Pelvic Organ ProlapseNCT06631508
Effects of a Follow-up Based Nursing Care Protocol on Pelvic Organ Prolapse
A study testing Follow-up-based Nursing Care Protocol in people with Pelvic Organ Prolapse, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to evaluate the effects of a follow-up-based nursing care protocol-implemented during the perioperative and post-discharge home care processes-on pelvic organ prolapse symptoms, quality of life, and sexual functions in women who underwent surgery for pelvic organ prolapse. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Follow-up-based Nursing Care Protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2023to 15 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being stage ≥2 according to POP Classification (POP-Q),
- Being between 30-65 years old,
- Being sexually active,
- Ability to read and write,
- Ability to speak Turkish,
- Ability to use phone
- Having a phone that can be reached at all times and
- Agreeing to participate in the study
Who cannot join
- Being stage <2 according to POP Classification (POP-Q),
- Being between <30 and >65 years of age,
- Not being sexually active,
- Not being able to read and write,
- Not being able to speak Turkish,
- Inability to use the phone
Show all 9Show fewer
- Not having a phone that can be reached at all times and
- Not agreeing to participate in the study
- Discontinue the research for any reason
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gulhane Training and Research Hospital
Ankara, Ankara
About this study
Official title: Evaluation of the Effect of a Follow-up Based Nursing Care Protocol Developed for Women With Pelvic Organ Prolapse on Quality of Life and Sexual Functions
The goal of this clinical trial is to evaluate the effects of a follow-up-based nursing care protocol-implemented during the perioperative and post-discharge home care processes-on pelvic organ prolapse symptoms, quality of life, and sexual functions in women who underwent surgery for pelvic organ prolapse.
The main questions it aims to answer are:
Is the follow-up-based nursing care protocol effective in reducing pelvic organ prolapse symptoms and improving quality of life and sexual functions? What are the comparative outcomes between the intervention group (receiving video-supported education and structured follow-ups at 2 weeks, 6 weeks, 3 months, and 6 months) and the control group (receiving routine perioperative nursing care)? Researchers will compare the intervention and control groups to determine the impact of the nursing care protocol on patients' recovery, quality of life, and symptom scores over a 6-month period.
Read the detailed description
In order to maintain holistic care, maintaining communication with the individual after discharge and providing individual counseling regarding the problems experienced have an important place in patient follow-up. In this context, perioperative consultancy should be provided under nurse management to make it easier for patients to cope with physical and psychosocial problems, improve quality of life and ensure continuity of care. Therefore, this randomized controlled trial was conducted to evaluate the effects of a follow-up-based nursing care protocol-implemented during the perioperative and post-discharge home care processes-on pelvic organ prolapse symptoms, quality of life, and sexual functions in women who underwent surgery for pelvic organ prolapse.
The study was carried out at the Gülhane Training and Research Hospital, Department of Obstetrics and Gynecology Clinic between October 15, 2023, and June 15, 2025. The sample of the research consisted of a total of 106 women who met the inclusion criteria (54 in the intervention group and 52 in the control group).
During the initial meeting, the Introductory Characteristics Form, Prolapse Quality of Life Questionnaire, Pelvic Organ Prolapse Symptom Score, Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire, Preoperative Period Patient Assessment Form, and Pelvic Organ Prolapse Nursing Diagnoses List were administered to all participants.
The intervention group received education via Preoperative and Post-discharge Home Follow-up Training Videos, and follow-up interviews were conducted at the 2nd week (1st follow-up), 6th week (2nd follow-up), 3rd month (3rd follow-up), and 6th month (4th follow-up) post-discharge. The control group received routine perioperative nursing care, with follow-up interviews conducted at the same intervals (2nd week, 6th week, 3rd month, and 6th month). At the final follow-up (6th month), both groups were administered the Prolapse Quality of Life Questionnaire, Pelvic Organ Prolapse Symptom Score, Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire, Post-discharge Patient Assessment Form, Pelvic Organ Prolapse Nursing Diagnoses List, and the Satisfaction Scale.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Follow-up-based Nursing Care Protocol, Control Group: Routin Care
- Keywords
- pelvic organ prolapse, perioperative care, follow up protocol, nursing care
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow-up-based Nursing Care ProtocolBehavioural
Patients in the intervention group received a structured follow-up-based nursing care protocol. They were shown preoperative and post-discharge home follow-up training videos. Post-discharge follow-up interviews and counseling were systematically conducted at the 2nd week (1st follow-up), 6th week (2nd follow-up), 3rd month (3rd follow-up), and 6th month (4th follow-up) to evaluate symptoms, quality of life, and sexual functions.
