Clinical Research Directory

A Novel Laparoscopic Apical Promontofixation Technique With Simultaneous Perineal Reconstruction for Patients With Symptomatic Pelvic Organ Prolapse

Pelvic organ prolapse in women is a common gynecological condition worldwide, with prevalence reported by different authors ranging from 15% to 50%. Up to 20% of women require surgical intervention during their lifetime due to genital prolapse or urinary incontinence. Surgical correction of prolapse provides an immediate effect by restoring the anatomical and physiological position of the pelvic organs, while also improving women's daily quality of life. Approximately 80-90% of women report satisfaction with the outcomes of prolapse surgery. However, there is still no global consensus regarding the optimal technique for performing colposacropexy. Multiple surgical approaches are currently in use, which prevents a definitive evaluation of the best method for surgical management of this condition. The classical laparoscopic sacrocolpopexy technique, while effective, does not eliminate the risk of mesh-related complications, particularly when synthetic implants are placed along the full length of the anterior and posterior vaginal walls. Therefore, there is a strong rationale for developing a novel, simplified surgical approach for prolapse correction, derived from the original laparoscopic apical promontofixation, with simultaneous correction of cystocele and rectocele. This could potentially improve surgical outcomes for patients with pelvic organ prolapse while reducing the risk of complications associated with synthetic mesh implantation.

Evaluation of the Efficacy in Increasing Sexual Arousal, Safety and Tolerability of BZ371A in Women With Sexual Arousal Disorder

Evaluation of the efficacy in increasing sexual arousal, safety and tolerability of BZ371A in gel form applied to women with sexual arousal disorder

Effect of Respiratory Exercises With Pelvic Floor Rehab on Dyspareunia & Autonomic Function in Women

Background and Aim: Dyspareunia, or pain during sexual intercourse, is a common component of female sexual dysfunction and may have multifactorial origins, including musculoskeletal and autonomic factors. While pelvic floor rehabilitation is an established treatment approach for musculoskeletal dyspareunia, it may not sufficiently address the autonomic dysregulation commonly observed in chronic pain conditions. The aim of this study is to investigate the effects of adding diaphragmatic breathing exercises and diaphragm manual therapy to standard pelvic floor rehabilitation on pain severity, pelvic floor function, and autonomic nervous system regulation in women diagnosed with musculoskeletal-origin dyspareunia. Methods: This randomized controlled clinical trial will be conducted between September 1, 2025, and December 1, 2025, at the Kurbaa Training and Consultation Center in Istanbul. A total of 45 participants aged 18-45 years who meet the inclusion criteria will be randomly assigned into three equal groups (n = 15): Group I: Pelvic floor rehabilitation only Group II: Pelvic floor rehabilitation + diaphragmatic breathing exercises Group III: Pelvic floor rehabilitation + diaphragmatic breathing exercises + diaphragm manual therapy Interventions will be administered once per week for 8 weeks. Pre- and post-intervention assessments will include pain intensity (Visual Analog Scale), pelvic floor muscle function (ultrasonography), sexual function (Female Sexual Function Index), anxiety level (Beck Anxiety Inventory), and autonomic regulation (Heart Rate Variability using Elite HRV). Statistical analyses will be performed using SPSS with significance set at p \< 0.05. Expected Contribution: This study is expected to contribute to the development of more comprehensive treatment protocols for dyspareunia by integrating physical and neurophysiological rehabilitation components. It may also provide evidence supporting the role of autonomic regulation in improving treatment outcomes for female sexual pain disorders.

Developing a Clinical Practice Guideline With The Delphi Technique for Evaluation and Counseling of Women's Sexual Health

Type of Research The research will be conducted prospectively and methodologically. The Delphi Technique, one of the qualitative research methods, will be used. Location and Time of Research Data collection will take place between April 12, 2023, and June 12, 2024, at universities, non-governmental organizations (NGOs) operating in the field of sexual health, and hospitals located in Istanbul. Population and Sample of the Research A purposive sampling method will be used to select the participant group. Experts in sexual health working in universities, counseling centers, private and public hospitals, including nurses, physicians, psychologists, and academicians, as well as women with and without sexual dysfunction, will be included in the expert opinion team. The ideal group size for the Delphi technique is reported to be 10-20 experts, with a minimum of 7, although this number may vary depending on the subject (Şahin, 2001). In this study, the target is to include 15 participants from each group, representing different fields, for a total of 90 participants. Data Collection Before data collection, approval will be obtained from the Istanbul University-Cerrahpaşa Non-Interventional Clinical Research Ethics Committee and institutional permission from the Istanbul University-Cerrahpaşa, Cerrahpaşa Medical Faculty Hospital, Gynecology and Obstetrics Polyclinic. The research will consist of two main stages. In the first stage, a clinical practice guide for evaluating and counseling women's sexual health will be created using the Delphi technique. In the second stage, the guide will be made available, and feedback will be collected from practitioners and women regarding the guide. The Delphi technique, which will be used in the first stage, is a valid and reliable data collection method that systematically gathers expert opinions. It also allows for consensus to be reached in cases where there are differences of opinion. One of the applications of the Delphi technique is the development of standards. Clinical Practice Guidelines are developed worldwide using three different Delphi methods: de novo, translated guides, and adaptation. In this study, the de novo Delphi method is planned to be used. The de novo guideline development method is employed when no previous guideline exists for the field of study or when existing guidelines have lost their validity. This method includes steps such as selecting the topic, forming working groups, preparing a draft guideline based on evidence and recommendations, presenting the draft to expert opinion, publishing the final guideline, delivering it to the target audience, and re-evaluating and updating it. In this study, instead of the classical Delphi technique, the E-Delphi technique will be used with the help of electronic communication tools. The research, which will be completed after three Delphi sessions, will involve contacting participants via email and telephone. In the first stage, experts will be identified, and face-to-face meetings will be conducted with participants for introductions. The participants' views on evaluating women's sexual health and sexual health care standards will be collected over three separate sessions using the Delphi method. In the second stage, the guide created will be provided to healthcare workers, and it will be expected that the sexual health of women with and without sexual dysfunction will be evaluated and counseled according to this guide. Feedback from practitioners and women regarding the guide will be collected during this stage. This pilot study will be applied to 10 healthcare workers and 10 women with and without sexual dysfunction. Participants' views on the guide will be evaluated using the "Guide Satisfaction Survey (Appendix-4)." Data Collection Tool Separate data collection tools will be used for each of the three Delphi sessions. In the first Delphi session, the "I. Delphi Survey (Appendix-2)" will include open-ended questions addressing the research problem and demographic information. Participants will also receive the "Invitation Text (Appendix-1)" and "Informed Consent Form (Appendix-3)" containing general information about the study process and the Delphi technique. In the second Delphi session, suggestions from the I. Delphi Survey and a literature review conducted before the sessions will be used to create standard items. These items will be compiled into a Likert-type survey, called the "II. Delphi Survey," designed to gather participants' opinions on the created items and determine their level of agreement. Participants will also be asked to add any new items, comments, or suggestions they may have. In the third Delphi session, standard items resulting from the evaluation of data from the second Delphi session will be compiled into a Likert-type su