Clinical Research Directory

Single-incision Versus Retropubic Mid-Urethral Sling (Solyx) for SUI During Minimally Invasive Sacrocolpopexy

SASS (Single-incision Versus Retropubic Mid-Urethral Sling (Solyx) for SUI During Minimally Invasive Sacrocolpopexy) will be a multicenter, prospective, randomized, single-blind non-inferiority trial.

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.

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.

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.

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.

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

Effects of Pelvic Exercises on Birth and Incontinence

The Effect of Pelvic Floor Exercises During Pregnancy on Obstetric Outcomes and Urinary Incontinence: A Prospective Randomized Controlled Trial

Improving Women's Function After Pelvic Radiation

The purpose of the study is to develop and test an intervention combining physical therapy (PT) and coping skills training to improve women's sexual function after pelvic radiation.

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.

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).

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.

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.

Assessment of Rectus Abdominis Muscle Thickness and Residual Bladder Volume Before and After Pelvic Floor Exercises

The study will be conducted on 40 women between the ages of 20-40 who volunteer to participate in the study. All participants will be selected from individuals who have been diagnosed with pelvic floor dysfunction and have no history of pelvic surgery. Pelvic floor dysfunction will be diagnosed by an Obstetrics and Gynecology Specialist. Participants will be divided into two groups as the Pelvic floor exercise group and the control group.

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.

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.

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.

Effect of Local Estriol Treatment Before Vaginal Repair Surgery

The aim of the study is to evaluate the effects of local estriol treatment applied before vaginal repair surgery on steroid receptors, inflammatory cell response, vascular, connective and nervous tissues in the vagina, and its effects on early postoperative period pelvic floor functions, satisfaction with the surgery and vaginal health.

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.

Factors Influencing Hemodynamic Stability and Its Management in Patients Undergoing Pelvic Surgery Under Spinal and GA

Patients are at risk for hemodynamic instability both during and after surgery, as it is an independent predictor of long-term patient morbidity and length of hospital stay. The development of hemodynamic instability is caused by a number of factors. When these risk factors are prevented or treated, patients may experience less hemodynamic instability during pelvic surgery, as well as the morbidity and mortality that come with it in both spinal and general anesthesia.

Digital Care Programs for Female Pelvic Health

The purpose of this study is to create a research repository, composed of data collected in the course of digital care programs for pelvic health conditions by SWORD Health/Bloom to individuals undergoing those programs. This will allow the investigators to observe the acceptance, engagement and outcomes of programs using this approach in the treatment of multiple pelvic health disorders.

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.

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)

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.

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.