Biomechanical Integrity Score of the Female Pelvic Floor for Stress Urinary Incontinence.

INTRODUCTION AND HYPOTHESIS: This study is aimed at developing and validating a new integral parameter, the Biomechanical Integrity score (BI-score) of the female pelvic floor for stress urinary incontinence conditions. METHODS: A total of 130 subjects were included in the observational cohort study; 70 subjects had normal pelvic floor conditions, and 60 subjects had stress urinary incontinence (SUI). A Vaginal Tactile Imager (VTI) was used to acquire and automatically calculate 52 biomechanical parameters for eight VTI test procedures (probe insertion, elevation, rotation, Valsalva maneuver, voluntary muscle contractions in two planes, relaxation, and reflex contraction). Statistical methods were applied (t test, correlation) to identify the VTI parameters sensitive to the pelvic SUI conditions. RESULTS: Twenty-seven parameters were identified as statistically sensitive to SUI development. They were subdivided into five groups to characterize tissue elasticity (group 1), pelvic support (group 2), pelvic muscle contraction (group 3), involuntary muscle relaxation (group 4), and pelvic muscle mobility (group 5). Every parameter was transformed to its standard deviation units using the dataset for normal pelvic conditions, similar to the T-score for bone density. Linear combinations with specified weights led to the composition of five component parameters for groups 1-5 and to the BI-score in standard deviation units. The p value for the BI-score has p = 4.0 × 10-28 for SUI versus normal conditions. CONCLUSIONS: Quantitative transformations of the pelvic tissues, support structures, and functions under diseased conditions may be studied with the SUI BI-score in future research and clinical applications.

How I Do It: EnPlace sacrospinous ligament fixation.

Pelvic organ prolapse (POP) is a common condition that significantly impairs a woman's quality of life.  Currently a range of interventions from non-surgical to surgical options exist, all with their unique advantages and disadvantages.  Among these, the EnPlace system stands out as a truly minimally invasive transvaginal percutaneous device designed to repair apical POP by bilaterally anchoring sutures to the sacrospinous ligaments.  Readers will familiarize themselves with the EnPlace, relevant historical studies, and the technique for EnPlace transvaginal percutaneous sacrospinous ligament fixation for hysteropexy or colposuspension.

Single Incision Midurethral Sling Site of Care: Office-based Ambulatory Surgical Unit versus Hosptial-based Ambulatory Surgical Unit Setting.

STUDY OBJECTIVE: To compare the economic difference in terms of overall costs between two Ambulatory Surgical Unit (ASU) settings in which a midurethral single incision sling (MSIS) can be performed. DESIGN: A retrospective cohort study was carried out, examining the implanting of an MSIS performed at two different ASU settings by a single surgeon. Total cost was determined by assessing differences in charges and subsequent reimbursement associated with the procedure at each ASU setting. Time was measured using an EMR system for tracking both patient entry/exit from the facility as well as intraoperative time. Adverse events commonly associated with the procedure and patient-reported unanticipated adverse events were collected. A validated Surgical Satisfaction Questionnaire was administered postoperatively. SETTING: University Health Network Teaching Hospital. PATIENTS: A total of 125 women with stress urinary incontinence. INTERVENTION: MSIS. MEASUREMENT AND MAIN RESULTS: Between January 2016 until August 2020, 125 women underwent an MSIS procedure. The total office-based ASU (O-ASU) charges averaged $4564.00 (reimbursement of $2642.07). The total hospital-based ASU (H-ASU) charges averaged $40 136 (reimbursement of $9000), as well as an anesthesia average charge of $800 (reimbursement of $500). The average O-ASU total patient encounter time was 53.76 minutes versus 344.702 minutes for the H-ASU. There was no difference between commonly associated or unanticipated adverse events nor global patient satisfaction. CONCLUSIONS: Based on overall cost, total encounter time, and global patient satisfaction, a certified O-ASU is an optimal site of care for MSIS for surgical management of female stress urinary incontinence.

Biomechanical integrity score of the female pelvic floor.

