Clinical Research Directory

Effects of Kegel Ball and Pelvic Floor Exercises on Sexual Function, Unrınary Incontinence and Quality of Life in Women

Urinary incontinence and sexual dysfunction are common conditions that can significantly impact quality of life. Although surgical and medical treatments are available, many individuals seek non-invasive alternatives. Pelvic floor muscle training, also known as Kegel exercises, aims to strengthen the pelvic muscles that support the bladder and other pelvic organs. The use of vaginal Kegel balls may enhance the effects of these exercises by promoting increased muscle activation and pelvic awareness. Preliminary findings suggest that regular pelvic floor muscle training may improve urinary control and enhance sexual function through improved muscle strength and proprioception. This study aims to investigate the effectiveness of pelvic floor muscle exercises and Kegel ball utilization as non-invasive options for improving pelvic health, urinary continence, and sexual well-being. A total of 40 female participants with pelvic floor muscle weakness, urinary incontinence, and sexual dysfunction will be enrolled. All participants will undergo a physical examination. Muscle strength will be assessed using the Modified Oxford Scale, and prolapse levels, if present, will be determined using the Simplified POP-Q classification. Sociodemographic data will be collected, and participants will complete three face-to-face questionnaires. The Sandvick Severity Index (SSI) will be used to assess the severity of urinary incontinence. The International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), a validated questionnaire, will assess incontinence-related quality of life. The Female Sexual Function Index (FSFI), another validated instrument, will be used to assess sexual dysfunction. Participants will be randomized by drawing from closed envelopes containing 20 cards labeled "0" and 20 labeled "1." Those who draw a "0" will be assigned to the control group and will perform pelvic floor Kegel exercises. Those who draw a "1" will be assigned to the study group, which will perform the same exercises as the control group, along with the use of a vaginal Kegel exercise ball. All participants will receive a 6-week home-based exercise program targeting both fast-twitch (Type II) and slow-twitch (Type I) pelvic muscle fibers. The program will include fast and slow contractions, with imagery and analogies to improve comprehension. For fast contractions, the "open-close the tap" analogy will be used. For slow contractions, participants will be instructed to "squeeze while counting to five, hold for five, and relax for five," with the visualization of an elevator slowly ascending, stopping, and descending. Each exercise set will consist of ten rapid and ten slow contractions. Participants will be instructed to perform five sets per day during the first three weeks and increase to ten sets per day in the last three weeks. This equates to a total of 50 rapid and 50 slow contractions daily in the initial phase, increasing to 100 of each by the end of the intervention. Exercise tracking forms will be provided to allow participants to monitor compliance and document each completed session. Participants in the study group will be given a pelvic Kegel exercise ball to use. This device is 13.5 cm in total length, with a 3.5 cm ball width, weighs approximately 90 grams, and is made of medical-grade silicone. It contains two inner jiggle balls designed to generate passive vibrations against the vaginal wall during movement, potentially stimulating pelvic muscle activity. After receiving instruction on safe usage, participants in the study group will wear the Kegel ball for 30 minutes daily during the first three weeks, and for one hour daily during the final three weeks, while engaging in light daily activities such as walking or household movements. They will continue to perform the same exercises as the control group while integrating the device into their routine.

BELIEVE Trial: Bulking vErsus sLing for Treating Stress Urinary IncontinEnce at the Time of Vaginal prolapsE Repair (BELIEVE)

The goal of this clinical trial is to learn if retropubic midurethral sling (RP-MUS) or bulkamide injection (PAHG) at the time of pelvic organ prolapse repair is better from the patient's perspective. The main questions it aims to answer are: What is the average difference in the urogenital distress inventory (UDI) long form score 24 months after surgery for each procedure? Which procedure has the fewest complications and lowest short- and long-term morbidity profile? Participants will: Be blinded and randomized to one of two procedures for the duration of the study, 24 months. Complete 6 total visits for the clinical trial including validated questionnaires. Few participants will be selected to complete a qualitative interview at 3 timepoints over 24 month duration of the study.

Prospective Observational Prolapse Study

The rationale of the study is to investigate the results of a prolapse treatment in adult women with a vaginal prolapse. The investigators will investigate this by taking questionnaires in women undergoing a surgical prolapse repair and in women that are being treated by a vaginal pessary. The objective is to compare the results of the different methods with each other and to observe the evolution of the symptoms in patients undergoing surgery or pessary use. The investigators would also like to discover existing problems in pessary use and adverse effects.

Treatment of Vaginal Atrophy With Low Intensity Nanosecond Neodymium Laser

The aim of study is characteristic of changes in the vaginal wall after treatment of neodymium laser radiation with a wavelength of 1064 nm. To assess the condition of the vaginal walls before and after laser treatment, the following methods will be used: vaginal health index, perineometry, measurement of the vaginal wall thickness by ultrasound, Doppler sonography of the vaginal walls vessels, optical coherence tomography, biopsy, cytological and immunocytochemical methods. The King's Health Questionnaire will be used to collect feedback on changes in the participants life quality. Total up to 100 participants with and 20 participants without postmenopausal atrophy will be involved in the study. Participants will be divided into three groups: laser treatment (study group), topical hormones treatment (control group 1) and no treatment (control group 2) by 70, 30 and 20 participants in each group respectively. The time intervals between special tests and the tests themselves will be the same for all groups. Thus, a direct comparison between conventional treatment (topical hormones), laser treatment of the vaginal atrophy and normal condition without treatment will be made. The main hypothesis of the study is improvement in condition of the vaginal walls after laser treatment compared with the initial state of not less than thirty percent of participants, and improvement in condition on average compared with the control group.

The Impact of Long-term Pessary Use on Pelvic Organ Prolapse oìduring Covid-19 Pandemic in Patients Attending Surgery

Patients aged 45 to 80 years with a clinical diagnosis of stage III and IV genital prolapse involving the anterior and/or middle compartments and candidates for surgery will be considered. These will be evaluated to observe whether there is improvement in clinical prolapse with the use of the vaginal pessary during the waiting period for surgery