Printer Friendly

The Novel and Minimally Invasive Treatment Modalities for Female Pelvic Floor Muscle Dysfunction; Beyond the Traditional.

The pelvic floor, which comprises pelvic bone, muscles and connective tissue, supports and is vital for the normal functions of the pelvic organs, particularly the urinary bladder, urethra, rectum, and the reproductive system (1,2). Pelvic floor dysfunction (PFD) is a collection of complex clinical findings. The symptoms of PFD include pelvic pain, pressure, dyspareunia, stress urinary incontinence (SUI), incomplete urinary voiding, defecatory dysfunction, and pelvic organ prolapse (POP) (3). PFD is more common among females than among males and is often the result of vaginal childbirth (4,5). The other recognized major risk factors for PFD include age, obesity, menopause, and pregnancy (5,6). PFD affects the quality of life of patients and therefore is of great clinical importance (7). Surgical intervention remains the definitive treatment option for patients with symptomatic POP or SUI. In a large population-based study in the United States, the lifetime risk of any primary surgery for SUI or POP reaches 20% ages of 80 years women (8). The American Urology Association quotes a high percentage of 30% in patients undergoing surgery for SUI (9). Surgical and medical technologies in this field have rapidly advanced over the past two decades (10). Minimally invasive surgical options available to patients have expanded, and alternative and novel approaches, such as biological tissue fibrin materials and injectable biological agents (IBAs), have been developed to improve the management of SUI and POP secondary to PFD. Given the increased prevalence of obesity among the aging general population, PFD will become an ever-increasing presentation to uro-gynecologists and specialists of female urology. Minimally invasive treatments are therefore vital to improve the management of this growing cohort of patients.

Here, we describe the clinical presentation and assessment of patients presenting with SUI and POP and summarize the evidence for various alternative and minimally invasive approaches for PFD treatment. We have avoided focusing on traditional conservative treatments, namely pelvic floor exercises and the widely accepted practice of midurethral tape surgery, because these treatment modalities are well reported in current literature on PFD management.

STRESS URINARY INCONTINENCE

SUI is described as "the observation of involuntary leakage from the urethra, synchronous with exertion/effort, or on sneezing or coughing" (11). The prevalence of SUI increases among the female population with age. For example, the prevalence of SUI increases from 16% among women under 30 years to 29% among women aged 30-60 years old (12). Well-documented risk factors for the development of SUI include childbirth, childbirth mode, obesity, smoking, and age (13-16). Cesarean sections, a mode of childbirth, exert a protective effect on the pelvic floor reported by Al-Mufti et al. (17). Alternative differential diagnoses must be considered prior to embarking on treatment for SUI. Patients may also experience the symptoms of urge urinary incontinence (UUI) in addition to SUI. The clinician must correctly identify the predominant symptoms to provide the most appropriate treatment to patients with mixed urinary incontinence. UUI is often treated medically upon the first occurrence, whereas SUI often requires additional intervention (18). In addition to providing their clinical history, patients should also complete a bladder diary to assess their fluid intake and voiding habits, as well as the frequency of incontinence episodes. This assessment should be followed by a detailed physical examination, including neurological assessment (19). Pad tests and Q-tip tests can be useful in determining whether the patient will benefit from a urethral sling. Urodynamic studies can help confirm the patients' diagnosis, particularly prior to surgical intervention (20). Conservative options, mainly pelvic floor exercises and weight loss, are usually the first line of treatment for SUI. Other nonsurgical options include electrical and magnetic stimulation, duloxetine use, vaginal inserts (incontinence pessaries and tampons), and topical estrogens (21-23). Despite these treatments, as many as 30% of patients with SUI undergo surgical interventions (9). Various surgical techniques for SUI exist. These techniques include Burch retropubic colposuspension, tension-free vaginal tapes, transobturator tapes, midurethral slings, and minislings (24). Sling operations often require the use of prolene mesh devices (25). The use of paravaginal grafting techniques has also been reported (26). The increased scrutiny and additional restrictions received by the use of mesh devices (27) in the last decade highlight the need for novel and alternative treatments for the management of POP and SUI.

Stress Urinary Incontinence Treatments

Radiofrequency Denaturation

Radiofrequency denaturation is a nonsurgical technique that involves the insertion of a device into the urethra under local anesthesia. Radiofrequency energy is then applied to the bladder neck and proximal urethra to denature and promote the remodeling of collagen in the surrounding tissue (28). Patient outcomes were variable with reported "cure rates" of 22%-67% (29). A 3-year prospective study showed significant improvement in the patients' quality of life following treatment with RD but did not compare RD with other treatments (30).

A Cochrane systematic review concluded that insufficient evidence exists to determine whether RD improves the symptoms of SUI when compared with the sham treatment (31).

No evidence supports that RD is comparable with other established treatments for SUI, such as pelvic floor physiotherapy, pessaries, surgery, or IBAs. The recurrence of lower urinary tract symptoms within 3 years of treatment delivery has been reported, with dysuria being the most common complaint (29). Additional randomized controlled trials are needed to accurately determine the efficacy of RD in clinical practice.

Injectable Biological Agents

IBAs have been used for several decades. These materials are applied to increase tissue volume within the proximal urethral wall between the bladder neck and the external urethral sphincter. Increasing tissue volume at these locations increases urethral luminal coaptation and bladder outflow resistance (32). IBAs are delivered endoscopically with a cystoscope via needle injection into the periurethral area. The European Association of Urology guidelines recommend the use of IBAs for the temporary treatment of symptoms in patients who have failed conservative treatments for SUI. It can also be offered an alternative to a midurethral sling (33).