INTRODUCTION AND HYPOTHESIS: The aim of this study is to develop and validate a new integral parameter, the Biomechanical Integrity score (BI-score), for the characterization of the female pelvic floor. METHODS: A total of 253 subjects with normal and pelvic organ prolapse (POP) conditions were included in the multi-site observational, case-control study; 125 subjects had normal pelvic floor conditions, and 128 subjects had POP stage II or higher. A Vaginal Tactile Imager (VTI) was used to acquire and automatically calculate 52 biomechanical parameters for eight VTI test procedures (probe insertion, elevation, rotation, Valsalva maneuver, voluntary muscle contractions in two planes, relaxation, and reflex contraction). Statistical methods were applied (t-test, correlation) to identify the VTI parameters sensitive to the pelvic conditions. RESULTS: Twenty-six parameters were identified as statistically sensitive to POP development. They were subdivided into five groups to characterize (1) tissue elasticity, (2) pelvic support, (3) pelvic muscle contraction, (4) involuntary muscle relaxation, and (5) pelvic muscle mobility. Every parameter was transformed to its standard deviation units against the patient age similar to T-score for bone density. Linear combinations with specified weights led to the composition of five component parameters for groups (1)-(5) and the BI-score in standard deviation units. The p-value for the BI-score has p = 4.3 × 10-31 for POP versus normal conditions. A reference BI-score curve against age for normal pelvic floor conditions was defined. CONCLUSIONS: Quantitative transformations of the pelvic tissues, support structures, and functions under diseased conditions may be studied with the BI-score in future research and practical applications.

Feasibility of a Fully Implanted, Nickel Sized and Shaped Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome with Urgency Urinary Incontinence.

PURPOSE: We performed a clinical feasibility trial to evaluate the safety and efficacy of a fully implanted, primary battery powered, nickel sized and shaped neuromodulation device called the eCoin® for tibial nerve stimulation to treat refractory urgency urinary incontinence. MATERIALS AND METHODS: This prospective, single arm, open label study included 46 participants with refractory urgency urinary incontinence. It was performed at multiple sites in the United States and New Zealand. The device was implanted in the lower leg over the tibial nerve and activated after 4 weeks. Bladder diary data and validated quality of life instruments were collected 3 and 6 months after activation and compared to baseline values. RESULTS: The mean ± SD age of participants was 63.4 ± 11.5 years and 45 (98%) were female. Episodes of urgency urinary incontinence were reduced a relative median of 71% after 3 months of treatment (4.2 vs 1.7 daily episodes at 3 months, p = 0.001). A 50% or greater decrease in reported episodes of urgency urinary incontinence was observed in 32 of 46 participants (69.6%) at 3 months with more than 20% dry at 3 and 6 months. I-QOL (Incontinence Quality of Life) scores improved an average of 25.9 points and 33 of 46 patients (72%) indicated improvement in symptoms. A single serious adverse event secondary to wound care resolved with intravenous antibiotics. CONCLUSIONS: The implantable neuromodulation device was a safe and effective treatment of urgency urinary incontinence associated with overactive bladder syndrome with a significant reduction or resolution of symptoms and no significant safety concerns.

A posterior anal sling for fecal incontinence: results of a 152-patient prospective multicenter study.

BACKGROUND: The transobturator posterior anal sling (TOPAS) system is a posterior anal sling that is a minimally invasive, self-fixating polypropylene mesh intended to treat fecal incontinence (FI) in women who have failed conservative therapy. OBJECTIVE: We are reporting 1-year outcome in a prospective, multicenter study under investigational device exemption, evaluating this new treatment modality. STUDY DESIGN: A total of 152 women were implanted with the TOPAS system at 14 centers in the United States. FI was assessed preoperatively and at the 12-month follow up with a 14-day bowel diary, Cleveland Clinic Incontinence Scores, and FI Quality of Life questionnaires. Treatment success was defined as reduction in number of FI episodes of ≥50% compared to baseline. Missing bowel diary data were considered treatment failures. The Wilcoxon signed rank test was used to compare changes observed at 12 months vs baseline. RESULTS: Mean age was 59.6 years old (SD 9.7). The mean duration of FI was 110 mo (range 8-712) months. Mean length of the implant procedure was 33.4 (SD 11.6) minutes. Mean EBL was 12.9 (SD 10.5) mL. Average follow-up was 24.9 months. At 12 months, 69.1% of patients met the criteria for treatment success, and 19% of subjects reported complete continence. FI episodes/wk decreased from a median of 9.0 (range 2-40) at baseline to 2.5 (range 0-40) (P < .001). FI days decreased from a median of 5.0 (range 1.5-7) at baseline to 2.0 (range 0-7) (P < .001) over a 7-day period. FI associated with urgency decreased from a median at baseline of 2.0 (range 0-26) to 0 (range 0-14.5) (P < .001). The mean Cleveland Clinic Incontinence Scores decreased from 13.9 at baseline to 9.6 at 12 months (P < .001). FI Quality of Life scores for all 4 domains improved significantly from baseline to 12 months (P < .001). A total of 66 subjects experienced 104 procedure- and/or device-related adverse events (AEs). Most AEs were short in duration and 97% were managed without therapy or with nonsurgical interventions. No treatment-related deaths, erosions, extrusions, or device revisions were reported. The most common AE categories were pelvic pain (n = 47) and infection (n = 26). Those subjects experiencing pelvic pain had a mean pain score (0-10 scale, 0 = no pain) during the 12-month follow-up of 1.2 (SD 2.4). CONCLUSION: The TOPAS system provides significant improvements in FI symptoms and quality of life with an acceptable AE profile and may therefore be a viable minimally invasive treatment option for FI in women.

