Hybrid Fractional Laser Treatment for Symptoms of Urinary Incontinence
Urinary IncontinenceStress Urinary Incontinence1 moreThis multi-center clinical trial will evaluate the safety and long-term efficacy of hybrid fractional 2940 nm and 1470 lasers for improvement of symptoms of urinary incontinence.
Transcutaneous Electric Nerve Stimulation (TENS) for the Treatment of Nocturnal Enuresis in Children...
Nocturnal EnuresisBedwettingChildren referred to the pediatric urology clinic for primary nocturnal enuresis will be screened for enrollment. Patients who fail behavioral therapy and who meet inclusion criteria will be offered therapy with a TENS unit. Patients will be randomized into four groups. Group 1 will be the direct bladder stimulation arm with electrodes placed onto the abdomen in the suprapubic region directly over the bladder. Group 2 will be the distal neural loop arm with electrodes placed over the posterior tibial nerve. Group 3 will be the proximal neural loop arm with electrodes placed about 2-3 cm lateral to the midline in the sacral region at the level of S3. Group 4 will be the control arm with electrodes placed on the scapula. We will aim to recruit 32 patients per group for a total of 128 patients. The patients will be provided with a TENS unit (TENS 3000 Analog) and electrode pads and caretakers instructed on how to use the apparatus. The TENS sessions will be performed nightly before bed for 15 minutes. TENS units will be set at a frequency of 10 Hz, and intensity determined by the sensitivity threshold of the patient. Diaries including nighttime incontinence episodes and a "wet sheet" scale (dry, damp, wet, soaked) will be recorded, along with any adverse reactions to the TENS unit. Patients will be followed up after one month of TENS with evaluation including the Pediatric Urinary Incontinence Questionnaire, a validated tool for measuring quality of life in children with bladder dysfunction; this questionnaire will be filled out prior to starting TENS treatment in order to compare the effect of treatment on QOL. . They will then follow up on these parameters again after another month (one month off of TENS therapy) to assess the durability of treatment effect. The data will be collected at different time points (baseline, 1 month, 2 months) for each group by itself and the groups compared against each other using statistical analysis.
A Phase 2 Study of TAS-303 in Female Patients With Stress Urinary Incontinence
Stress Urinary IncontinenceThe purpose of this study is to evaluate the efficacy and safety of TAS-303 in female patients with stress urinary incontinence.
Treatment of Stress Urinary Incontinence in Women With Autologous Adipose-derived Mesenchymal Stem...
Stress Urinary IncontinenceTreatment of women with stress urinary incontinence using injection of autologous adipose-derived mesenchymal stem cells mixed with collagen gel
Pelvic Floor Muscle Training With a Digital Therapeutic Device to Standard Exercises for Stress...
Stress Urinary IncontinenceA virtual prospective randomized controlled study to evaluate the efficacy of using the leva® Pelvic Digital Health System (PDHS) to perform PFMT compared to a standard home exercise home program for the treatment of SUI/SMUI. The treatment part of the study lasts eight weeks and has two arms. One group will receive routine care consisting of at-home Kegel exercises, and the other will be provided with a leva® device and instructions for use. Subjects in both groups will be assessed at baseline, then at 4 and 8 weeks for change and improvement of their symptoms. They will also be assessed at 6 and12 months after study completion.
Effect of External Electrical Stimulation and Pelvic Floor Muscle Training
Urinary IncontinenceStress3 moreIn this study, the effects of the external electrical stimulation (EES) added to pelvic floor muscle training (PFMT) on stress urinary incontinence (SUI) were investigated.
Ancillary Study of the Lessening Incontinence With Low-impact Activity Study
Urinary IncontinenceThe parent trial that supports this ancillary research is a randomized controlled trial to evaluate the efficacy of a group-based yoga intervention to decrease the frequency and impact of urinary incontinence in ambulatory middle-aged and older women. Women aged 45 years and older who report daily or more frequent stress-, urgency-, or mixed-type incontinence, are not already engaged in formal yoga or muscle stretching/strengthening programs, are willing to temporarily forgo other clinical treatments for incontinence, are able to walk to and use the bathroom without assistance, and meet other eligibility criteria are being recruited from multiple locations surrounding the San Francisco Bay area. Following a series of telephone- and then clinic-based screening assessments, including a voiding diary to confirm the frequency and clinical type of incontinence, eligible women are randomized in a 1:1 ratio to participate in either a 3-month yoga program (N~120) or a time-equivalent, non-specific muscle stretching and strengthening control program (N~120). During the 3-month intervention period, participants participate in structured intervention programs (either yoga-specific or muscle stretching-strengthening) consisting of twice weekly, 90-minute group classes led by trained instructors). They are also be instructed to practice their assigned intervention for at least an additional hour per week, with the assistance of participant manuals created by the study team and a set of home yoga or stretching/strengthening exercise props. For this ancillary trial research, the investigators are examining ancillary measures of a) physical performance status, b)perceived stress, depression, and anxiety symptoms, and c) sleep quality, duration, and continuity, already incorporated by the principal investigator into the parent trial. The investigators will examine prospective relationships between these ancillary measures and participant-reported urinary incontinence frequency/severity/impact, examine intervention effects on these ancillary outcomes, and assess the extent to which these ancillary outcomes mediate intervention effects on incontinence frequency/severity/impact.
Improving Female Sexual Wellness
SexualitySexual Dysfunction8 moreThe purpose of this study is to assess the effect of commercially available genital vibrator use on sexual health, female pelvic floor disorders, and overall quality of life among a diverse population of women.
Effects of Osteopathic Manipulations and Muscle Training on the Myoelectric Activity of the Pelvic...
Urinary IncontinenceThe objective of this study was to compare the effects of four different interventions on pelvic floor muscle electromyographic activity in women with stress urinary incontinece: i) a global osteopathic protocol (myofascial, visceral, and articular techniques), ii) one manipulation technique (high velocity, low amplitude (HVLA)/thrust) of the sacroiliac joint and T10-L2, iii) Pelvic Floor Muscle training, and iv) a control group with no intervention. The hypothesis is that the global osteopathic protocol and HVLA technique can increase pelvic floor muscle electromyographic activity to a level greater than or equal to the standard care established in the literature (pelvic floor muscle training).
URO-902 in Female Subjects With Overactive Bladder and Urge Urinary Incontinence
Overactive Bladder With Urge Urinary IncontinenceThis study will evaluate the efficacy, safety, and tolerability of a single dose of URO-902 24 milligrams (mg) and 48 mg (administered via intradetrusor injection), compared with placebo, in participants with overactive bladder (OAB) and urge urinary incontinence (UUI) up to 48 weeks post-dose.