Various bulking agents have been developed and trialed. These IBAs include autologous fat, cross-linked collagen, graphite-coated zirconium beads, polytetrafluroethylene, silicon, dimethylsulfoxide and ethylene vinyl alcohol copolymers, hyaluronic acid, dextranomer microspheres, and calcium hydroxyapatite (34-36). Treatment with IBAs improves SUI symptoms by 18%-40% (28). The efficacy of IBAs is superior to that of pelvic floor physiotherapy but is inferior to that of surgical management (36). Collagen has been removed from the clinical arena but has been used as the standard reference for new agents in clinical trials (35). A Cochrane systematic review found that none of the new agents are inferior to collagen but have failed to reach a consensus on the superior agent or the effect of injection location within the urethra on patient outcomes (35). Novel IBAs (polyacrylamide hydrogel) have decreased patient incontinence episodes by 50% or greater in 53.2% of 12 months after treatment (37). IBAs may be cost effective in the initial treatment of patients with SUI without hypermobility or as a surgical adjunct. However, their long-term (greater than 15 months) economic viability is questionable when compared with that of traditional sling surgery for SUI (35). Common complications following the injection of IBAs include urinary retention (up to 30%) and urinary tract infection (up to 25%) (38). Rare complications include abscess formation following collagen injection and fat embolism after autologous fat injection (38).

Stem-cell Injections for Urethral Sphincter Restoration

This treatment aims to restore the external urethral sphincter through the injection of stem cells (often skeletal muscle-derived or adipose tissue-derived) into and around the sphincter (39). This treatment has been developed in animal models by Xu et al. (40), who successfully demonstrated the restoration of the urethral sphincter in a pudendal nerve-transected rat following the injection of muscle-based stem cells. Recently, a small phase-one clinical trial on the outcomes of the periurethral injection of stem cells has been reported. Arjmand et al. (41) reported favorable outcomes for women treated with autologous adipose-derived stem cells injected into the periurethral area for SUI (42). Core blood stem cells have been used by Lee et al. (42) with reasonable success (n=39) in female patients with SUI. Among these patients, 67% showed improvement at 12 months postinjection. Peters et al. (43) reported favorable outcomes following the injection of increasing doses of autologous muscle-derived stem cells into the urinary sphincter. However, several publications reported minimal improvement in voiding or in the results of urodynamic assessment, as well as the delayed onset of symptom improvement (44,45). This treatment modality remains in its infancy, with evidence to date being collected mainly from animal models and small-scale phase-one clinical trials. Ethical considerations and concerns regarding the regulatory control of stem-cell research have affected the expansion of this field (45).

Fibrin Sealant

Biocompatible fibrin glue is another endoscopic treatment for SUI that has existed since the 1990s (46,47). It involves the transvaginal placement of fibrin sealant to stimulate a fibrotic reaction, which elevates the vesicle--urethral junction. Data on the long-term outcomes of this treatment option remain lacking, with few published articles since the late 1990s.

Laparoscopic and Robotic-assisted Surgical Modalities

Open Burch colposuspension was the gold standard surgical technique for the management of SUI until the early 1990s (48). At 1 year postoperation, 85%-90% of patients are continent. This rate drops to 70% at 5 years postoperation. In 1991, Vancaillie and Schuessler (49) successfully reported the first laparoscopic Burch colposuspension. Following its introduction into clinical practice, laparoscopic treatment for SUI has become increasingly adopted, and evidence showing that its clinical outcomes are equivalent to that of colposuspension with the added benefits of minimally invasive surgery has accumulated. These benefits include reduced blood loss, length of hospital stay, postoperative pain, and catheterization period (50-52). Some authors have argued that laparoscopic colposuspension should be considered as the treatment of choice for women, especially young women, undergoing pelvic floor repair and concomitant retropubic surgery because it avoids the well-documented complications of mesh migration and erosion (53). Laparoscopic techniques for colposuspension using mesh and staples instead than the classical suturing technique have been described. A randomized controlled trial, however, has shown that this technique is associated with unfavorable outcomes (54). The challenging and most time-consuming aspect of laparoscopic colposuspension is the process of laparoscopic suturing in the pelvis. The development of robotic surgical systems has attempted to overcome this challenge (55). Robotic systems have revolutionized pelvic surgery, particularly uro-pelvic oncology. Three-dimensional-image displays and 720-degree robotic arm articulation have considerably facilitated suture-intensive procedures, such as laparoscopic colposuspension. Successful feasibility studies on the role of robotic-assisted surgery in SUI and voiding dysfunction after urogynaecological surgery have been conducted over the last 3-4 years (56,57). Modified single-series robotic-assisted approaches have been described in the contemporary literature with successful outcomes (58). No study has compared the outcomes of robotic-assisted techniques with either open or laparoscopic colposuspension. If benign urogynecological surgery follows the same trend as other pelvic surgical specialties, then robotic-assisted surgery for SUI is likely to become an increasing popular and cost effective technique in this specialty. SUI treatment modalities based on minimally invasive and laparoscopic and robotic interventions are summarized in Table 1. The published literature on novel techniques for the management of patients with SUI is presented in Table 2.