Two-year Pivotal Study Analysis of the Safety and Efficacy of Implantable Tibial Nerve Stimulation With eCoin for Urgency Urinary Incontinence.

OBJECTIVE: To evaluate the continued effectiveness and safety of the eCoin Implantable Tibial Nerve Stimulator system (ITNS) for urgency urinary incontinence (UUI) in patients with overactive bladder (OAB). The 1-year pivotal study was extended through 2 years. The ITNS is a novel and recently FDA-approved therapy. METHODS: A prospective, multicenter, single-arm trial was conducted on 137 subjects with refractory UUI to evaluate eCoin ITNS therapy. A 3-day voiding diary was collected along with the OAB questionnaire, Patient Global Impression of Improvement, and a custom Likert scale on subject satisfaction. The primary efficacy measure was the proportion of subjects who achieved at least 50% reduction from baseline in number of UUI episodes. The primary safety measure was device-related adverse events (AEs). RESULTS: Seventy-two subjects completed the 96-week evaluation. Around 78% (95% CI: 67%-87%) experienced at least 50% reduction in UUI episodes; 48% (95% CI, 36%-60%) experienced at least 75% reduction, and 22% (95% CI, 13%-33%) were dry on a 3-day diary. Subjects reported a decrease from baseline in their UUI episodes/day of 2.61 (SD 2.97) and 2.97 (SD 2.64) at 48 weeks and 96 weeks, respectively. Around 91.3% did not require additional medications for OAB. No serious or unanticipated AEs were reported in this extension phase. CONCLUSION: The eCoin ITNS demonstrated consistent continuing effectiveness and safety in treating OAB patients with UUI. The findings support it as an excellent treatment option for refractory patients.

Laparoscopic sacrocolpopexy versus transvaginal mesh for recurrent pelvic organ prolapse.

Both expert surgeons agree with the following: (1) Surgical mesh, whether placed laparoscopically or transvaginally, is indicated for pelvic floor reconstruction in cases involving recurrent advanced pelvic organ prolapse. (2) Procedural expertise and experience gained from performing a high volume of cases is fundamentally necessary. Knowledge of outcomes and complications from an individual surgeon's audit of cases is also needed when discussing the risks and benefits of procedures and alternatives. Yet controversy still exists on how best to teach new surgical techniques and optimal ways to efficiently track outcomes, including subjective and objective cure of prolapse as well as perioperative complications. A mesh registry will be useful in providing data needed for surgeons. Cost factors are also a consideration since laparoscopic and especially robotic surgical mesh procedures are generally more costly than transvaginal mesh kits when operative time, extra instrumentation and length of stay are included. Long-term outcomes, particularly for transvaginal mesh procedures, are lacking. In conclusion, all surgery poses risks; however, patients should be made aware of the pros and cons of various routes of surgery as well as the potential risks and benefits of using mesh. Surgeons should provide patients with honest information about their own experience implanting mesh and also their experience dealing with mesh-related complications.

Efficacy and safety of oxybutynin chloride topical gel for women with overactive bladder syndrome.

OBJECTIVE: This subgroup analysis of a phase-3 study evaluated the efficacy and safety of oxybutynin chloride topical gel (OTG) in women with overactive bladder syndrome (OAB). STUDY DESIGN: Women (n = 704) with urgency-predominant urinary incontinence received OTG or placebo for 12 weeks. The primary endpoint was change from baseline to last observation in number of daily incontinence episodes. Treatments were compared with the use of analysis of covariance. RESULTS: OTG significantly reduced the number (mean ± standard deviation) of daily incontinence episodes (OTG, -3.0 ± 2.8 episodes; placebo, -2.5 ± 3.0 episodes; P < .0001), reduced urinary frequency (P = .0013), increased voided volume (P = .0006), and improved select health-related quality-of-life domains (P ≤ .0161) vs placebo. Dry mouth was the only drug-related adverse event significantly more common with OTG (7.4%) than with placebo (2.8%; P = .0062). CONCLUSION: OTG was well tolerated and provided significant improvement in urinary symptoms and health-related quality of life in women with OAB.