Control Group: Routin CareOther
Patients in the control group received routine perioperative nursing care. No special educational videos or structured follow-up protocols were administered by the researcher. Data were collected during the perioperative period and via routine telephone follow-ups at the designated intervals.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group: Follow-up Nursing Care Protocol | Experimental | Follow-up Group: Patients received a follow-up-based nursing care protocol, including preoperative and post-discharge educational videos, structured telephone follow-ups at 2 weeks, 6 weeks, 3 months, and 6 months, and individual counseling. Receives: Behavioral: Follow-up-based Nursing Care Protocol |
| Control Group: Routine Care | Experimental | Patients received routine perioperative nursing care. Data were collected during the perioperative period and via telephone follow-ups at 2 weeks, 6 weeks, 3 months, and 6 months post-discharge. Receives: Other: Control Group: Routin Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire Scores
Evaluation of the change in the Prolapse Quality of Life questionnaire scores, measured at baseline and across all post-discharge follow-up time points (2nd week, 6th week, 3rd month, and 6th month). This outcome measures general health perceptions, symptoms experienced during pelvic organ prolapse, and the impact of symptoms on quality of life across multiple domains, where higher scores indicate greater impairment in quality of life.
Measured: Baseline and at 2 weeks, 6 weeks, 3 months, and 6 months postoperatively
Change in Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) Scores
Evaluation of the change in sexual function scores of women who had pelvic organ prolapse surgery, measured at baseline and at the 6th-month final follow-up. The questionnaire consists of 12 items divided into three sub-dimensions (behavioral/emotional status, physical status, and partner-related status). Total scores range from 0 to 48, with higher scores indicating an improvement in sexual function.
Measured: Baseline and at 6 months postoperatively
Change in Pelvic Organ Prolapse Symptom Score (POP-SS)
Evaluation of the change in Pelvic Organ Prolapse Symptom Score (POP-SS), measured at baseline and across all post-discharge follow-up time points (2nd week, 6th week, 3rd month, and 6th month). This outcome measures the severity of urinary, bowel, and pelvic symptoms associated with pelvic organ prolapse, where higher scores indicate more severe symptoms.
Measured: Baseline and at 2 weeks, 6 weeks, 3 months, and 6 months postoperatively
Secondary outcomes (3)
Nursing Diagnoses Checklist Evaluation
Evaluation of nursing diagnoses used to identify potential problems and complications in patients undergoing pelvic organ prolapse surgery. These diagnoses are systematized across 11 areas according to Gordon's Functional Health Patterns model, using researcher-developed checklists across preoperative, postoperative, and all post-discharge follow-up periods (2nd week, 6th week, 3rd month, and 6th month). There is no composite score calculation; the frequencies and percentages of identified nursing diagnoses are evaluated.
Measured: Preoperatively, postoperatively, and at 2 weeks, 6 weeks, 3 months, and 6 months postoperatively
Patient Satisfaction Evaluation
Evaluation of patients' satisfaction levels with the nursing care received across the perioperative and home-care process, applied to both the intervention and control groups at the end of the study. Satisfaction is assessed using a 0 to 10 Visual Analog Scale (VAS), where 0 represents "Not satisfied at all" and 10 represents "Very satisfied." Higher scores indicate a higher level of satisfaction.
Measured: At the end of the 6-month follow-up period
Evaluation of Functional Health Patterns and Perioperative Patient Status
Evaluation of changes in patients' health status, problems, and potential complications across perioperative and post-discharge periods using researcher-developed evaluation forms based on Gordon's Functional Health Patterns (GFHP) framework (covering 11 health patterns, assessed via yes-no, 0-10 VAS, and 3-point Likert scales). Measured from baseline across all follow-up time points (preoperative, postoperative, 2nd week, 6th week, 3rd month, and 6th month) without a total composite score, with each pattern evaluated individually.
Measured: Baseline, postoperatively (24-48 hours), and at 2 weeks, 6 weeks, 3 months, and 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start1 Oct 2023
- Primary completion15 Oct 2025
- Study completion15 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled intervention trial After informed voluntary consent is obtained, full randomization technique will be used to assign participants to follow-up and control groups. Full randomization will be done via the website http://www.randomizer.org/. Two computer-generated randomization sequences will be applied on a one-to-one basis.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nazlı Özbek, Saglik Bilimleri Universitesi
- Investigators
- Gulsah Kök, Study director, SBU Health Science Faculty Gulhane Nursing Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06631508
- Sponsor's protocol ID
- nozbek
- Status last verified
- Feb 2026
- First submitted
- 16 Oct 2023
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Hendrix SL, Clark A, Nygaard I, Aragaki A, Barnabei V, McTiernan A. Pelvic organ prolapse in the Women's Health Initiative: gravity and gravidity. Am J Obstet Gynecol. 2002 Jun;186(6):1160-6. doi: 10.1067/mob.2002.123819.