PELVIC ORGAN PROLAPSE

POP in females can be defined as the descent and/or herniation of pelvic organs from their normal anatomical location toward or through the vaginal opening. This condition can affect the patient's quality of life and sexual function (59). In females, the utero-sacral ligament, paravaginal attachments, and perineal body constitute the main parts of the system that supports pelvic organs and are interconnected with the endopelvic fascia (60). Any defect in this network may cause POP. Sacral nerve roots S2-4, via the pudendal nerve, are vitally important in the function of the pelvic floor. Defects in neurological communication in these nerves can interfere with the integrity of the pelvic organs and the function of the pelvic floor. Risk factors for the development of POP are similar to those for the development of SUI. Aging, multiparity, and obesity increase the prevalence of POP (61-63). Previous hysterectomy is also a risk factor for POP (63). Chronic constipation and ethnicity (Caucasian, followed by Latin-American, followed by Africa-American women in decreasing order of prevalence) have also been implicated in the development of POP (64,65). Many patients with POP are asymptomatic. However, symptomatic patients can present with a variety of symptoms that may be specifically related to prolapsed structures, such as a bulge or the sensation of pressure within the vagina. Other symptoms include lower urinary tract and defecatory or sexual dysfunction symptoms (63). POP and SUI symptoms considerably overlap (66). As with SUI, the patient's complete medical history must be collected and a thorough physical examination must be performed as part of the initial assessment of POP. POP is classified into four levels in accordance with the descriptions provided by The International Continence Society (67):

Level 1: Distal part of POP is up to 1 cm over the hymen.

Level 2: Distal part of POP is 1 cm or more over the hymen.

Level 3: Distal part of POP exceeds 1cm over the hymen and is less than 2 cm outside the body.

Level 4: Complete vaginal eversion.

Treatment options can be broadly divided into conservative or surgical options. Conservative measures include smoking cessation and lifestyle modifications (increased exercise, weight loss, and pelvic floor exercises) (68). Vaginal pessaries are widely used to successfully control symptoms with success rates of 50%-70% (69,70). Surgical treatments are offered to patients who have declined or failed conservative measures.

Most women with symptomatic POP that continues to persist despite conservative measures are treated through reconstructive procedures. Obliterated procedures are reserved for women who cannot tolerate major surgery or who are not sexually active.

Pelvic Organ Prolapse Treatment Options

Transvaginal Sacrospinous Ligament Suspension Stapled Fixation

In this surgical technique, the bilateral sacrospinous ligament is suspended by using surgical staples. It was first described in 1997 by Febbraro et al. (71) in a case series of 34 patients with levels 3 or 4 POP. The sacrospinous ligament suture fixation is a well-documented surgical treatment for POP, with acceptable complication rates and cure rates of 50%-100% (72). The cost of stapling devices is the limiting step in the technique described by Febbraro et al. (71) and when compared with a cheaper and equally effective existing technique, the stapled method is not cost effective.

Anterior Suturing Device

The use of a suturing device (Capio[R]) for the fixation of the sacrospinous ligament has been recently described. The device is a suture-performing system with a taper-cut needle and attached suture. The needle carrier is enclosed in the concave distal segment of the device's shaft. It is designed to allow the surgeon to drive and retrieve the suture in one step. In a comparative case series, Leone Roberti Maggiore et al. (73) found that traditional sutured fixation using the Capio[R] system reduced operative time and reduce blood loss while delivering comparable clinical outcomes at 3-year follow-up (73). Other observational series have also reported favorable outcomes, with reported cure rates of nearly 90% and only 10.6% POP recurrence (74).

Laparoscopic Sacrocolpopexy

Laparoscopic sacrocolpopexy was introduced in 1991 as an adaptation of the well-described open surgical approach. Open sacrocolpopexy was widely regarded as the gold-standard surgical treatment for POP with long-term success rates of 78%-100% (75). A randomized controlled trial by Freeman et al. (76) revealed clinical equivalence between open and laparoscopic sacrocolpopexy. Numerous retrospective case series have confirmed that the laparoscopic approach is a safe and effective alternative treatment for the surgical management of POP while conferring the well-documented advantages of minimally invasive surgery. Laparoscopic surgery has been shown to reduce surgical complications (7.7% for open and 4% for laparoscopic repair), pain, UTI rate, and urinary retention (75). Although reoperation rates for POP were higher in the laparoscopic group (5.7%) than in the open surgery group (3.8%), this difference was not statistically significant (p=0.29) (75). Similar findings have been reported by other authors (77,78) with excellent 5-year anatomical and functional outcomes being reported by Sarlos al. (79). As with any laparoscopic pelvic procedure, the main learning curve for the procedure centers on the mastery of laparoscopic suturing in the tight confines of the pelvis (80). As robotic-assisted surgery gathers momentum to address this challenge, the role of the "traditional" laparoscopic sacrocolpopexy may become limited.

Robotic-assisted Laparoscopic Sacrocolpopexy

The ever-expanding role of robotic-assisted procedures now includes sacrocolpopexy. The advantages of robotic-assisted pelvic procedures have been extensively reported in the literature (67,79). Robotic-assisted laparoscopic sacrocolpopexy (RAS) aims to overcome the lengthy learning curve associated with complex laparoscopic surgery. A large systematic review and meta-analysis of the published literature by Serati et al. (80) revealed that RAS is a safe and effective treatment option for patients with POP. When compared with open sacrocolpopexy, RAS increases operative time, but significantly reduces blood loss and length of hospital stay. Objective cure rates for RAS range from 84%-100% with the prolapse recurrence rate of 6.4% and reoperation rate of 3.3% (80). Interestingly, several articles have reported an overall cost benefit of RAS over open surgery. Figure 1 shows the dissection of tissues and placement of the mesh graft. Given that the mesh should not touch the bowel and intestine, surrounding tissues should be enclosed (Figure 2). A randomized controlled trial comparing RAS and open sacrocolpopexy showed that RAS does not significantly increase costs when the initial robot purchase and maintenance cost are excluded. Compared with laparoscopic sacrocolpopexy, RAS is associated with decreased blood loss and increased operative times (80). No significant difference exists between the clinical outcomes of RAS and laparoscopic sacrocolpopexy (80). POP treatment modalities based on minimally invasive and laparoscopic and robotic interventions are shown in Table 3. The published literature is summarized in Table 4. An awareness of alterative and novel treatments for PFD is crucial given the current controversy surrounding the use of mesh technology in uro-gynecological practice. Robotic-assisted surgery for SUI and POP is undergoing exponential development. The ability to offer a plethora of minimally invasive and nonsurgical techniques for the treatment of PFD has become increasingly necessary as the human population continues to age and individuals present with increasingly multiple medical comorbidities.