Quantifying vaginal tissue elasticity under normal and prolapse conditions by tactile imaging.

INTRODUCTION AND HYPOTHESIS: Vaginal tactile imaging (VTI) is based on principles similar to those of manual palpation. The objective of this study is to assess the clinical suitability of new approach for imaging and tissue elasticity quantification under normal and prolapse conditions. METHODS: The study subjects included 31 women with normal and prolapse conditions. The tissue elasticity (Young's modulus) was calculated from spatial gradients in the resulting 3-D tactile images. RESULTS: Average values for tissue elasticity for the anterior and posterior compartments for normal conditions were 7.4 ± 4.3 kPa and 6.2 ± 3.1 kPa respectively. For Stage III prolapse the average values for tissue elasticity for anterior and posterior compartments were 1.8 ± 0.7 kPa and 1.8 ± 0.5 kPa respectively. CONCLUSIONS: VTI may serve as a means for 3-D imaging of the vagina and a quantitative assessment of vaginal tissue elasticity, providing important information for furthering our understanding of pelvic organ prolapse and surgical treatment.

Time to rethink: an evidence-based response from pelvic surgeons to the FDA Safety Communication: "UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse".

In July of 2011 the U.S. Food and Drug Administration (FDA) released a safety communication entitled "UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse." The stated purpose of this communication is to inform health care providers and patients that serious complications with placement of this mesh are not rare and that it is not clear that these repairs are more effective than nonmesh repair. The comments regarding efficacy are based on a systematic review of the scientific literature from 1996-2011 conducted by the FDA. Our review of the literature during this time yields some different conclusions regarding the safety and efficacy of mesh use in prolapse repair. It may be useful to consider this information prior to making recommendations regarding mesh use in prolapse surgery according to the recent UPDATE.

Ajust single incision transobturator sling procedure for stress urinary incontinence: results after 1-year follow-up.

INTRODUCTION AND HYPOTHESIS: Data on the Ajust, a new single-incision sling procedure for female stress urinary incontinence (SUI) management, remain scarce and limited to a 1-year follow-up. Our goal was to assess the efficacy of this procedure after a 1-year follow-up. METHODS: This prospective evaluation involved 95 consecutive patients implanted with Ajust at a single centre. All patients had SUI on urodynamics due to urethral hypermobility, 33 % had preoperative overactive bladder (OAB) symptoms and none had detrusor overactivity. Ninety-two patients were treated on an outpatient basis, and 3 patients had general anaesthesia. Postoperative assessment was conducted at 1, 6, 12 months, and yearly thereafter. The main outcome measure was pad usage. Secondary parameters were self-reported SUI episodes, OAB symptoms, data of clinical examination, satisfaction using the Patient Global Impression of Improvement (PGI-I) scale, postoperative pain, and adverse events. RESULTS: After a mean follow-up of 21 ± 6 months (12-32), 76 out of 95 patients used no pads or one dry security pad, showing a success rate of 80 %. Seventy-nine out of 95 patients had no more SUI-related leakage. Only 6 patients experienced late recurrence of SUI after 6 months' follow-up. Perioperative complications included 1 case of vaginal hematoma, 1 case of acute urinary retention, 2 cases of urinary tract infection, all managed conservatively. Half of the patients had no pain after day 1, free of medications. Late complications were vaginal erosion in 1 case, and pain during exertion in 2 cases. CONCLUSIONS: The Ajust single incision transobturator sling is a safe and effective procedure, with durable results after 1 year.

A Search for Novel Risk Factors for Obstetric Anal Sphincter Injury.