PubMed 12066091Weintraub AY, Glinter H, Marcus-Braun N. Narrative review of the epidemiology, diagnosis and pathophysiology of pelvic organ prolapse. Int Braz J Urol. 2020 Jan-Feb;46(1):5-14. doi: 10.1590/S1677-5538.IBJU.2018.0581.
PubMed 31851453Rogers RG, Coates KW, Kammerer-Doak D, Khalsa S, Qualls C. A short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Int Urogynecol J Pelvic Floor Dysfunct. 2003 Aug;14(3):164-8; discussion 168. doi: 10.1007/s00192-003-1063-2. Epub 2003 Jul 25.
PubMed 12955337Hagen S, Glazener C, Sinclair L, Stark D, Bugge C. Psychometric properties of the pelvic organ prolapse symptom score. BJOG. 2009 Jan;116(1):25-31. doi: 10.1111/j.1471-0528.2008.01903.x. Epub 2008 Oct 8.
PubMed 18947342Digesu GA, Khullar V, Cardozo L, Robinson D, Salvatore S. P-QOL: a validated questionnaire to assess the symptoms and quality of life of women with urogenital prolapse. Int Urogynecol J Pelvic Floor Dysfunct. 2005 May-Jun;16(3):176-81; discussion 181. doi: 10.1007/s00192-004-1225-x. Epub 2004 Oct 21.
PubMed 15875234Zhang T, Qi X. Enhanced Nursing Care for Improving the Self-Efficacy & Health-Related Quality of Life in Patients with a Urostomy. J Multidiscip Healthc. 2023 Jan 29;16:297-308. doi: 10.2147/JMDH.S394515. eCollection 2023.
PubMed 36741293Rockefeller NF, Jeppson P, Komesu YM, Meriwether KV, Ninivaggio C, Dunivan G. Preferences for Preoperative Education: A Qualitative Study of the Patient Perspective. Female Pelvic Med Reconstr Surg. 2021 Oct 1;27(10):633-636. doi: 10.1097/SPV.0000000000001014.
PubMed 34554145Richardson K, Hagen S. The role of nurses in the management of women with pelvic organ prolapse. Br J Nurs. 2009 Mar 12-25;18(5):294-6, 298-300. doi: 10.12968/bjon.2009.18.5.40710.
PubMed 19374034Haya N, Feiner B, Baessler K, Christmann-Schmid C, Maher C. Perioperative interventions in pelvic organ prolapse surgery. Cochrane Database Syst Rev. 2018 Aug 19;8(8):CD013105. doi: 10.1002/14651858.CD013105.
PubMed 30121957Belayneh T, Gebeyehu A, Adefris M, Rortveit G, Gjerde JL, Ayele TA. Pelvic organ prolapse surgery and health-related quality of life: a follow-up study. BMC Womens Health. 2021 Jan 2;21(1):4. doi: 10.1186/s12905-020-01146-8.
PubMed 33388056
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of a Follow-up Based Nursing Care Protocol Developed for Women With Pelvic Organ Prolapse on Quality of Life and Sexual Functions
- ClinicalTrials.gov ID
- NCT06631508
- Acronym / sponsor ID
- nozbek
- Conditions
- Pelvic Organ Prolapse
- Keywords
- pelvic organ prolapse, perioperative care, follow up protocol, nursing care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 15 Oct 2025 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate the effects of a follow-up-based nursing care protocol-implemented during the perioperative and post-discharge home care processes-on pelvic organ prolapse symptoms, quality of life, and sexual functions in women who underwent surgery for pelvic organ prolapse.
The main questions it aims to answer are:
Is the follow-up-based nursing care protocol effective in reducing pelvic organ prolapse symptoms and improving quality of life and sexual functions? What are the comparative outcomes between the intervention group (receiving video-supported education and structured follow-ups at 2 weeks, 6 weeks, 3 months, and 6 months) and the control group (receiving routine perioperative nursing care)? Researchers will compare the intervention and control groups to determine the impact of the nursing care protocol on patients' recovery, quality of life, and symptom scores over a 6-month period.