Editor-in-Chief's note: Ali Serdar Gozen is the member of the Editorial Board of Balkan Medical Journal. However, he did not take place at any stage on the editorial decision of the manuscript.

Conflict of Interest: No conflict of interest was declared by the authors.

Financial Disclosure: No financial disclosure was declared by the authors.

REFERENCES

(1.) Shelton AA, Welton ML. The pelvic floor in health and disease. West J Med 1997;167:90-8.

(2.) Cherry DA, Rothenberger DA. Pelvic floor physiology. Surg Clin North Am 1988;68:1217-30.

(3.) Keane DP, Sims TJ, Abrams P, Bailey AJ. Analysis of collagen status in premenopausal nulliparous women with genuine stress incontinence. Br J Obstet Gynaecol 1997;104: 994-8.

(4.) Thom D. Variations in estimates of urinary incontinence prevalence in the community: effects of differences in definition, population characteristics, and study type. J Am Geriatr Soc 1998;46:473-80.

(5.) Lal M, Pattison HM, Allan TF, Callender R. Postcesarean pelvic floor dysfunction contributes to undisclosed psychosocial morbidity. J Reprod Med 2009;54:53-60.

(6.) Snooks SJ, Swash M, Henry MM, Setchell M. Risk factors in childbirth causing damage to the pelvic floor innervation. Int J Colorectal Dis 1986;1:20-4.

(7.) Saboia DM, Firmiano MLV, Bezerra KC, Vasconcelos JA Neto, Oria MOB, Vasconcelos CTM. Impact of urinary incontinence types on women's quality of life. Rev Esc Enferm USP 2017;51:e03266.

(8.) Wu JM, Matthews CA, Conover MM, Pate V, Jonsson Funk M. Lifetime risk of stress urinary incontinence or pelvic organ prolapse surgery. Obstet Gynecol 2014;123:1201-6.

(9.) Dmochowski RR, Blaivas JM, Gormley EA, Juma S, Karram MM, Lightner DJ, et al. Update of AUA guideline on the surgical management of female stress urinary incontinence. J Urol 2010;183:1906-14.

(11.) Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, et al. The standardization of terminology in lower urinary tract function: report from the standardization sub-committee of the International Continence Society. Urology 2003;61:37-49.

(12.) Hampel C, Wienhold D, Benken N, Eggersmann C, Thuroff JW. Definition of overactive bladder and epidemiology of urinary incontinence. Urology 1997;50(6A Suppl):4-14.

(13.) Rortveit G, Daltveit AK, Hannestad YS, Hunskaar S; Norwegian EPINCONT Study. Urinary incontinence after vaginal delivery or caesarean section. N Engl J Med 2003;348:900-7.

(14.) Bump RC, McClish DK. Cigarette smoking and urinary incontinence in women. Am J Obstet Gynecol 1992;167:1213-8.

(15.) Dwyer PL, Lee ET, Hay DM. Obesity and urinary incontinence in women. Br J Obstet Gynaecol 1988;95:91-6.

(16.) Allen RE, Hosker GL, Smith AR, Warrell DW. Pelvic floor damage and childbirth: a neurophysiological study. Br J Obstet Gynaecol 1990;97:770-9.

(17.) Al-Mufti R, McCarthy A, Fisk NM. Obstetricians' personal choice and mode of delivery. Lancet 1996;347:544.

(18.) Dmochowski RR. Urinary incontinence: Proper assessment and available treatment options. J Womens Health (Larchmt) 2005;14:906-16.

(19.) Dywer PL, Rosamilia A. Evaluation and diagnosis of the overactive bladder. Clin Obstet Gynecol 2002;45:193-204.

(20.) Kohli N, Karram MM. Urodynamic evaluation for female urinary incontinence. Clin Obstet Gynecol 1998;41:672-90.

(21.) Hamann MF, Junemann KP, Naumann CM. Urinary incontinence in men and women: Diagnostics and conservative therapy. Urologe A 2014;53:1073-86.

(22.) Khan IJ, Tariq SH. Urinary incontinence: behavioural modification therapy in older adult. Clin Geriatr Med 2004;20:499-509.

(23.) Viera AJ, Larkins-Pettigrew M. Practical use of the pessary Am Fam Physician 2000;61:2719-26.

(24.) Cox A, Herschorn S, Lee L. Surgical management of female SUI: is there a gold standard? Nat Rev Urol 2013;10:78-89.

(25.) Agur W, Riad M, Secco S, Litman H, Madhuvrata P, Novara G, et al. Surgical treatment of recurrent stress urinary incontinence in women: a systematic review and meta-analysis of randomised controlled trials. Eur Urol 2013;64:323-36.

(26.) Jeppson PC, Sung VW. Autologous graft for treatment of midurethral sling exposure without mesh excision. Obstet Gynecol 2013;121(2 Pt 2 Suppl 1):437-9.

(27.) Chughtai B, Barber MD, Mao J, Forde JC, Normand ST, Sedrakyan A. Association Between the Amount of Vaginal Mesh Used with Mesh Erosions and Repeated Surgery After Repairing Pelvic Organ Prolapse and Stress Urinary Incontinence. JAMA Surg 2017;152:257-63.

(28.) Davila GW. Nonsurgical outpatient therapies for the management of female stress urinary incontinence: long-term effectiveness and durability. Adv Urol 2011;2011:176498.