OBJECTIVE: The objective of this study is to evaluate factors associated with obstetric anal sphincter injury and identify modifiable risks. METHODS: A retrospective case-control study was performed in women who gave birth at our institution between May 2008 and December 2012. Patients who had a third- or fourth-degree lacerations were compared with those who did not. Parity, stretch marks, age, body mass index, tobacco use, fetal weight, operative delivery, labor, and second stage duration were compared between groups. Multivariate direct logistic regression was conducted on all patients who had complete data to calculate the adjusted odds ratio. RESULTS: We identified 299 patients with third- or fourth-degree lacerations and 8,459 patients without third- or fourth-degree lacerations during the time frame. Duration of second stage between 1 hour and 2 hours (P < 0.0001), duration of second stage greater than 2 hours (P < 0.0001), midline or unknown type episiotomy (P < 0.0001), mediolateral episiotomy (P < 0.0001), vacuum delivery (P < 0.0001), forceps delivery (P < 0.0001), fetal weight greater than 4,000 g (P < 0.0001), and antepartum stress urinary incontinence (P < 0.006) were associated with a significant increase in high-risk lacerations. This study did not find a statistically significant association between parity and these lacerations. CONCLUSIONS: We, as others, found that episiotomy and operative delivery were modifiable risks of obstetrical care. Furthermore, even a short second stage of labor (1-2 hours) was associated with significant risk of injury.

Six-Month Outcomes of Reimplantation of a Coin-Sized Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome With Urgency Urinary Incontinence.

OBJECTIVE: The eCoin (Valencia Technologies Corporation, Valencia, CA) is a battery-powered, nickel-sized and shaped neuromodulation device for the treatment of overactive bladder, and it is implanted in the lower leg in a short office or outpatient procedure under local anesthesia. A follow-on trial was conducted to evaluate the feasibility, safety, and efficacy of eCoin reimplantation. METHODS: This was a prospective, single-arm, open-label study, including 23 participants with refractory urgency urinary incontinence (UUI) who were previously participants in the eCoin clinical feasibility trial. This follow-on study was conducted at 7 sites in the United States and New Zealand. Participants were reimplanted with a new eCoin device and activated after 4 weeks. Bladder diary data and validated quality-of-life instruments, collected at 12 weeks and 24 weeks postactivation, were compared with baseline. RESULTS: Participants of the study were considered responders if they reported a ≥ 50% reduction from baseline in episodes of UUI on a 3-day voiding diary. At 12 weeks of treatment, 74% (95% confidence interval [CI], 52%-90%) of participants were considered responders. At 24 weeks of treatment, 82% (95% CI, 60%-95%) of participants were considered responders with 36% (95% CI, 20%-57%) of participants achieving complete continence. There were no device-related serious adverse events reported during the study. CONCLUSIONS: The reimplantation of eCoin was both safe and effective in treating UUI associated with overactive bladder syndrome. The demonstrated significant reduction or resolution of symptoms with no serious safety concern suggests that eCoin is a convenient and maintainable therapeutic device.

Outcomes of a single trigone-only vs. 20 trigone-sparing injections of OnabotulinumtoxinA for refractory overactive bladder (OAB).

PURPOSE: To compare the safety and durability of a single intravesical trigonal-only versus 20 trigone-sparing injections of OnabotulinumtoxinA (BTA) for refractory OAB. METHODS: A chart review of all idiopathic OAB patients treated with BTA from January 2016 to December 2018 was performed. Outcomes measures included: inter-injection interval, post-void residual (PVR), urinary tract infections (UTI), urinary retention requiring catheterization, and procedure time (min). Statistical analyses were performed using independent sample t-tests. RESULTS: Baseline characteristics were comparable for the two groups, data on 69 treatments (19 patients trigone-only) were compared to 105 treatments (26 patients trigone-sparing). There were no differences in the inter-injection intervals or rates of UTI. The trigone-only group exhibited a lower mean PVR (113 ml vs 160 ml, p < 0.02), lower proportion with PVR > 150 ml (23% vs. 39%, p < 0.03), lower rate of urinary retention (5.3% vs. 17.4%, p < 0.02), and shorter procedure time (4.3 min vs. 5.7 min, p < 0.01). There were no cases of vesico-ureteral reflux. CONCLUSION: While interpretation remains speculative, the results of this observational study suggest that a single trigone-only injection appears to be as safe and durable as multiple trigone-sparing injections but maybe quicker to perform and appears to have a lower impact on voiding function. Larger series and adequately powered prospective randomized clinical trials are warranted to validate the findings of this pilot study.

Twelve-month Durability of a Fully-implanted, Nickel-sized and Shaped Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome with Urgency Urinary Incontinence: A Single-Arm, Prospective Study.