Detailed description
In order to maintain holistic care, maintaining communication with the individual after discharge and providing individual counseling regarding the problems experienced have an important place in patient follow-up. In this context, perioperative consultancy should be provided under nurse management to make it easier for patients to cope with physical and psychosocial problems, improve quality of life and ensure continuity of care. Therefore, this randomized controlled trial was conducted to evaluate the effects of a follow-up-based nursing care protocol-implemented during the perioperative and post-discharge home care processes-on pelvic organ prolapse symptoms, quality of life, and sexual functions in women who underwent surgery for pelvic organ prolapse.
The study was carried out at the Gülhane Training and Research Hospital, Department of Obstetrics and Gynecology Clinic between October 15, 2023, and June 15, 2025. The sample of the research consisted of a total of 106 women who met the inclusion criteria (54 in the intervention group and 52 in the control group).
During the initial meeting, the Introductory Characteristics Form, Prolapse Quality of Life Questionnaire, Pelvic Organ Prolapse Symptom Score, Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire, Preoperative Period Patient Assessment Form, and Pelvic Organ Prolapse Nursing Diagnoses List were administered to all participants.
The intervention group received education via Preoperative and Post-discharge Home Follow-up Training Videos, and follow-up interviews were conducted at the 2nd week (1st follow-up), 6th week (2nd follow-up), 3rd month (3rd follow-up), and 6th month (4th follow-up) post-discharge. The control group received routine perioperative nursing care, with follow-up interviews conducted at the same intervals (2nd week, 6th week, 3rd month, and 6th month). At the final follow-up (6th month), both groups were administered the Prolapse Quality of Life Questionnaire, Pelvic Organ Prolapse Symptom Score, Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire, Post-discharge Patient Assessment Form, Pelvic Organ Prolapse Nursing Diagnoses List, and the Satisfaction Scale.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomized controlled intervention trial After informed voluntary consent is obtained, full randomization technique will be used to assign participants to follow-up and control groups. Full randomization will be done via the website http://www.randomizer.org/. Two computer-generated randomization sequences will be applied on a one-to-one basis.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group: Follow-up Nursing Care Protocol | Experimental | Behavioral: Follow-up-based Nursing Care ProtocolFollow-up Group: Patients received a follow-up-based nursing care protocol, including preoperative and post-discharge educational videos, structured telephone follow-ups at 2 weeks, 6 weeks, 3 months, and 6 months, and individual counseling. |
| Control Group: Routine Care | Experimental | Other: Control Group: Routin CarePatients received routine perioperative nursing care. Data were collected during the perioperative period and via telephone follow-ups at 2 weeks, 6 weeks, 3 months, and 6 months post-discharge. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Being stage ≥2 according to POP Classification (POP-Q),
- Being between 30-65 years old,
- Being sexually active,
- Ability to read and write,
- Ability to speak Turkish,
Key exclusion criteria (9 listed)
- Being stage <2 according to POP Classification (POP-Q),
- Being between <30 and >65 years of age,
- Not being sexually active,
- Not being able to read and write,
- Not being able to speak Turkish,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Follow-up-based Nursing Care ProtocolPatients in the intervention group received a structured follow-up-based nursing care protocol. They were shown preoperative and post-discharge home follow-up training videos. Post-discharge follow-up interviews and counseling were systematically conducted at the 2nd week (1st follow-up), 6th week (2nd follow-up), 3rd month (3rd follow-up), and 6th month (4th follow-up) to evaluate symptoms, quality of life, and sexual functions. | Behavioural | Intervention Group: Follow-up Nursing Care Protocol |
| Control Group: Routin CarePatients in the control group received routine perioperative nursing care. No special educational videos or structured follow-up protocols were administered by the researcher. Data were collected during the perioperative period and via routine telephone follow-ups at the designated intervals. | Other | Control Group: Routine Care |
Primary outcome
Change in Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire Scores
Time frame: Baseline and at 2 weeks, 6 weeks, 3 months, and 6 months postoperatively
Evaluation of the change in the Prolapse Quality of Life questionnaire scores, measured at baseline and across all post-discharge follow-up time points (2nd week, 6th week, 3rd month, and 6th month). This outcome measures general health perceptions, symptoms experienced during pelvic organ prolapse, and the impact of symptoms on quality of life across multiple domains, where higher scores indicate greater impairment in quality of life.
Change in Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) Scores
Time frame: Baseline and at 6 months postoperatively
Evaluation of the change in sexual function scores of women who had pelvic organ prolapse surgery, measured at baseline and at the 6th-month final follow-up. The questionnaire consists of 12 items divided into three sub-dimensions (behavioral/emotional status, physical status, and partner-related status). Total scores range from 0 to 48, with higher scores indicating an improvement in sexual function.