(29.) Lukban JC. Transurethral radiofrequency collagen denaturation for treatment of female stress urinary incontinence: a review of the literature and clinical recommendations. Obstet Gynecol Int 2012;2012:384234.

(30.) Elser DM, Mitchell GK, Miklos JR, Nickell KG, Cline K, Winkler H, et al. Nonsurgical transurethral radiofrequency collagen denaturation: results at three years after treatment. Adv Urol 2011;2011:872057.

(31.) Kang D, Han J, Neuberger MM, Moy ML, Wallace SA, Alonso-Coello P, et al. Transurethral radiofrequency collagen denaturation for the treatment of women with urinary incontinence. Cochrane Database Syst Rev 2015:CD010217.

(32.) Frederick RW, Leach GE. Stress Urinary Incontinence Secondary to Intrinsic Sphincteric Deficiency. Vaginal Surgery for incontinence and prolapse. In: Zimmern PE, Norton PA, Haab F, Chapple CCR, editors. Springer-Verlag London Limited; 2006:118-23.

(33.) Lucas MG, Bosch RJL, Burkhard FC, Cruz F, Madden TB, Nambiar AK, et al. EAU Guidelines on Surgical Treatment of Urinary Incontinence. Eur Urol 2012;62:1118-29.

(34.) Haab F, Zimmern PE, Leach GE. Urinary stress incontinence due to intrinsic sphincteric deficiency: experience with fat and collagen periurethal injections. J Urol 1997;157:1283-6.

(35.) Kirchin V, Page T, Keegan PE, Atiemo KO, Cody JD, McClinton S, et al. Urethral injection therapy for urinary incontinence in women. Cochrane Database Syst Rev 2017;7:CD003881.

(36.) Mamut A, Carlson KV. Periurethral bulking agents for female stress urinary incontinence in Canada. Can Urol Assoc J 2017;11(6Suppl2):S152-S154.

(37.) Sokol ER, Karram MM, Dmochowski RR. Efficacy and safety of polyacrylamide hydrogel for the treatment of female stress incontinence: A randomized, prospective, multicentre North American study. J Urol 2014;192:843-9.

(38.) Matsuoka PK, Locali RF, Pacetta AM, Baracat EC, Haddad JM. The efficacy and safety of urethral injection therapy for urinary incontinence in women: a systematic review. Clinics (Sao Paulo) 2016;71:94-100.

(39.) Lee JY, Paik SY, Yuk SH, Lee JH, Ghil SH, Lee SS. Long term effects of muscle-derived stem cells on leak point pressure and closing pressure in rats with transected pudendal nerves. Mol Cells 2004;18:309-13.

(40.) Xu Y, Song YF, Lin ZX. Transplantation of muscle-derived stem cells plus biodegradable fibrin glue restores the urethral sphincter in a pudendal nervetransected rat model. Braz J Med Biol Res 2010;43:1076-83.

(41.) Arjmand B, Safavi M, Heidari R, Aghayan H, T Bazargani S, Dehghani S, et al. Concomitant Transurethral and Transvaginal-Periurethral Injection of Autologous Adipose Derived Stem Cells for Treatment of Female Stress Urinary Incontinence: A Phase One Clinical Trial. Acta Med Iran 2017;55:368-74.

(42.) Lee CN, Jang JB, Kim JY, Koh C, Baek JY, Lee KJ. Human cord blood stem cell therapy for treatment of stress urinary incontinence. J Korean Med Sci 2010;25:813-6.

(43.) Peters KM, Dmochowski RR, Carr LK, Robert M, Kaufman MR, Sirls LT, et al. Autologous Muscle Derived Cells for Treatment of Stress Urinary Incontinence in Women. J Urol 2014;192:469-76.

(44.) Kuismanen K, Sartoneva R, Haimi S, Mannerstrom B, Tomas E, Miettinen S, et al. Autologous adipose stem cells in treatment of female stress urinary incontinence: results of a pilot study. Stem Cells Transl Med 2014;3:936-41.

(45.) Aragon IM, Imbroda BH, Lara MF. Cell Therapy Clinical Trials for Stress Urinary Incontinence: Current Status and Perspectives Int J Med Sci 2018;15:195-204.

(46.) Falconer C, Larsson B. New and simplified vaginal approach for correction of urinary stress incontinence in women. Neurourol Urodyn 1995;14:365-70.

(47.) Killholma P, Haarala M, Polvi H, Makinen J, Chancellor MB. Sutureless endoscopic colposuspension with fibrin sealant. Tech Urol 1995;1:81-3.

(48.) Lapitan MC, Cody JD. Open retropubic colposuspension for urinary incontinence in women. Cochrane Database Syst Rev 2016;2:CD002912.

(49.) Vancaillie TG, Schuessler W. Laparoscopic bladder neck suspension. J Laparoendosc Surg 1991;1:169-73.

(50.) Reid F, Smith AR. Laparoscopic versus open colposuspension: which one should we choose? Curr Opin Obstet Gynecol 2007;19:345-9.

(51.) Hong JH, Choo MS, Lee KS. Long-term results of laparoscopic Burch colposuspension for stress urinary incontinence in women. J Korean Med Sci 2009;24:1182-6.

(52.) Dean NM, Ellis G, Wilson PD, Herbison GP. Laparoscopic colposuspension for urinary incontinence in women. Cochrane Database Syst Rev 2006:CD002239.

(53.) Jenkins TR, Liu CY. Laparoscopic Burch colposuspension. Curr Opin Obstet Gynecol 2007;19:314-8.

(54.) Ankardal M, Milsom I, Stjerndahl JH, Engh ME. A three-armed randomized trial comparing open Burch colposuspension using sutures with laparoscopic colposuspension using sutures and laparoscopic colposuspension using mesh and staples in women with stress urinary incontinence. Acta Obstet Gynecol Scand 2005;84:773-9.