OBJECTIVES: To evaluate the safety and efficacy of the eCoin - a nickel-sized, primary battery-powered, neuromodulation device for the treatment of urgency urinary incontinence which is implanted in the lower leg in a 20-minute procedure under local anesthesia. A feasibility clinical trial was conducted and the results after 1 year of treatment with the eCoin are presented. METHODS: A total of 46 participants with refractory urgency urinary incontinence were included in this prospective, single-arm, open-label study. This study was conducted at 7 sites in the United States and New Zealand. Participants in this study were implanted with the eCoin in the lower leg over the tibial nerve and activated after 4 weeks. Bladder diary data and validated quality-of-life instruments, collected at 3, 6, and 12 months' post-activation, were compared to baseline values. RESULTS: Responders were defined as those who had a ≥50% reduction in reported episodes of urgency urinary incontinence. At 12 months', 65% of participants were considered responders with 26% of participants achieving complete continence. The median number of urgency urinary incontinence episodes per day decreased from 4.2 at baseline to 1.7 at 12 months'. Seventy percent of participants reported feeling "better", "much better", or "very much better" on the Likert 7-point maximum scale. One participant experienced a related serious adverse event. CONCLUSION: The eCoin is a safe and effective treatment for urgency urinary incontinence associated with overactive bladder syndrome, with significant reduction or complete resolution of symptoms and no significant safety concerns.

Predictive Value of Biomechanical Mapping for Pelvic Organ Prolapse Surgery.

OBJECTIVE: This study examined biomechanical changes in pelvic floor after urogynecological surgery. METHODS: This multisite clinical study was designed to explore changes in tissue elasticity, pelvic support, and certain functions (contractive strength, muscle relaxation speed, muscle motility) after pelvic organ prolapse (POP) surgery. A biomechanical mapping of the pelvic floor was performed before and 4 to 6 months after the surgery. The biomechanical data for 52 parameters were acquired by vaginal tactile imaging for manually applied deflection pressures to vaginal walls and pelvic muscle contractions. The two-sample t-test (P < 0.05) was used to test the null hypothesis that presurgery data in group 1 (positive parameter change after surgery) and presurgery data in group 2 (negative parameter change after surgery) belonged to the same distribution. RESULTS: A total of 78 subjects with 255 surgical procedures were analyzed across 5 participating clinical sites. All 52 t-tests for group 1 versus group 2 had P value in the range from 4.0 × 10-10 to 4.3 × 10-2 associating all of the 52 parameter changes after surgery with the presurgical conditions. The P value of before and after surgery correlation ranged from 3.7 × 10-18 to 1.6 × 10-2 for 50 of 52 tests, with Pearson correlation coefficient ranging from -0.79 to -0.27. Thus, vaginal tactile imaging parameters strongly correlated weak pelvic floor presurgery with the positive POP surgery outcome of improved biomechanical properties. CONCLUSIONS: Pelvic organ prolapse surgery, in general, improves the biomechanical conditions and integrity of the weak pelvic floor. The proposed biomechanical parameters can predict changes resulting from POP surgery.

Biomechanical mapping of the female pelvic floor: changes with age, parity and weight.

Quantitative biomechanical characterization of pelvic supportive structures and functions in vivo is thought to provide insight into the pathophysiology of pelvic floor disorders including pelvic organ prolapse (POP). An innovative approach - vaginal tactile imaging - allows biomechanical mapping of the female pelvic floor to quantify tissue elasticity, pelvic support, and pelvic muscle functions. The objective of this study is to explore an extended set of 52 biomechanical parameters to characterize pelvic floor changes with age, parity, and subject weight for normal pelvic floor conditions. 42 subjects with normal pelvic conditions (no POP, no stress urinary incontinence) were included in the data analysis from an observational, case-controlled study. The Vaginal Tactile Imager (VTI) was used with an analytical software package to automatically calculate 52 biomechanical parameters for 8 VTI test procedures (probe insertion, elevation, rotation, Val-salva maneuver, voluntary muscle contractions in 2 planes, relaxation, and reflex contraction). The ranges, mean values, and standard deviations for all 52 VTI parameters were established. 12 VTI parameters were identified as statistically sen-sitive (p < 0.05; t-test) to the subject age; 9 parameters were identified as statistically sensitive (p < 0.05; t-test) to the subject parity; no sensitivity was found to subject weight. Among the 12 parameters sensitive to women's age, 6 parameters show changes (decrease) in tissue elasticity and 6 parameters show weakness in pelvic muscle functions with age. Among the 9 parameters sensitive to parity, 5 parameters show changes (decrease) in tissue elasticity and 4 parameters show weakness in pelvic muscle functions after giving birth. The biomechanical mapping of the female pelvic floor with the VTI provides a unique set of parameters characterizing pelvic changes with age and parity. These objectively measurable biomechanical transformations of pelvic tissues, support structures, and functions may be used in future research and practical applications.