Change in Pelvic Organ Prolapse Symptom Score (POP-SS)
Time frame: Baseline and at 2 weeks, 6 weeks, 3 months, and 6 months postoperatively
Evaluation of the change in Pelvic Organ Prolapse Symptom Score (POP-SS), measured at baseline and across all post-discharge follow-up time points (2nd week, 6th week, 3rd month, and 6th month). This outcome measures the severity of urinary, bowel, and pelvic symptoms associated with pelvic organ prolapse, where higher scores indicate more severe symptoms.
3 secondary outcomes
Nursing Diagnoses Checklist Evaluation
Time frame: Preoperatively, postoperatively, and at 2 weeks, 6 weeks, 3 months, and 6 months postoperatively
Patient Satisfaction Evaluation
Time frame: At the end of the 6-month follow-up period
Evaluation of Functional Health Patterns and Perioperative Patient Status
Time frame: Baseline, postoperatively (24-48 hours), and at 2 weeks, 6 weeks, 3 months, and 6 months postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Background: PubMed 12066091Hendrix SL, Clark A, Nygaard I, Aragaki A, Barnabei V, McTiernan A. Pelvic organ prolapse in the Women's Health Initiative: gravity and gravidity. Am J Obstet Gynecol. 2002 Jun;186(6):1160-6. doi: 10.1067/mob.2002.123819.
- Background: PubMed 31851453Weintraub AY, Glinter H, Marcus-Braun N. Narrative review of the epidemiology, diagnosis and pathophysiology of pelvic organ prolapse. Int Braz J Urol. 2020 Jan-Feb;46(1):5-14. doi: 10.1590/S1677-5538.IBJU.2018.0581.
- Background: PubMed 12955337Rogers RG, Coates KW, Kammerer-Doak D, Khalsa S, Qualls C. A short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Int Urogynecol J Pelvic Floor Dysfunct. 2003 Aug;14(3):164-8; discussion 168. doi: 10.1007/s00192-003-1063-2. Epub 2003 Jul 25.
- Background: PubMed 18947342Hagen S, Glazener C, Sinclair L, Stark D, Bugge C. Psychometric properties of the pelvic organ prolapse symptom score. BJOG. 2009 Jan;116(1):25-31. doi: 10.1111/j.1471-0528.2008.01903.x. Epub 2008 Oct 8.
- Background: PubMed 15875234Digesu GA, Khullar V, Cardozo L, Robinson D, Salvatore S. P-QOL: a validated questionnaire to assess the symptoms and quality of life of women with urogenital prolapse. Int Urogynecol J Pelvic Floor Dysfunct. 2005 May-Jun;16(3):176-81; discussion 181. doi: 10.1007/s00192-004-1225-x. Epub 2004 Oct 21.
- Background: PubMed 36741293Zhang T, Qi X. Enhanced Nursing Care for Improving the Self-Efficacy & Health-Related Quality of Life in Patients with a Urostomy. J Multidiscip Healthc. 2023 Jan 29;16:297-308. doi: 10.2147/JMDH.S394515. eCollection 2023.
- Background: PubMed 34554145Rockefeller NF, Jeppson P, Komesu YM, Meriwether KV, Ninivaggio C, Dunivan G. Preferences for Preoperative Education: A Qualitative Study of the Patient Perspective. Female Pelvic Med Reconstr Surg. 2021 Oct 1;27(10):633-636. doi: 10.1097/SPV.0000000000001014.
- Background: PubMed 19374034Richardson K, Hagen S. The role of nurses in the management of women with pelvic organ prolapse. Br J Nurs. 2009 Mar 12-25;18(5):294-6, 298-300. doi: 10.12968/bjon.2009.18.5.40710.
- Background: PubMed 30121957Haya N, Feiner B, Baessler K, Christmann-Schmid C, Maher C. Perioperative interventions in pelvic organ prolapse surgery. Cochrane Database Syst Rev. 2018 Aug 19;8(8):CD013105. doi: 10.1002/14651858.CD013105.
- Results publication: PubMed 33388056Belayneh T, Gebeyehu A, Adefris M, Rortveit G, Gjerde JL, Ayele TA. Pelvic organ prolapse surgery and health-related quality of life: a follow-up study. BMC Womens Health. 2021 Jan 2;21(1):4. doi: 10.1186/s12905-020-01146-8.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gulsah Kök study director
SBU Health Science Faculty Gulhane Nursing Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Follow-up-based Nursing Care Protocol in people with Pelvic Organ Prolapse, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire Scores (time frame: Baseline and at 2 weeks, 6 weeks, 3 months, and 6 months postoperatively). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06631508, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.