(55.) Singh I, Hemal AK. Role of robot-assisted pelvic surgery. Scientific World Journal 2009;9:479-89.

(56.) Orasanu B, Marotte J, Pasko B, Hijaz A, Daneshgari F. Robotic-assisted urethrolysis for urethral obstruction after retropubic bladder neck suspension-a case series report. J Endourol 2014;28:214-8.

(57.) Francis SL, Agrawal A, Azadi A, Ostergard DR, Deveneau NE. Robotic Burch colposuspension: a surgical case and instructional video. Int Urogynecol J 2015;26:147-8.

(58.) Bora GS, Gupta VG, Mavuduru RS, Devana SK, Singh SK, Mandal AK. Robotic Burch colposuspension-modified technique. J Robot Surg 2017;11:381-2.

(59.) Lowder JL, Ghetti C, Nikolajski C, Oliphant SS, Zyczynski HM. Body image perceptions in women with pelvic organ prolapse: a qualitative study. Am J Obstet Gynecol 2011;204:441.

(60.) Barber MD. Contemporary views on female pelvic anatomy. Cleve Clin J Med 2005;72(Suppl 4):3-11.

(61.) Nygaard I, Barber MD, Burgio KL, Kenton K, Meikle S, Schaffer J, et al. Prevalence of symptomatic pelvic floor disorders in US women. JAMA 2008;300:1311-6.

(62.) Boyles SH, Weber AM, Meyn L. Procedures for pelvic organ prolapse in the United States, 1979-1997. Am J Obstet Gynecol 2003;188:108-15.

(63.) Jelovsek JE, Maher C, Barber MD. Pelvic organ prolapse. Lancet 2007;369:1027-38.

(64.) Weber AM, Walters MD, Ballard LA, Booher DL, Piedmonte MR. Posterior vaginal prolapse and bowel function. Am J Obstet Gynecol 1998;179:1446-9.

(65.) Whitcomb EL, Rortveit G, Brown JS, Creasman JM, Thom DH, Van Den Eeden SK, Subak LL. Racial differences in pelvic organ prolapse. Obstet Gynecol 2009;114:1271-7.

(66.) Ignjatovic I, Stojkovic I, Basic D, Medojevic N, Potic M. Optimal primary minimally invasive treatment for patients with stress urinary incontinence and symptomatic pelvic organ prolapse: tension free slings with colporrhaphy, or Prolift with the tension free mid-urethral sling? Eur J Obstet Gynecol Reprod Biol 2010;150:97-101.

(67.) Swift S. Current opinion on the classification and definition of genital tract prolapse. Curr Opin Obstet Gynecol 2002;14:503-7.

(68.) Culligan PJ. Nonsurgical management of pelvic organ prolapse. Obstet Gynecol 2012;119:852-60.

(69.) Panman CM, Wiegersma M, Kollen BJ, Burger H, Berger MY, Dekker JH. Predictors of unsuccessful pessary fitting in women with prolapse: a cross-sectional study in general practice. Int Urogynecol J 2017;28:307-13.

(70.) Deng M, Ding J, Ai F, Zhu L. Successful use of the Gellhorn pessary as a second-line pessary in women with advanced pelvic organ prolapse. Menopause 2017;24:1277-81.

(71.) Febbraro W, Beucher G, Von Theobald P, Hamel P, Barjot P, Heisert M, et al. Feasibility of bilateral sacrospinous ligament vaginal suspension with a stapler. Prospective studies with the 34 first cases. J Gynecol Obstet Biol Reprod (Paris) 1997;26:815-21.

(72.) Tseng LH, Chen I, Chang SD, Lee CL. Modern role of sacrospinous ligament fixation for pelvic organ prolapse surgery a systemic review. Taiwan J Obstet Gynecol 2013;52:311-7.

(73.) Leone Roberti Maggiore U, Alessandri F, Remorgida V, Venturini PL, Ferrero S. Vaginal sacrospinous colpopexy using the Capio suture-capturing device versus traditional technique: feasibility and outcome. Arch Gynecol Obstet 2013;287:267-74.

(74.) Vaudano G, Gatti M. Correction of vaginal vault prolapse using Capio[TM] suture capturing device: our experience. Minerva Ginecol 2015;67:103-11.

(75.) Khan A, Alperin M, Wu N, Clemens JQ, Dubina E, Pashos CL, et al. Comparative outcomes of open versus laparoscopic sacrocolpopexy among Medicare beneficiaries. Int Urogynecol J 2013;24:1883-91.

(76.) Freeman RM, Pantazis K, Thomson A, Frappell J, Bombieri L, Moran P, et al. A randomised controlled trial of abdominal versus laparoscopic sacrocolpopexy for the treatment of post-hysterectomy vaginal vault prolapse: LAS study. Int Urogynecol J 2013;24:377-84.

(77.) Granese R, Candiani M, Perino A, Romano F, Cucinella G. Laparoscopic sacrocolpopexy in the treatment of vaginal vault prolapse: 8-years' experience. Eur J Obstet Gynecol Reprod Biol 2009;146:227-31.

(78.) Price N, Slack A, Jackson SR. Laparoscopic sacrocolpopexy: an observational study of functional and anatomical outcomes. Int Urogynecol J 2011;22:77-82.

(79.) Sarlos D, Kots L, Ryu G, Schaer G. Long-term follow-up of laparoscopic sacrocolpopexy. Int Urogynecol J 2014;25:1207-12.

(80.) Serati M, Bogani G, Sorice P, Braga A, Torella M, Salvatore S, et al. Robot-assisted Sacrocolpopexy for Pelvic Organ Prolapse: A Systematic Review and Meta-analysis of Comparative Studies. Eur Urol 2014;66:303-18.

