Participants needed: 320
Trial details
Age: 18-45Biological sex: FemaleType: InterventionalSponsor: Universitaire Ziekenhuizen KU LeuvenUpdated: Jul 1, 2024Locations: 1
Eligibility criteria

age = or > 18 years [+4]

age < 18 years [+8]

Status: Not yet recruiting

Prevalence of Pelvic Floor Dysfunctions in Female Badminton Athletes and Sedentary

The objective of the study is to know the prevalence of pelvic floor dysfunctions in female badminton athletes compared to sedentary women, and the hypothesis is that the prevalence of pelvic floor dysfunctions is going to be higher in female badminton athletes.

Participants needed: 100
Trial details
Age: 20+Biological sex: FemaleType: ObservationalSponsor: University of AlcalaUpdated: Jun 12, 2024Locations: 1
Eligibility criteria

Cases: women who practice recreational badminton and/or are federated and compet... [+1]

Connective tissue diseases (Ehlers-Danlos syndrome, Marfan syndrome or hypermobi... [+3]

Status: Recruiting

The Intermediate and Long-term Follow up of Home Based Pelvic Muscle Training

When participants present with symptoms of pelvic organ prolapse (POP) and stress urinary incontinence (SUI), the investigators will perform a comprehensive evaluation and initially provide conservative treatment. If conservative treatment fails, invasive treatment will be considered. The investigators will arrange a pelvic muscle training course two to three times a week for a duration of 1.5 months per course. However, participants may complain about the inconvenience of traffic, which may lead to discontinuation of the pelvic training course. Therefore, the investigators propose the development of a home-based pelvic muscle training device and will collaborate with information engineering specialists at Tamkang University to invent the device for home-based pelvic muscle training.

Participants needed: 200
Trial details
Age: 18+Biological sex: FemaleType: ObservationalSponsor: Taipei Veterans General Hospital, TaiwanUpdated: Mar 21, 2023Locations: 1
Eligibility criteria

Age > 18-year-old, non-pregnancy, SUI, bladder capacity > 300ml, RU<150ml, pelvi...

recurrent UTI, cancer patients, chronic pelvic pain, psychologic problems

Status: Recruiting

HIIT vs MICT During Pregnancy and Health and Birth Outcomes in Mothers and Children

Regular exercise during pregnancy and postpartum leads to health benefits for mother and child. Inactivity during pregnancy and after delivery is now treated as risky behavior. Physically active pregnant women significantly less often suffer from, among others, gestational diabetes, excessive weight gain, lipids disorders, hypertension, preeclampsia, depressive symptoms, functional and structural disorders, including stress urinary incontinence, back pain or diastasis recti abdominis (DRA). Prenatal physical activity reduces the risk of premature delivery and miscarriage, fetal macrosomia, complications in labor or the risk of metabolic disorders in children. High-intensity interval training (HIIT) has become one of the most popular trends in the fitness sector. The effectiveness of HIIT on a number of health indicators has been proven in various populations but limited data are available on HIIT during pregnancy. The first hypothesis is that the HIIT, implemented during pregnancy and after childbirth, as a stronger exercise stimulus, will have a better impact on selected biological and psychological parameters of mothers, as well as on selected health parameters of their children, compared to the MICT (moderate intensity continuous training). Therefore, it promises better preventive effects on pregnancy complications and ailments as well as non-communicable diseases occurring in these populations. In the second hypothesis, it was assumed that HIIT and MICT implemented during pregnancy and after childbirth, tailored to the specific needs of the perinatal period, will not differ in the effectiveness of maintaining normal functional parameters in women, including prevention of urinary incontinence, back pain, DRA, etc. Pregnant women who apply for the study will be divided into three groups: those attending the HIIT, MICT or educational programs. During the study, the participants will be under standard obstetric care. As comparative groups, non-pregnant women will be also recruited. The investigators will collect data on selected biological, functional and psychological parameters in the study women at each trimester of pregnancy, during the puerperium and one year after childbirth. The data from the medical documentation on the course of childbirth and the assessment of the new-born, as well as the results of preventive examinations in the study women's children aged one, two, four and six years will be also analyzed.

Participants needed: 600
Trial details
Age: 18-45Biological sex: FemaleType: InterventionalSponsor: Gdansk University of Physical Education and SportUpdated: Dec 2, 2022Locations: 1
Eligibility criteria

course of pregnancy allowing participation in physical activities adapted to pre... [+12]

contraindications to increased physical effort or to any of the diagnostic or co... [+2]