Yigit Akyn (1), Matthew Young (2), Muhammad Elmussareh (2), Nickolaus Charalampogiannis (3), Ali Serdar Gozen (3)

(1) Department of Urology, Yzmir Katip Celebi University School of Medicine, Yzmir, Turkey

(2) Clinic of Urology, Mid Yorkshire Hospitals NHS Trust, Wakefield, The United Kingdom

(3) Department of Urology, SLK-Kliniken Heilbronn, University of Heidelberg, Heilbronn, Germany

Address for Correspondence: Dr. Ali Serdar Gozen, Department of Urology, SLK-Kliniken Heilbronn, University of Heidelberg, Heilbronn, Germany

e-mail: ali.goezen@slk-kliniken.de

ORCID ID: orcid.org/0000-0002-9975-443X

Received: 4 May 2018

Accepted: 21 June 2018 * DOI: 10.4274/balkanmedj.2018.0869

Cite this article as:

Akyn Y, Young M, Elmussareh M, Charalampogiannis N, Gozen AS. The Novel and Minimally Invasive Treatment Modalities for Female Pelvic Floor Muscle Dysfunction; Beyond the Traditional. Balkan Med J 2018;35:358-66
TABLE 1. Stress urinary incontinence treatments based on minimally
invasive and laparoscopic and robotic interventions

Interventions                                            Success rate

Radiofrequency denaturation                              22%-67%
Injectable bulking agents                                21%-67%
Stem-cell injections for urethral sphincter restoration  67%
Fibrin sealant                                           63%
Laparoscopic and robotic-assisted surgical modalities    69%-100%

TABLE 2. Summary of the literature reviewed related to novel techniques
for the management of stress urinary incontinence

Author/year                  Study design         Number of patients
                                                  (if applicable) and
                                                  follow-up

Radiofrequency denaturation
  Lukban (29)                Literature review    N/A
  Elser et al. (30)          Prospective          n=139
                             observational        36-month follow-up
                             study
Kang et al. (31)             Systematic review    n=173
                                                  included sham-RCT
Injectable bulking agents
                             Literature review    N/A
  Davila (28)
  Haab et al. (34)           Prospective          n=67
                             observational        7-month follow-up
                             study

  Kirchin et al. (35)        Systematic review    n=2004 in 14 trials


  Mamut and Carlson (36)     Literature review    N/A




  Sokol et al. (37)          Single-blinded       n=345

  Matsuoka et al. (38)       randomized           12-month follow-up
                             controlled
                             trial

Stem-cell injections for urethral sphincter restoration
  Arjmand et al. (41)        Observational        n=10
                             prospective          24-week follow-up
                             series

  Lee et al. (42)            Observational        n=39
                             prospective          12-month follow-up
                             series
  Peters et al. (43)         Prospective          n=80
                             clinical  trial      12-month follow-up
                             with varying doses
                             of stem cells
  Kuismanen et al. (44)      Case series          n=5
                                                  12-month follow-up


  Aragon et al. (45)         Literature review    n=577



Fibrin sealant
  Falconer and Larsson (46)  Case series          n=24
                                                  At least 18 months
                                                  of follow-up
  Killholma et al. (47)      Case series          n=17
                                                  12/17 followed up
                                                  for>6 month
Laparoscopic and robotic-assisted surgical modalities
  Reid and Smith (50)        Literature review    n=491
                             of two large         24 month follow-up
                             randomized
                             controlled trials
  Hong et al. (51)           Prospective          n=68
                             observational        Mean follow-up 52
                             study                months
  Dean et al. (52)           Systematic review    21 trials with sample
                                                  sizes ranging from
                                                  n=20-300

  Jenkins and Liu (53)       Literature review    N/A



  Ankardal et al. (54)       Three-arm            n=211
                             prospective          12 months follow-up
                             randomized
                             controlled
                             trial-open,
                             laparoscopic
                             (sutures),
                             laparoscopic
                             (mesh/staples)
  Orasanu et al. (56)        Case series          n=6
  Francis et al. (57)        Case report          n=1

  Bora et al. (58)           Case report          n=1


Author/year                  Conclusions



Radiofrequency denaturation
  Lukban (29)                Cure rate of 22%-67%
  Elser et al. (30)          62% reported at least 50% reduction in
                             leakage at 36 months
                             78% reported improved quality of life
Kang et al. (31)             Insufficient evidence to show improved QoL

Injectable bulking agents
                             18%-40% reported symptom improvement
  Davila (28)                following IBA treatment
  Haab et al. (34)           13% of patients treated with fat reported
                             "cured"
                             24% of patients treated with collagen
                             reported "cured"
  Kirchin et al. (35)        Insufficient evidence to guide practice
                             Treatment results are not sustained over
                             the long-term
  Mamut and Carlson (36)     Clinical efficacy and durability of IBAs
                             are not as good as those of surgical
                             approaches Nevertheless, IBAs are a useful
                             alternative for patients wishing to avoid
                             surgery
  Sokol et al. (37)          Hydrogel is as effective as collagen for
                             SUI treatment
  Matsuoka et al. (38)       Lack of long-term studies support that the
                             effect of IBA usage diminishes over time
                             A safe treatment
                             Additional RCTs are required
Stem-cell injections for urethral sphincter restoration
  Arjmand et al. (41)        Reduced SUI at 2, 6, and 24 weeks



  Lee et al. (42)            67% patients reported >50% improvement in
                             symptoms at 12 months

  Peters et al. (43)         UDI-6 and IIQ-7 at 12 months in all dose
                             groups showed significant improvement from
                             baseline values

  Kuismanen et al. (44)      At 6 months, 1/5 had negative cough-test
                             results
                             At 12 months, 3/5 had negative cough-test
                             results
  Aragon et al. (45)         No consensus on the best source of stem
                             cells for SUI treatment
                             Stem cells are flexible and safe
                             Additional RCTs are needed
Fibrin sealant
  Falconer and Larsson (46)  63% reported subjective improvement


  Killholma et al. (47)      10 patients were completely dry
                             2 patients reported "marked improvement"


  Reid and Smith (50)        No significant difference between the
                             surgical outcomes of open and laparoscopic
                             surgery at 24 months

  Hong et al. (51)           Subjective cure rate of 72%


  Dean et al. (52)           Laparoscopic approach is as good as open
                             surgery at 24 months
                             Laparoscopic enabled quick recovery but
                             prolonged operative time
  Jenkins and Liu (53)       Laparoscopic approach is an effective
                             treatment for SUI and provides outcomes
                             that are equivalent to those of open
                             surgery
  Ankardal et al. (54)       Laparoscopic approach reduced blood loss.
                             Objective cure rates better with suture
                             (open or laparoscopic) than those with
                             mesh/staples
                             Open surgery is rapid
                             Laparoscopic approach with mesh/staples
                             reduced length of stay and catheter
                             duration

  Orasanu et al. (56)        5/6 had complete symptom resolution
  Francis et al. (57)        Robotic approach is a safe and effective
                             treatment for SUI
  Bora et al. (58)           Robotic approach is a safe and effective
                             treatment for SUI

IBA: injectable biological agents; IIQ: incontinence impact
questionnaire; N/A: not applicable; RCT: randomized controlled trial;
SUI: stress urinary incontinence; QoL: quality of life; UDI: urogenital
distress inventory

TABLE 3. Pelvic organ prolapse treatment modalities based on minimally
invasive and laparoscopic and robotic interventions

Interventions                                 Success rate

Transvaginal sacrospinous ligament            50%-100%
suspension stapled fixation
Anterior suturing device                      90%
Laparoscopic sacrocolpopexy                   78%-100%
Robotic-assisted laparoscopic sacrocolpopexy  84%-100%

TABLE 4. Summary of the literature reviewed related to novel techniques
for the management of patients with pelvic organ prolapse

Author/year               Study design           Number of patients
                                                 (if applicable) and
                                                 follow-up

Transvaginal sacrospinous ligament suspension stapled fixation

  Febbraro et al. (71)    Prospective            n=37
                          case series            Mean follow-up of 19
                                                 months
  Tseng et al. (72)



Anterior suturing device
  Leone Roberti           Comparative case       n=86
  Maggiore et al. (73)    series                 3-year follow-up

  Vaudano and Gatti (74)  Observational          n=47
                          retrospective study    Mean follow-up 18.5
                                                 months
Laparoscopic sacrocolpopexy
  Khan et al. (75)        Systematic review      n=970


  Freeman et al. (76)     Randomized controlled
                          trial

  Granese et al. (77)     Prospective            n=165
                          observational study    Mean follow-up of 43
                                                 months
  Price et al. (78)       Retrospective          n=84
                          observational study
  Sarlos et al. (79)      Prospective            n=101
                          observational study    5-year follow-up

Robotic-assisted laparoscopic sacrocolpopexy
  Serati et al. (80)      Systematic review      n=1488 from 27
                                                 studies

Author/year               Conclusions



Transvaginal sacrospinous ligament suspension stapled fixation

  Febbraro et al. (71)    77% had a perfect anatomical result
                          1/37 experienced POP recurrence

  Tseng et al. (72)       This treatment is a safe and well-documented
                          option for POP
                          It can facilitate concurrent pelvic floor
                          repair
Anterior suturing device
  Leone Roberti           No difference in the postoperative
  Maggiore et al. (73)    complication rates and surgical outcomes of
                          the two modalities
  Vaudano and Gatti (74)  89.3% subjective cure rate
                          5/47 experienced POP recurrence

Laparoscopic sacrocolpopex
  Khan et al. (75)        Laparoscopic approach increased reoperative
                          rates and increased mesh-related
                          complications if combined with hysterectomy
  Freeman et al. (76)     Equivalent clinical outcomes between both
                          approaches but laparoscopic surgery reduced
                          length of stay and blood loss
  Granese et al. (77)     Anatomical success in 94.9%
                          5.1% experienced POP recurrence

  Price et al. (78)       100% of patients objectively reported "good"
                          vault support on the POP-Q
  Sarlos et al. (79)      Subjective cure rate of 95.3% at 5 years
                          11 anatomical recurrences
                          Reoperation rate of 3.5%
Robotic-assisted laparoscopic sacrocolpopexy
  Serati et al. (80)      Objective cure rate of 84%-100%
                          Subjective cure rate of 92%-95%
                          Most cost-effective approach was
                          laparoscopic, followed by robotic, then open

N/A: not applicable; POP: pelvic organ prolapse
COPYRIGHT 2018 Galenos Yayinevi Tic. Ltd.
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2018 Gale, Cengage Learning. All rights reserved.

Article Details
Printer friendly Cite/link Email Feedback
Author:Akyn, Yigit; Young, Matthew; Elmussareh, Muhammad; Charalampogiannis, Nickolaus; Gozen, Ali Serdar
Publication:Balkan Medical Journal
Article Type:Report
Date:Sep 1, 2018
Words:6582
Previous Article:Sex as a Biological Variable in Research: the New Policy of Balkan Medical Journal.
Next Article:Central Auditory Processing Disorders in Individuals with Autism Spectrum Disorders.
Topics:

Terms of use | Privacy policy | Copyright © 2021 Farlex, Inc. | Feedback | For webmasters